Improving Maximal Strength in the Initial Postoperative Phase After Anterior Cruciate Ligament Reconstruction Surgery: Randomized Controlled Trial of an App-Based Serious Gaming Approach

Background Anterior cruciate ligament reconstruction surgery is one of the most common orthopedic procedures. One of the main factors that influence the outcome is regaining strength in the postoperative phase. Because anterior cruciate ligament reconstruction surgeries are often performed in young patients, we combined the concept of prehabilitation with an app-based serious gaming approach to improve maximal strength postoperatively. Objective Our objective was to conduct a prospective randomized trial to evaluate whether an app-based active muscle training program (GenuSport Knee Trainer) can improve postoperative strength by starting rehabilitation immediately after primary anterior cruciate ligament reconstruction surgery. Methods We designed a pilot study in which we randomly assigned patients receiving primary anterior cruciate ligament reconstruction to either the serious gaming training (intervention) group or a conventional rehabilitation (control) group. Except for the serious gaming-based training, both groups followed the same postoperative treatment protocol. Outcome parameters were absolute and relative change in maximal strength, as well as the International Knee Documentation Committee Subjective Knee evaluation form, Knee Injury and Osteoarthritis Outcome Score, and Lysholm Knee Score. Results In total 26 patients agreed to participate (14 patients in the intervention group and 12 patients in the control group, 1 of whom was lost to follow-up). We noted a difference in absolute maximum strength between the exergaming intervention and the control groups. Mean maximum strength preoperatively was 155.1 (SD 79.2) N in the intervention group (n=14) and 157.0 (SD 40.8) N in the control group (n=11). Postoperative mean maximum strength was 212.8 (SD 78.5) N in the intervention group and 154.5 (SD 27.1) N in the control group. Mean absolute change in maximum strength was 57.7 (SD 95.2) N in the intervention group and –4.8 (22.2) N in the control group. The analysis of covariance model with absolute change as the dependent variable and treatment group and baseline maximum strength as covariates showed a relevant difference in relative change between treatment groups (intervention – control) of 59.7 N (95% CI 10.1-109.3; P=.02). Similarly to the absolute increase, the relative change in maximum strength was relevantly higher in the exergaming group. The mean relative change in maximum strength was 1.7 (SD 1.17) in the intervention group and 1 (SD 0.13) in the control group. No adverse events or problems were reported during the study period. Conclusions Implementation of an app-based active muscle training program in the early postoperative therapy scheme was associated with an improvement in maximal strength. Therefore, we considered the use of GenuSport training after anterior cruciate ligament reconstruction to be a helpful complement to rehabilitation after anterior cruciate ligament reconstruction surgery to improve strength in the early postoperative phase. To our knowledge this was the first study to analyze immediate postoperative serious gaming-based training with the GenuSport device based on strength improvement.

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 otine 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.
subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study app based 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 brieuy explain why the item is not applicable/relevant for your study "An app based serious gaming approach in the initial postoperative phase after ACL reconstructions surgery to improve maximum strength -a randomized control trial" 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 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study ".. after ACL reconstructions surgery "

