{"paper_id":"0d8a5ff5-26bc-439a-b11b-98abc0b5437d","body_text":"Telerehabilitation compared with unsupervised home exercise for knee osteoarthritis: study protocol for a single-centre, parallel-group randomised controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Telerehabilitation compared with unsupervised home exercise for knee osteoarthritis: study protocol for a single-centre, parallel-group randomised controlled trial Petra Kotnik, Karmen Erjavec, Mohsen Hussein This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8001912/v1 This work is licensed under a CC BY 4.0 License Status: Under Revision Version 1 posted 5 You are reading this latest preprint version Abstract Background Knee osteoarthritis (OA) is one of the leading causes of disability worldwide, with increasing prevalence and high societal and economic burden. Exercise-based rehabilitation is recommended as first-line management, yet adherence to unsupervised home exercise is often low. Telerehabilitation has the potential to improve access, adherence, and clinical outcomes; however, high-quality randomised controlled trials (RCTs) directly comparing structured telerehabilitation with unsupervised exercise remain scarce. Methods This study is a single-centre, parallel-group randomised controlled trial designed to evaluate the effectiveness of a 3-month telerehabilitation programme compared with unsupervised home-based exercise in patients with knee OA. A total of 120 patients with radiographically confirmed knee OA (Kellgren-Lawrence grade 1–3) will be randomised in a 1:1 ratio to either the telerehabilitation (TR) group or the control (unsupervised exercise, UE) group. Both groups will follow the same standardized exercise protocol, consisting of strengthening, mobility, and balance exercises performed three times per week. The TR group will additionally receive weekly remote supervision via phone or video consultations, supplemented with electronic reminders and motivational support. Trial registration ClinicalTrials.gov NCT07137897. Registered on 26 August 2025. Unique Protocol IdL750184 retrospectively registered. Knee osteoarthritis Telerehabilitation Exercise therapy Digital health Home-based exercise Randomised controlled trial Rehabilitation adherence Physical function Health-related quality of life Patient satisfaction Figures Figure 1 Figure 2 Administrative information Title {1} Telerehabilitation compared with unsupervised home exercise for knee osteoarthritis: study protocol for a single-centre, parallel-group randomised controlled trial Trial registration {2a and 2b}. ClinicalTrials.gov NCT07137897 Protocol version {3} Unique Protocol IdL7-50184 Funding {4} The Slovenian Research and Innovation Agency and Artros d.o.o. [grant number L7-50184] supported this work Author details {5a} Petra Kotnik, Faculty of Health, University of Novo Mesto, Novo Mesto, Slovenia, [email protected] Karmen Erjavec, Faculty of Health, University of Novo Mesto, Novo Mesto, Slovenia, [email protected] Mohsen Hussein, Artros d.o.o, Tehnološki park 19, Ljubljana, 1000, Slovenia; [email protected] Name and contact information for the trial sponsor {5b} Applied research project ARIS - Public Agency for Science, Research and Innovation of the Republic of Slovenia and co-financed by Artros, d.o.o Project leader and Contact person: Prof. Dr. Karmen Erjavec, [email protected] Role of sponsor {5c} The co-founder had a partial role in the study design, data collection, management, analysis, and interpretation, as well as in the preparation of the study report. The authors had full access to all data and take full responsibility for the integrity of the data and the accuracy of the data analysis. The final decision to submit the manuscript for publication was made independently by the authors. Introduction Background and rationale {6a} Knee osteoarthritis (OA) is among the most common chronic musculoskeletal disorders and a leading cause of disability worldwide [ 1 ]. Its global prevalence is approximately 23% in adults over the age of 40 [ 2 ] and continues to rise due to demographic ageing, increased life expectancy, obesity, and the absence of disease-modifying pharmacological therapies [ 3 – 5 ]. OA of the knee joint is particularly burdensome, contributing not only to pain, stiffness, inflammation and reduced mobility but also to significant limitations in independence, productivity and quality of life [ 6 , 7 ]. The societal and economic impact is substantial, with OA ranking as one of the most common causes of long-term disability and accounting for a considerable share of health service costs [ 8 ]. Direct costs include surgery, pharmacotherapy, and healthcare utilisation, while indirect consequences such as work absenteeism, early retirement, and increased cardiovascular risk due to inactivity further add to its burden [ 9 ]. Self-management, especially exercise therapy, remains the cornerstone of non-pharmacological treatment for knee OA [ 10 ]. Regular physical activity has been shown to alleviate symptoms, enhance joint mobility and improve health-related quality of life [ 11 ]. The World Health Organization recommends at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity weekly for adults, including older adults [ 12 , 13 ]. Despite these guidelines, adherence to unsupervised home-based exercise programmes is frequently poor [ 14 ], and patients often face barriers related to motivation, pain, and limited professional support [ 15 ]. Telerehabilitation, defined as the remote delivery of rehabilitation services via digital technologies, is an innovative approach that may overcome some of these barriers. It offers the potential to increase access to care, reduce costs, and improve adherence and outcomes in patients with knee OA [ 16 , 17 ]. Evidence indicates that telerehabilitation can be as effective as in-person or office-based rehabilitation in reducing pain and improving function [ 18 , 19 ], with added advantages of flexibility, time saving, and convenience [ 20 ]. A recent systematic review further suggests that telerehabilitation may achieve comparable results to conventional rehabilitation [ 21 ]. Nevertheless, existing studies are heterogeneous with respect to intervention protocols, duration, outcome