key: cord-0785031-7t3och3v authors: Chae, Sang Hoon; Kim, Yushin; Lee, Kyoung-Soub; Park, Hyung-Soon title: Development and Clinical Evaluation of a Web-Based Upper Limb Home Rehabilitation System Using a Smartwatch and Machine Learning Model for Chronic Stroke Survivors: Prospective Comparative Study date: 2020-07-09 journal: JMIR Mhealth Uhealth DOI: 10.2196/17216 sha: 2b30288fd3dd718e85d1f31353be2dd50691f181 doc_id: 785031 cord_uid: 7t3och3v BACKGROUND: Recent advancements in wearable sensor technology have shown the feasibility of remote physical therapy at home. In particular, the current COVID-19 pandemic has revealed the need and opportunity of internet-based wearable technology in future health care systems. Previous research has shown the feasibility of human activity recognition technologies for monitoring rehabilitation activities in home environments; however, few comprehensive studies ranging from development to clinical evaluation exist. OBJECTIVE: This study aimed to (1) develop a home-based rehabilitation (HBR) system that can recognize and record the type and frequency of rehabilitation exercises conducted by the user using a smartwatch and smartphone app equipped with a machine learning (ML) algorithm and (2) evaluate the efficacy of the home-based rehabilitation system through a prospective comparative study with chronic stroke survivors. METHODS: The HBR system involves an off-the-shelf smartwatch, a smartphone, and custom-developed apps. A convolutional neural network was used to train the ML algorithm for detecting home exercises. To determine the most accurate way for detecting the type of home exercise, we compared accuracy results with the data sets of personal or total data and accelerometer, gyroscope, or accelerometer combined with gyroscope data. From March 2018 to February 2019, we conducted a clinical study with two groups of stroke survivors. In total, 17 and 6 participants were enrolled for statistical analysis in the HBR group and control group, respectively. To measure clinical outcomes, we performed the Wolf Motor Function Test (WMFT), Fugl-Meyer Assessment of Upper Extremity, grip power test, Beck Depression Inventory, and range of motion (ROM) assessment of the shoulder joint at 0, 6, and 12 months, and at a follow-up assessment 6 weeks after retrieving the HBR system. RESULTS: The ML model created with personal data involving accelerometer combined with gyroscope data (5590/5601, 99.80%) was the most accurate compared with accelerometer (5496/5601, 98.13%) or gyroscope data (5381/5601, 96.07%). In the comparative study, the drop-out rates in the control and HBR groups were 40% (4/10) and 22% (5/22) at 12 weeks and 100% (10/10) and 45% (10/22) at 18 weeks, respectively. The HBR group (n=17) showed a significant improvement in the mean WMFT score (P=.02) and ROM of flexion (P=.004) and internal rotation (P=.001). The control group (n=6) showed a significant change only in shoulder internal rotation (P=.03). CONCLUSIONS: This study found that a home care system using a commercial smartwatch and ML model can facilitate participation in home training and improve the functional score of the WMFT and shoulder ROM of flexion and internal rotation in the treatment of patients with chronic stroke. This strategy can possibly be a cost-effective tool for the home care treatment of stroke survivors in the future. TRIAL REGISTRATION: Clinical Research Information Service KCT0004818; https://tinyurl.com/y92w978t Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) ms#17216 TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title This study was preliminary study 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 "Internetbased" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline 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. 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 briefly explain why the item is not applicable/relevant for your study Development and Clinical Evaluation of "Web-based" Upper-limb Home Rehabilitation System using "Smartwatch" and Machine learning model for Chronic Stroke Survivors: Preliminary study 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 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 briefly explain why the item is not applicable/relevant for your study Methods: "The HBR system consisted of off-the-shelf smartwatch and the convolution neural network (CNN) of ML algorithm. This system was designed to detect the home exercises and report the exercise time of user to a physical therapist in charge". To figure out the most accurate way for detecting exercise of chronic stroke patients, we compared accuracy results with the dataset of personal/total data and accelerometer only/gyroscope/accelerometer + gyroscope data. From March 2018 to February 2019, we conducted a preliminary study with two groups of stroke survivors using the system. 17 and 6 participants were enrolled for analysis in HBR group and control group, respectively. The exercise compliance was periodically checked by phone calls in both groups. To measure clinical outcomes, we assessed the Wolf motor function test (WMFT), Fugl-meyer assessment of upper extremity (FMA-UE), grip power test, Beck depression inventory and range of motion (ROM) of the shoulder joint at O (baseline), 6 (mid-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 briefly explain why the item is not applicable/relevant for your study Your answer 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. offline), 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 offline 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) subitem not at all important essential subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study Your answer 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study Your answer 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 briefly explain why the item is not applicable/relevant for your study Goal of our HBR system was to solve the problem of high cost and laborintensiveness in home rehabilitation of chronic stroke patients. 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 briefly explain why the item is not applicable/relevant for your study Previous literatures have proven that continued home rehabilitation can activate neuroplasticity in chronic post-stroke patients and result in significantly enhanced clinical outcome. But, home rehabilitation of chronic stroke patient is costly and labor-intensive. We wanted to overcome these problems of home rehabilitation in chronic stroke patients by using our HBR system developed. 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 briefly explain why the item is not applicable/relevant for your study We conducted a preliminary study to evaluate the effectiveness of our HBR system. As the long-term goal of this study, we intended to investigate the benefits of using Al-based HBR compared to those of a conventional therapy. Herein, we compared the clinical outcomes of the experimental group using the HBR system with those of a contro| group by performing conventional home exercises. "We hypothesized that the experimental (HBR) group would show enhanced clinical outcomes than the control group. This paper elaborates on the technological advancements pertaining to the detection of home exercise activities using a smartwatch, the ML model, and the clinical results from the preliminary study." 