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) 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study "We designed a prospective randomized trial to evaluate whether an app based active muscle training program can improve the postoperative strength by starting rehabilitation immediately after primary ACL reconstruction surgery as already shown for patients who underwent total knee arthroplasty. To our knowledge this is the Urst study analyzing immediate postoperative serious gaming based training based on strength improvement. " 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 brieuy explain why the item is not applicable/relevant for your study "the serious gaming based training or at least three weeks both groups followed the same postoperative treatment protocol" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. otine), 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 otine 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 brieuy explain why the item is not applicable/relevant for your study the study was unblinded 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. 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 brieuy explain why the item is not applicable/relevant for your study "One problem of most of the currently available feedback controlled training systems is that the exercises mainly focus on range of motion and training is only possible with an acceptable range of motion. Therefore a device has been tested in patient rehabilitation after TKA focusing on feedback controlled active muscle training uncoupled from range of motion. ""In comparison to other already existing studies which mainly focus on the improvement of the range of motion rather than strength improvement our device can be used directly after 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 brieuy explain why the item is not applicable/relevant for your study "Therefore a device has been tested in patient rehabilitation after TKA focusing on feedback controlled active muscle training uncoupled from range of motion. The Genu Sport knee trainer was able to successfully improve the outcome after TKA especially in the immediate postoperative phase" 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 brieuy explain why the item is not applicable/relevant for your study "To our knowledge there are no studies which analyzed the effect of a muscle strength based training immediately after ACL surgery. This is why we developed the present randomized control trial" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…l=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study "The study design is a prospective randomized control trial. Patients awaiting primary ACL reconstruction surgery were recruited at a single tertiary healthcare center " "A computer based randomization was performed by generating a list of randomized numbers which have been provided in sealed envelopes by an independent examiner" 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 brieuy explain why the item is not applicable/relevant for your study none 3b-i) Bug Uxes, Downtimes, Content Changes Bug Uxes, 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 Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inuuenced study design such as staff Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. otine), 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 conUrmation, 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 brieuy explain why the item is not applicable/relevant for your study face to face assessments in the outpatient clinic "Patients awaiting primary ACL reconstruction surgery were recruited at a single tertiary healthcare center " 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 brieuy explain why the item is not applicable/relevant for your study 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 brieuy explain why the item is not applicable/relevant for your study The training data is collected directly in the device app. This has already been published before.
4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased 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 brieuy explain why the item is not applicable/relevant for your study no self questionnaires were used 4b-ii) Report how institutional ajliations are displayed Report how institutional ajliations are displayed to potential participants [on ehealth media], as ajliations 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) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…l=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 5) The interventions for each group with sujcient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study patients were not actively recruited. Patients who presented to the outpatient clinic and who already had an indication for all reconstruction surgery 5-i) Mention names, credential, ajliations of the developers, sponsors, and owners Mention names, credential, ajliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conuict 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 brieuy explain why the item is not applicable/relevant for your study "The KneeTrainer device has been already described in previous work by the group of Weber-Spickschen" already been published before https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study "The KneeTrainer device has been already described in previous work by the group of Weber-Spickschen"

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 brieuy explain why the item is not applicable/relevant for your study none were needed during the study period

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 brieuy explain why the item is not applicable/relevant for your study -v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing uowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing uowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc 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 brieuy explain why the item is not applicable/relevant for your study Your answer

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 brieuy explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study Patients who were randomised to the experimental group received the device including the app during they visit to the outpatient clinic "It consists of the strength monitoring unit with three integrated sensors which is placed in the popliteal area and a tablet with the application which allows to transfer the raised force into the game modus" "Each training session in our study takes around 5 minutes and is performed autonomously by the patient in his bed with 45° degrees of upper body evaluation while the patient holds the tablet in both hands" "The training application has two different modes as shown in one for the training itself and one analysis mode"

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 brieuy explain why the item is not applicable/relevant for your study "It consists of the strength monitoring unit with three integrated sensors which is placed in the popliteal area and a tablet with the application which allows to transfer the raised force into the game modus" 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 21generalizability).
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 brieuy explain why the item is not applicable/relevant for your study "Each training session in our study takes around 5 minutes and is performed autonomously by the patient in his bed with 45° degrees of upper body evaluation while the patient holds the tablet in both hands. By simply pushing his knee downward onto the measuring unit the patient can apply the force" 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 brieuy explain why the item is not applicable/relevant for your study no prompts were used https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 6a) Completely deUned pre-speciUed primary and secondary outcome measures, 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 brieuy explain why the item is not applicable/relevant for your study "The postoperative treatment protocol was apart from the use of the GenuSport knee trainer identically standardised" Meaning physiotherapy, mobilisation etc.
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 brieuy explain why the item is not applicable/relevant for your study "It consists of the strength monitoring unit with three integrated sensors which is placed in the popliteal area and a tablet with the application which allows to transfer the raised force into the game modus" "We analyzed all patients before and 6 weeks after the surgery. 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 brieuy explain why the item is not applicable/relevant for your study the study was performed as a pilot study.
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 brieuy explain why the item is not applicable/relevant for your study we saw no drop outs or adverse effects. the end point was identical with the Urst postoperative presentation https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 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 brieuy explain why the item is not applicable/relevant for your study "A computer based randomization was performed by generating a list of randomized numbers which have been provided in sealed envelopes by an independent examiner. " 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 brieuy explain why the item is not applicable/relevant for your study "A computer based randomization was performed by generating a list of randomized numbers which have been provided in sealed envelopes by an independent examiner. " 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 brieuy explain why the item is not applicable/relevant for your study "A computer based randomization was performed by generating a list of randomized numbers which have been provided in sealed envelopes by an independent examiner. " https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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 subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study "A computer based randomization was performed by generating a list of randomized numbers which have been provided in sealed envelopes by an independent examiner. " The allocation was performed postoperatively according to the number in the sealed envelope.
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 co-interventions (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 brieuy explain why the item is not applicable/relevant for your study "Due to the nature of this study blinding of patients or examiner was not possible. " https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 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) 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 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 brieuy explain why the item is not applicable/relevant for your study patients knew that the exergaming group was the internevention 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 brieuy explain why the item is not applicable/relevant for your study not relevant https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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 brieuy explain why the item is not applicable/relevant for your study "We analyzed all patients before and 6 weeks after the surgery. For the functional analysis IKDC score, Lysholm score, the Tegner activity scale, KOOS, the maximum strength level and the VAS have been measured. Additionally, we measured the femoral diameter 10cm and 20cm above the joint line. The statistical analysis was performed using IBM SPSS Statistics (IBM Inc., Armonk, New York)." 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 brieuy explain why the item is not applicable/relevant for your study 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 brieuy explain why the item is not applicable/relevant for your study "In the subgroup analysis of patients training more than two times a day showed no signiUcant difference in absolute and relative change of maximal strength but we saw a clear trend to higher strength levels in this group. "

