The Effectiveness of Video-Based Game Exercise Therapy Applications in Pes Planus Rehabilitation: Protocol for a Randomized Controlled Trial

Background Pes planus is one of the most common foot deformities. Although there are many studies on the effectiveness of various exercise methods in pes planus rehabilitation, the number of studies on video-based game exercise therapy applications is very limited. Objective This study aims to evaluate the effectiveness of 2 video-based game exercise therapies and structured exercise practices in pes planus rehabilitation. Methods This study is a 3-arm, parallel-group, single-blinded randomized controlled trial. The study will include 69 patients with flexible pes planus aged between 18 and 25 years who attend the orthopedics and traumatology clinic and meet the inclusion criteria. The primary outcomes are measures of navicular drop and pedobarographic analysis before and after the intervention, and the secondary outcomes include balance, femoral anteversion, and lower extremity muscle strength. Participants will be evaluated with a navicular drop test for medial longitudinal arch height, a pedobarographic analysis system for plantar pressure analysis, a Craig test for femoral anteversion, the Becure Balance System for balance measurement, and a myometer device for lower extremity muscle strength measurement. Participants will be randomly assigned to a structured exercise group, an exergame group, or a serious game group according to their order of arrival. The structured exercise group will use a short foot exercise, a towel-picking exercise, and various walking and balance exercises. Patients in the serious play group will play the lower extremity games in the Becure Balance System. Patients in the exergame group will play balance games on the Nintendo Wii game console. All participants will participate in 18 exercise sessions (3 days a week for 6 weeks). After the treatment, the initial measurements will be repeated. Results The study started in January 2023. It is expected to be completed in June 2024. Conclusions This study will be the first randomized controlled study to evaluate the effectiveness of 2 different video-based game exercise therapy applications in pes planus rehabilitation. Through this study, the use of video-based game exercise therapy in pes planus rehabilitation, together with the developing technology, will be a guide. In addition, a new exercise protocol, including serious game exercises, will be added to the literature. In the future, it is expected that our study on the development of different game systems, especially for the ankle, will provide pioneering feedback. Trial Registration ClinicalTrials.gov NCT05679219; https://clinicaltrials.gov/study/NCT05679219 International Registered Report Identifier (IRRID) DERR1-10.2196/51772


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dGl… 9/75 subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The Effectiveness of ''Video-Based Game Exercise Therapy Applications'' in Pes Planus Rehabilitation: Study Protocol For a Randomized Controlled Trial

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").

Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The Effectiveness of Video-Based Game Exercise Therapy Applications in ''Pes Planus'' Rehabilitation: Study Protocol For a Randomized Controlled Trial 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dGl… 11/75 subitem not at all important 1 2 3 4 5 essential 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Methods: ''This study is a 3-arm, parallel-group, single blinded randomized controlled trial. 69 cases of flexible pes planus aged between 18-25, who applied to the orthopedics and traumatology clinic and met the inclusion criteria, will be included in the study. Participants will be randomly assigned to one of 3 groups according to the order of arrival. The primary outcomes are measures navicular drop and pedobarographic analysis before and after intervention, and the secondary outcomes include balance, femoral anteversion and lower extremity muscle strength. cases will be randomized to three different exercise groups: structured pes planus exercise group, exergame, and serious game group, and will be subjected to 18 sessions. ''After the treatment, the initial measurements will be repeated.
12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 12/75 subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 13/75 subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional o ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Pes planus is a pathology that requires long-term rehabilitation. Considering the secondary pathologies that the deformity may cause, rehabilitation protocols with high participation from the early period are needed. Herein, VBGE treatments, which are becoming increasingly widespread in rehabilitation with the development of technology, come to mind. In the literature, it is possible to see VBGE treatments with names such as exergame, serious game, and rehabilitative game. subitem not at all important 1 2 3 4 5 essential 2a-ii) Scientific background, rationale: What is known about the (type of) system Scienti c background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this speci c study, from which stakeholder viewpoint is the study performed, potential impact of ndings [2]. Brie y justify the choice of the comparator.
Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Exergame; is the therapeutic application of commercially developed video games in an exercise form. Exergame applications include games such as Nintendo Wii, Microsoft X-box Kinect, and Playstation Move, produced for entertainment purposes and frequently used in rehabilitation. [19,20]. It has been reported that Microsoft Xbox lower extremity games applied for 12 sessions in patients with flexible pes planus improve balance and navicular drop [12]. Serious games is the name given to the games developed for rehabilitation purposes, not for entertainment purposes. Games are developed specifically for a specific disease group or disease symptoms. Thus, it is aimed to provide rehabilitation by increasing active participation in therapy with higher motivation. One of the systems developed for this purpose is; Becure system, formerly known as Fizyosoft. Becure System has software that can work integrated with the Wii Balance Board. Studies in the literature show that Becure games give positive results in different disease groups [21][22][23][24][25]. However, there is no study conducted with serious game with pes planus. 2b) In INTRODUCTION: Specific objectives or hypotheses METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Today, the rapid development of technology and patients' search for new treatments have made it necessary to add these technologies to the rehabilitation process. There are many studies in the literature on VBGE therapy in different patient groups. However, there is a lack of literature regarding VBGE therapy in individuals with flexible pes planus. There is only one study with Xbox Kinect [12]. Thus we aim to compare the effects of different exercise protocols on functional parameters in pes planus rehabilitation. Also, our study will contribute to the literature as it is the first study to compare wii-based exergame and wiibased serious game exercise protocols.
Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Study design This study has been registered with Clinical Trials.gov PRS NCT05679219. It is a 3-arm, parallel-group, single blinded randomized controlled trial. subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants will be created from individuals aged 18-25 who apply to Medipol Mega University Hospital Orthopedics and Traumatology Department. Sixty-nine individuals who volunteered to participate and met the inclusion criteria will be included in the study. Inclusion criteria were a navicular drop of more than 10 mm, flexible pes planus, and no previous insoles or exercise therapy. At the same time, since excess weight can affect pes planus, people with body mass index within the normal range (18-24.9) will be taken. The orthopedic or neurological problem affecting lower extremities and balance, history of surgery or trauma in the last six months, Individuals with diabetes, pregnancy, and visual or auditory problems will be excluded from the study.