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 briefly explain why the item is not applicable/relevant for your study Trial design was parallel. "We performed a preliminary study in two local healthcare centers located in two cities: Cheongju (Control group) and Daejeon (HBR group) in South Korea." Allocation ratio of results was 6:17. 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 briefly explain why the item is not applicable/relevant for your study Exclusion criteria were: (i) joint arthritis of the glenohumeral joint, (ii) rotator cuff tear, (iii) cervical root syndrome, (iv) subluxation of shoulder joint, (v) reluctance to follow the home exercise regimens of this study, and "(vi) do not have a smartphone with android OS." -We had to exclude subjects with I-phone since our HBR system was designed to be used in android OS. Bug fixes, 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 fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2]. Does your paper address subitem 3b-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 briefly explain why the item is not applicable/relevant for your study Your answer Does your paper address CONSORT subitem 4a? * 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 briefly explain why the item is not applicable/relevant for your study Inclusion criteria were "(i) age 40 to 70 years, (ii) mild to moderate neurologic deficit(MBI > 70) with hemiplegia, (iii) more than six months after the onset of stroke, (iv) 24 points or more in K-MMSE(Korean version of mini mental state examination) score and (v) possibility to understand the procedures and communicate with the supervisor." -Participants who had mental retardation was Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. 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 briefly explain why the item is not applicable/relevant for your study Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), 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 confirmation, 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 briefly explain why the item is not applicable/relevant for your study Participants were recruited offline in local healthcare centers. Exercise data was collected by internet. The assessment were performed every 6 weeks by physical therapist face to face. 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. subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study Home exercise data were collected in server computer in KAIST laboratory, DaeJeon, South Korea. 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. 페이지 19 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 3/22/2020 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrT... subitem not at all important essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 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 briefly explain why the item is not applicable/relevant for your study Primary outcome assessed by physical therapist every 6 weeks face-to-face (offline). Secondary outcome(Home exercise time) of experimental and control group were assessed online(HBR group) or phone-survey(Control group), Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations 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 briefly explain why the item is not applicable/relevant for your study Your answer 페이지 20 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript). 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 briefly explain why the item is not applicable/relevant for your study Your answer 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. 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 briefly explain why the item is not applicable/relevant for your study Your answer 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). 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 briefly explain why the item is not applicable/relevant for your study Your answer 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 briefly explain why the item is not applicable/relevant for your study Your answer Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting. 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 briefly explain why the item is not applicable/relevant for your study Your answer 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-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 briefly explain why the item is not applicable/relevant for your study "We implemented an HBR system which can connect patients and therapists at a distance. Figure 1 represents overview of our HBR system. To make the interface simple and userfriendly, we used a commercial smartwatch (watch style W270, LG, Seoul, South Korea) that can be connected to a personal smartphone after installing the custom programmed application. In our system, the smartwatch, which includes an inertial measurement unit (IMU) sensor, sent the sensor data to the smartphone via Bluetooth communication while patients were doing exercise. The personal smartphone served as a platform for receiving sensor data, classifying the data, and transmitting the results to a server computer via the subitem not at all important essential subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study Your answer 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). 페이지 26 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 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 briefly explain why the item is not applicable/relevant for your study Your answer 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 21generalizability). 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 briefly explain why the item is not applicable/relevant for your study "We also gave phone calls to participants in both groups once a week to encourage them to continue with the home exercise program" 페이지 27 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 3/22/2020 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrT... subitem not at all important essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 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 21generalizability. 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 briefly explain why the item is not applicable/relevant for your study Our intervention was not stand-alone intervention. We could not prohibit personal training such as sports like table tennis or walking in the pool. 페이지 28 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 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 briefly explain why the item is not applicable/relevant for your study Primary outcome "In Table 4 , we tried to find out the change of clinical results after the completion of home rehabilitation program which was a course of 12 weeks." Secondary outcome "To evaluate exercise compliance at home, we asked the participants in the control group how much time they exercised in a day. According to a verbal survey by phone, they did home exercise for about 13.6 (±4.85) minutes per day. While the numbers obtained for the control group might not be accurate due to the nature of a verbal survey, the smartphone application provided with the exact amount of exercise time for each patient in the HBR group. Figure 5 shows the results of HBR group. In average, participants in HBR group did the bilateral flexion exercise 7.27 (±10. 