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 brieuy 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 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 brieuy explain why the item is not applicable/relevant for your study Consent was obtained during the visit in the outpatient clinic 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 brieuy explain why the item is not applicable/relevant for your study The device was demonstrated in the postoperative and preoperative phase 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 brieuy explain why the item is not applicable/relevant for your study experimental (N=14) and control group (N=12) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential 14a) Dates deUning the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT uow 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 brieuy explain why the item is not applicable/relevant for your study "One patient of the control group was lost to 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 Ugures or tables demonstrating usage/dose/engagement.
Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Ugure 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 brieuy explain why the item is not applicable/relevant for your study the device was handed out for only 6 weeks https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) 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 brieuy explain why the item is not applicable/relevant for your study "We analyzed all patients before and 6 weeks after the surgery. For the functional analysis IKDC score, Lysholm score, the Tegner activity scale, KOOS, the maximum strength level and the VAS have been measured" 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiUcant 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 brieuy explain why the item is not applicable/relevant for your study none 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 brieuy explain why the item is not applicable/relevant for your study the trial was not stopped early. 16-i) Report multiple "denominators" and provide deUnitions Report multiple "denominators" and provide deUnitions: 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 speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "use" of the intervention.
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 brieuy explain why the item is not applicable/relevant for your study all patients were analysed in their group. other data is included in table 1 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 brieuy explain why the item is not applicable/relevant for your study pilot study character https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conUdence interval) subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study "Exergaming group. experimental (N=14) and control group ( 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 deUnitions 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 deUned (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 brieuy explain why the item is not applicable/relevant for your study "No one of the patients needed more than one instruction to use the knee trainer. 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 brieuy explain why the item is not applicable/relevant for your study "In the subgroup analysis of patients training more than two times a day showed no signiUcant difference in absolute and relative change of maximal strength but we saw a clear trend to higher strength levels in this group. "

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 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 brieuy explain why the item is not applicable/relevant for your study "Further studies are needed to prove these concepts and results. If the results of these further studies are as promising as the aforementioned we think that this might be a big step to implement such training strategies into the clinical routine protocols especially due to the fact that the positive aspects of serious gaming occur in all age cohorts.

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 brieuy explain why the item is not applicable/relevant for your study "The main limitations of our study are a comparatively small patient collective and a short follow up period of 6 weeks. This is due to the fact that our approach concerning the immediate postoperative strength based training is currently not implemented in postoperative protocols. "

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 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential OTHER INFORMATION 23) Registration number and name of trial registry 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 brieuy explain why the item is not applicable/relevant for your study in principle the study could be generalised to all Uelds of orthopaedic knee surgeries. Further studies are needed 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting 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 co-interventions) 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 brieuy explain why the item is not applicable/relevant for your study none 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 brieuy explain why the item is not applicable/relevant for your study registration will be performed now https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oimq…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 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) Conuicts of Interest (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential 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 brieuy explain why the item is not applicable/relevant for your study Figure 1 of the study 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 brieuy explain why the item is not applicable/relevant for your study the study itself was not funded. The publication was funded by MHH publication fonds X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (Unancial 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. STOP -Save this form as PDF before you click submit To generate a record that you Ulled 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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