3b-i) Bug fixes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
subitem not at all important 1 2 3 4 5 essential 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.

Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants will be created from individuals aged 18-25 who apply to Medipol Mega University Hospital Orthopedics and Traumatology Department. Participants will be evaluated before and after treatment. The participants' pedobarographic analysis, balance, flexibility, navicular drop, femoral anteversion, and lower extremity muscle strength measurements will be taken in this context. Measurements will be taken by an experienced therapist who is different from the therapist performing the exercises. The therapist performing the measurements will perform the randomization. subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The study will be carried out in Istanbul Medipol University Physiotherapy Laboratory. subitem not at all important 1 2 3 4 5 essential 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study All data collection processes in our study will be carried out face to face. 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 4b-ii) Report how institutional affiliations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results)

Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 26/75 subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 30/75 subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants will be created from individuals aged 18-25 who apply to Medipol Mega University Hospital Orthopedics and Traumatology Department. Sixty-nine individuals who volunteered to participate and met the inclusion criteria will be included in the study. At the beginning, participants will be given detailed information about the study. Then, a written informed voluntary consent form will be signed stating that they agree to participate in the study. Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants will be treated by a specialist physiotherapist three days a week for six weeks, with 18 sessions of 40 minutes each. The same therapist will follow the exercises of all three groups. Structured Pes Planus Exercise Group : In this group, short foot exercise, towel curl, walking (toe, heel, tandem), eccentric gastro soleus stretching, object picking with fingers, and balance on one leg will do exercises ( Figure 4). The primary purpose of the exercises, To increase the MLA, especially by contracting the foot intrinsic muscles, is to improve the balance simultaneously. Walking exercises will be performed in 10 meters and ten rounds, other exercises will be performed with 30 repetitions for both feet, and the whole session will be 40 minutes in total. The first two sessions with the participants will be faceto-face with the therapist. Then an e-mail with photos and videos of the exercises will be sent. The remaining sessions will be followed online and supervised by the therapist every three sessions. Wii Based Exergame Group : Balance games from the Nintendo Wii game console, frequently used in different disease groups in the literature, will be played to this group. In this context, five games will be played for a total of 40 minutes, 8 minutes each, under the supervision of a specialist physiotherapist ( Figure 5). It will be noted that the person should not transfer weight to the medial part of the foot. Wii-Based Serious Game Group : This group will play the games in the Becure Balance System. Three games considered suitable for the cases will be played under the supervision of an expert physiotherapist for 40 minutes in each session ( Figure 6). It will be noted that the person should not transfer weight to the medial part of the foot.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.

Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The first two sessions with the participants will be held face to face with the therapist. An email with photos and videos of the exercises will then be sent. The remaining sessions will be followed online and supervised by a therapist every three sessions. It will be this way only in the structured exercise group. All sessions in the other two intervention groups will be conducted face-to-face with a therapist. including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There was no e-intervention in our study. Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The primary outcomes are measures navicular drop and pedobarographic analysis, and the secondary outcomes include balance, femoral anteversion and lower extremity muscle strength. Participants will be evaluated before and after treatment. Measurements will be taken by an experienced therapist who is different from the therapist performing the exercises. The therapist performing the measurements will perform the randomization. Pedobarographic analysis The pedobarographic analysis will be done in two steps, statically and dynamically, with the Sensor Medica Maxi brand device (Sensormedica, Guidonia Montecelio, Rome, Italy). Static analysis data will be recorded while standing upright. Dynamic analysis data will be taken while walking on the platform six times. Data such as ankle valgus angle, medial arch, lateral arch, medial heel, lateral heel surface area (cm²), and load (%) will be recorded. Plantar pressure analyses will be determined through the FreeStep software, which is compatible with the device (Figure 2) [26]. Navicular drop The navicular drop test will determine the severity of pes planus. A navicular drop greater than 10 mm is an inclusion criterion. As a result of the exercises, the measurement will be repeated and checked whether the difference has decreased [27]. Femoral anteversion The femoral anteversion angle will be evaluated with the Craig test. The person will be prone, with the knees flexed to 90 degrees. In this position, individuals will be asked to rotate their lower extremities internally. The resulting angle will be measured with a goniometer [28]. Balance measurements will be evaluated with the Becure Balance System (Becureglobal, Mannheim, Germany). The validity and reliability study of the Balance Board balance device, which works were integrated with Becure, was conducted by Tarakcı et al. [24]. In this context, measurements of individuals with eyes open and closed on both feet and single feet will be taken ( Figure 3). The system reports the oscillation in cm to stay balanced during the measurements [24]. The decrease in oscillation after treatment is interpreted as improvement. Muscle strength Participants; Muscle strength of lower extremity dorsiflexor, plantar flexor, inverter, evertor, knee flexor, knee extensor, and hip flexor muscle groups will be measured with a Lafayette myometer device (Pelican 1150 Case, Pelican Products, Torrance, CA USA). Results will be recorded in Newtons [30]. Flexibility Flexibility will be evaluated with the Jack test [29]. The test is positive if MLA is formed by passive extension of the first finger. This test is one of the most important indicators that the pes planus deformity is flexible and that the foot shape can be achieved with exercise. subitem not at all important 1 2 3 4 5 essential 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Yanıtınız Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No changes were made after the research started.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 44/75 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study If the participant does not want to continue due to any health problem or any other reason, they will be excluded from the study.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants will be divided into 3 groups using the simple randomization method, according to the order of arrival, via the site randomizer.org. Measurements will be taken by an experienced therapist who is different from the therapist performing the exercises. The therapist performing the measurements will perform the randomization.
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants will be divided into 3 groups using the simple randomization method, according to the order of arrival, via the site randomizer.org. 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants will be divided into 3 groups using the simple randomization method, according to the order of arrival (1:1:1), via the site randomizer.org. Participants will be divided into 3 groups using the simple randomization method (1:1:1) according to the order of arrival on the site randomizer.org. Participants do not know which exercise group they will be included in and the differences between the exercises.
Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Measurements will be taken by an experienced therapist who is different from the therapist performing the exercises. The therapist performing the measurements will create the random allocation order, enroll the participants, and assign the participants to the interventions. 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The participants and the therapist who made the assessments were blinded.

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 48/75 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Similar balance and lower extremity exercises were included in all three intervention Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Data will be statically analyzed using the SPSS 25.0 (SPSS Inc., Chicago, Illinois, ABD) program. Normality tests (visual and analytical) will be applied. Descriptive statistics will be expressed as arithmetic mean ± standard deviation. As a result of the normality evaluation, analyzes will be carried out with tests suitable for the distribution of the groups. Statistical analyzes will be interpreted according to the significance level of p<0.05. subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The data of a total of 69 participants, independent of the cases excluded in the study, will be analyzed.

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Data will be statically analyzed using the SPSS 25.0 (SPSS Inc., Chicago, Illinois, ABD) program. Normality tests (visual and analytical) will be applied. Descriptive statistics will be expressed as arithmetic mean ± standard deviation. As a result of the normality evaluation, analyzes will be carried out with tests suitable for the distribution of the groups. Statistical analyzes will be interpreted according to the significance level of p<0.05.

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 53/75 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is a protocol study. Data collection continues. The results will be evaluated at the end of the study.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 54/75 subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up 13b-i) Attrition diagram Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is a protocol study. Study started in January 2023. It is expected to be completed in June 2024. 14b) Why the trial ended or was stopped (early) 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 56/75 15) A table showing baseline demographic and clinical characteristics for each group NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is a protocol study. Data collection continues.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known. Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is a protocol study. Data collection continues.