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 briefly explain why the item is not applicable/relevant for your study Your answer 페이지 31 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 3/22/2020 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrT... 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 briefly explain why the item is not applicable/relevant for your study "While doing the home rehabilitation program, four patients in the control group dropped out and the reason was unknown as they did not respond to our phone calls. In the HBR group, four patients gave up using our HBR system, as they were unfamiliar with the IT devices and experienced difficulties in their usage. One patient missed it due to the deterioration caused by other underlying diseases." 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 briefly explain why the item is not applicable/relevant for your study We recruited participants in two local health center as control and experimental group. So, random allocation was not applicable in our study. 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 briefly explain why the item is not applicable/relevant for your study We recruited participants in two local health centers as control and experimental group. So, random allocation was not applicable in our study. 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 briefly explain why the item is not applicable/relevant for your study Random allocation was not applicable in our study. So, we didn't have random allocation sequence. 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 briefly explain why the item is not applicable/relevant for your study Random allocation was not applicable in our study. So, we didn't have random allocation sequence. subitem not at all important essential subitem not at all important essential 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). 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 briefly explain why the item is not applicable/relevant for your study Participants were blinded about their method of intervention(control or HBR group). But, the outcome assessor was not blinded and same physical therapist performed assessment in both groups. 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". (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 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 briefly explain why the item is not applicable/relevant for your study Participants were blinded about their method of intervention(control or HBR group). But, the outcome assessor was not blinded and same physical therapist performed assessment in both groups. 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 briefly explain why the item is not applicable/relevant for your study Our study is an ehealth trial. 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 briefly explain why the item is not applicable/relevant for your study Primary outcome "We used descriptive statistics to characterize the demographics and analyzed the difference between control and HBR group on baseline by Mann-Whitney U test. We compared the clinical results of functional recovery (WMFT, FMA-UE), grip power, Beck depression inventory, and range of motion by Friedman test. As a post-hoc analysis, the Wilcoxon signed rank test with Bonferroni correction method was used. SPSS software was utilized for all the statistical analysis (SPSS statistics 25, IBM, NY, USA)." Secondary outcome -We did not use statistical analysis. We just compared the 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]). 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 briefly explain why the item is not applicable/relevant for your study Imputation techniques was not used because patient who dropped out was not able to be assessed for the outcome. We performed the analysis based on the data of participants who completed our 12 weeks intervention. subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study "According to the post-hoc analysis of the Wilcoxon-signed rank test with the Bonferroni correction, shoulder joint ROM with flexion (P =.004) and internal rotation (P =.001) showed a significant increase in the first 6 weeks of home 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 briefly explain why the item is not applicable/relevant for your study Your answer 페이지 37 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Outline informed consent procedures e.g., if consent was obtained offline 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. 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 briefly explain why the item is not applicable/relevant for your study Your answer 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) 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 briefly explain why the item is not applicable/relevant for your study Your answer 페이지 38 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 3/22/2020 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrT... 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 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 briefly explain why the item is not applicable/relevant for your study The number of care providers in control(3) and experimental group(3) -Care providers were same in both groups. The number of participants was six in control group and seventeen in experimental group. 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 briefly explain why the item is not applicable/relevant for your study Not applicable since our study is not randomized trial 페이지 39 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 3/22/2020 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrT... 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 figures or tables demonstrating usage/dose/engagement. Copy and paste relevant sections from the manuscript or cite the figure 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study Indicate if critical "secular events" fell into the study period, e.g., significant 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study Not relevant 페이지 41 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 3/22/2020 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrT... subitem not at all important essential 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 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 briefly explain why the item is not applicable/relevant for your study " Table 2 represents the demographics and baseline assessment with no significant differences between the two groups. " 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 briefly explain why the item is not applicable/relevant for your study As an inclusion criteria, we included only participants who showed "24 points or more in KMMSE(Korean version of mini mental state examination) score" and "possibility to understand the procedures and communicate with the 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 briefly explain why the item is not applicable/relevant for your study Figure 4 shows time Flow of the study. According to the Criteria, we excluded two patients in the control group due to shoulder pain during exercise. In the HBR group, four patients were excluded: one patient had rotator cuff repair surgery before, one had shoulder subluxation, and two had shoulder pain during exercise. After excluding those patients, 10 and 22 patients were initially enrolled in this study. While doing the home rehabilitation program, four patients in the control group dropped out and the reason was unknown as they did not respond to our phone calls. In the HBR group, four patients gave up using our HBR system, as they were unfamiliar with the IT devices and experienced difficulties in their usage. One patient missed it due to the deterioration caused by other underlying diseases. Finally, "6 patients in the control group and 17 patients in the HBR group completed the protocol at 12 weeks". To figure out the changes of clinical scores, we tried to conduct an assessment at 6 weeks after the final assessment (18 weeks). control group did not reply to our call whereas participants in HBR group subitem not at all important essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 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 briefly explain why the item is not applicable/relevant for your study 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 definitions 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 defined (e.g., timeout after idle time) [1] (report under item 6a). 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 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study No binary outcome variables in our study. 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 briefly explain why the item is not applicable/relevant for your study According to the post-hoc analysis of the Wilcoxon-signed rank test with the Bonferroni correction, shoulder joint ROM with flexion (P =.004) and internal rotation (P =.001) showed a significant increase in the first 6 weeks of home 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study Only six participants of the control group data were enrolled in a data analysis process. However, while carrying out our research, losing subjects was inevitable in the control group because "they were tired of receiving calls of management without any benefit", indicating the limitation of a conventional method. subitem not at all important essential subitem not at all important essential 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]. 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 briefly 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 briefly explain why the item is not applicable/relevant for your study "In this study, we developed the HBR system using a commercial smartwatch with the ML model, and evaluated the effectiveness of the HBR system via a preliminary study. The machine learning model based on CNN algorithm showed good to excellent accuracy results (Range: 86.5%~100%) and the preliminary study showed a significant increase in terms of ROM and WMFT function score." Highlight unanswered new questions, suggest future research. 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 briefly explain why the item is not applicable/relevant for your study Your answer 페이지 50 / 58 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 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 briefly explain why the item is not applicable/relevant for your study "There are several limitations to this study. First, the total number of patients who completed our research was relatively small to derive statistically strong evidence, particularly in the control group. Nevertheless, this result can be grounded as a preliminary study for a future study dealing with home rehabilitation with a large number of subjects. Second, there was a discrepancy in the number of subjects in the control and experimental group. Only six participants of the control group data were enrolled in a data analysis process. However, while carrying out our research, losing subjects was inevitable in the control group because they were tired of receiving calls of management without any benefit, indicating the limitation of a conventional method." Third, there could be a loss of time measurement in the experimental group since some patients in the experimental group appealed that they sometimes did home exercise without the smartwatch due to the inconvenience of wearing smartwatch. Therefore, we think the exercise time stored in the database was underestimated than the real value of home exercise time. Fourth, "the actual accuracy of exercise detection at home was not assessed. Although some researchers have attempted to address the privacy preservation of sensitive personal data based on deep learning algorithm [51], we did not implement it and only calculated the accuracy based on a five-fold cross-validation test. Therefore, the actual accuracy, which is the correct prediction rate of exercise detection at home, was not able to be assessed because all the patients wanted to protect their privacy". Fifth,"there could have been a selection bias that arose from the local health centers being positioned at different locations. However, we 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial subitem not at all important essential subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study Your answer 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 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. 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 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 briefly explain why the item is not applicable/relevant for your study " Figure 4 shows time Flow of the study." According to the criteria, we excluded two patients in the control group due to shoulder pain during exercise. In the HBR group, four patients were excluded: one patient had rotator cuff repair surgery before, one had shoulder subluxation, and two had shoulder pain during exercise. After excluding those patients, 10 and 22 patients were initially enrolled in this study. "While doing the home rehabilitation program, four patients in the control group dropped out and the reason was unknown as they did not respond to our phone calls. In the HBR group, four patients gave up using our HBR system, as they were unfamiliar with the IT devices and experienced difficulties in their usage. One patient missed it due to the deterioration caused by other underlying diseases. Finally, 6 patients in the control group and 17 patients in the HBR group completed the 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 briefly explain why the item is not applicable/relevant for your study "This paper is based on a research which has been conducted as part of the KAISTfunded Global Singularity Research Program for 2020." 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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 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 briefly explain why the item is not applicable/relevant for your study Institutional Review Board in KAIST 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 subitem not at all important essential 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 briefly explain why the item is not applicable/relevant for your study Your answer 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).subitem not at all important essentialAbout 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 (financial 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. 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 briefly explain why the item is not applicable/relevant for your study As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist? How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group?This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document