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention. 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is a protocol study. Data collection continues.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is a protocol study. Data collection continues.
17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 60/75 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is a protocol study. Data collection continues.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is a protocol study. Data collection continues.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group 19-ii) Include qualitative feedback from participants or observations from staff/researchers Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
This study aims to evaluate the effectiveness of two VBGE applications (exergame and serious game) and structured exercise practices in pes planus rehabilitation. The effect of exercise protocols on functional parameters such as navicular drop, muscle strength, balance, and plantar pressure will be evaluated. It has been reported in the literature that exercises for lower extremity muscle groups provide improvement in functional parameters.Lynn et al., in their study, compared the short foot exercise and towel curl exercise that they had 100 repetitions per day for four weeks; they determined that short foot exercise improved dynamic balance more [8]. Kim et al. have compared the effects of short foot exercise and insoles applied three days/week for five weeks in individuals with flexible pes planus. They reported that short foot exercises improved navicular drop and dynamic balance more [14]. Ravichandran et al. compared the effects of concentric and eccentric tibialis posterior strengthening exercises in individuals aged 18-25 with flexible pes planus. Like our study, the participants had exercised such as resistant dorsiflexion, plantar flexion and inversion, towel curls, and fingertip elevation. They determined that both concentric and eccentric exercises improved navicular drop equally [16]. Goo et al. evaluated the relationship between navicular drop and muscle activation during walking of two exercise protocols given to individuals with pes planus. They gave abductor hallucis strengthening exercises combined with gluteus maximus to one group and abductor hallucis strengthening exercises to another group. They reported that gluteus maximus strengthening exercises are important in recovering navicular drop and providing a typical gait pattern [11]. Engkananuwat et al. evaluated the effects of performing gluteus medius strengthening exercises in addition to foot exercises in individuals with flexible pes planus. For 4 weeks, one group had short foot exercise and the other group had hip strengthening exercise in addition to the foot exercise. As a result, hip exercises added to foot exercise; determined that it was more effective in reducing medial plantar pressure, static balance, and navicular drop data [31]. The exercise protocols in our study are similar to the studies in the literature. The biomechanics of the foot directly affects the whole body's posture and gait. Considering the studies in the literature, it is not sufficient to only strengthen the intrinsic foot muscles in pes planus rehabilitation. Strengthening the other lower extremity muscles is also very important. In parallel with the literature, there are strengthening exercises for all lower extremity muscles in all three groups in our study. In recent years, VBGE therapy applications have been used frequently in orthopedic rehabilitation, with the patients' search for new treatments and the development of technology. There are studies showing that video-based exercise applications give positive results in different patient groups [19][20][21][22][23][24][25]. However, there are insufficient studies on these applications in pes planus rehabilitation. There is only one study in cases with pes planus. Şahan et al. divided 40 patients with flexible pes planus into two groups and compared the effects of Microsoft Xbox Kinect lower extremity games, and short foot exercises performed three days/week for four weeks. They determined a significant improvement in both groups' navicular drop and balance data after treatment. They reported that VBGE is an effective exercise method in patients with pes planus. However, the study's limitations are the limited number of participants, the short duration of treatment, such as 12 sessions, and the lack of objective evaluation methods [12]. Our study will contribute to the literature as it is the first to compare Nintendo Wii games and Wii-based serious game protocols in pes planus rehabilitation. At the same time, it will be determined whether video-based game exercise applications are superior to structured exercise applications. We aim to reach the most objective results to determine whether there is a superiority between our measurement methods and different exercise protocols. The use of VBGE therapy in the rehabilitation of Pes Planus will be guiding Also this study will bring a new exercise protocol including serious game relevant, multiplicity of analyses will be guiding. Also, this study will bring a new exercise protocol, including serious game exercises, to the literature. In the future, it is expected that our study on the development of different game systems, especially for the ankle, will be a pioneer by providing feedback.

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Limitations have not been evaluated since the study has not been completed yet.

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız 12.08.2023 00:51 CONSORT-EHEALTH (V 1.6.1) -Subm ss on/Publ cat on Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_O mqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/v ewform?hl=en_US&formkey=dG… 71/75 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Conflicts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Trial registration: This study has been registered with Clinical Trials.gov PRS C 0 9219 Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Trial registration: This study has been registered with Clinical Trials.gov PRS C 0 9219 Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Source of funding This study was entitled to be supported for 12 months with the project decision letter dated 19/01/2023 and numbered 222S879 within the scope of Tübitak 1002-A Rapid Support Module. About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yanıtınız As a result of using this checklist, did you make changes in your manuscript? * STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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