measures, and follow-up, making it difficult to draw firm conclusions regarding its clinical effectiveness and sustainability [ 22 ]. Moreover, few randomised controlled trials have comprehensively assessed patient-centred outcomes such as adherence, satisfaction, and health-related quality of life, which are crucial for long-term management and successful implementation [ 23 ]. Therefore, there is a clear need for rigorously designed randomised controlled trials directly comparing structured telerehabilitation with unsupervised home exercise, while simultaneously addressing patient-centred outcomes such as adherence, satisfaction, and quality of life. Objectives {7} The primary objective of this study is to evaluate the effectiveness of a three-month telerehabilitation programme compared with unsupervised home exercise in improving knee function in patients with knee OA. Secondary objectives are to 1) assess differences in pain, stiffness, mobility, and physical activity levels between groups; 2) evaluate changes in health-related quality of life; 3) measure exercise adherence and identify reasons for reduced adherence; 4) assess patient satisfaction with telerehabilitation. Trial design {8} This study is a single-centre, parallel-group randomised controlled trial (RCT) designed to compare the effectiveness of the telerehabilitation (TR) approach with the unsupervised exercise (UE) approach in patients with knee osteoarthritis. Methods: Participants, interventions and outcomes Study setting {9} The trial will be conducted at the Artros Medical Centre in Ljubljana, Slovenia, a specialized orthopaedic outpatient clinic providing advanced diagnostic and rehabilitation services for patients with musculoskeletal disorders, including knee osteoarthritis. This centre represents a typical secondary care setting where patients with knee OA receive evaluation, treatment, and follow-up rehabilitation. Data will be collected exclusively in Slovenia. Detailed information about the participating study site(s) and their characteristics is available upon request from the corresponding author. Eligibility criteria {10} For each potential participant, eligibility for the trial will be assessed and confirmed by a medically qualified practitioner at the Artros Medical Centre. Inclusion criteria Patients with symptomatic OA of the knee joint, graded 1-3 on the Kellgren-Lawrence scale Patients older than 50 years Patients with access to and proficiency in using a computer, Patients with the capability to follow the exercises outlined. Exclusion criteria Grade 4 cartilage defect (cartilage defect up to the subchondral bone), for which surgical treatment is professionally indicated, Planned arthroplasty of the knee joint within the next 6 months, Patients who have had a previous TEP arthroplasty or partial knee arthroplasty (hereafter PEP), Patients with a history of trauma or surgical treatment of the knee joint (osteotomy or treatment of cartilage lesions) in the last 6 months, Patients who have received an intra-articular injection in the knee joint in the last 3 months, Patients who have systemic inflammatory arthritis (e.g. Rheumatoid arthritis or gout) or those who have concomitant medical conditions that prevent participation in exercise, Patients who have cognitive impairments or are wheelchair users, Who have co-morbidities, Those who do not have access to a computer have limited language skills that prevent the correct use of telerehabilitation or Those who are involved in a similar study. Who will take informed consent? {26a} It is the responsibility of the Principal Investigator at the Artros Medical Centre to obtain written informed consent from each participant prior to the initiation of any study-related procedures, including eligibility screening and baseline assessments. Additional consent provisions for collection and use of participant data and biological specimens {26b} As part of the informed consent process, participants will be asked to provide additional consent for the collection, use, and storage of their study data for research purposes. This will include permission for the use of anonymised clinical and outcome data collected during the trial for secondary analyses and publication in scientific journals. Interventions Explanation for the choice of comparators {6b} All patients diagnosed with knee OA who present at Artros Medical Centre for an orthopaedic specialist consultation will undergo a radiological examination. Based on the radiographic findings and clinical evaluation, the orthopaedic specialist will refer eligible patients to a physiotherapist, who will assign them to the TR or UE group. The physiotherapist will provide both verbal and written explanations of the study procedures. Patients will be included in the study after providing written informed consent. Intervention description {11a} The physiotherapist will collect baseline data, including: Sociodemographic characteristics, Anthropometric measurements: height (cm), weight (kg), body mass index (BMI) (kg/m²), Educational background and employment status, Knee joint mobility assessment using a goniometer, Pain intensity measurement using the Numerical Rating Scale (NRS), Physical function, stiffness, and pain assessment using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Physical activity evaluation using the International Physical Activity Questionnaire (IPAQ), Health-related quality of life assessment using the 12-Item Short Form Health Survey (SF-12), OA severity classification based on recent knee radiographs (≤ 4 months old), graded using the Kellgren-Lawrence classification system. Criteria for discontinuing or modifying allocated interventions {11b} All participants may withdraw from the study at any stage without any negative consequences. Participants expressing the need for psychological support will be referred by the investigators to appropriate clinical services. Strategies to improve adherence to interventions {11c} To enhance adherence to the assigned intervention, participants in the telerehabilitation group will receive regular feedback and individual support from the supervising physiotherapist, who will address any questions or difficulties encountered during the programme. Participants in both groups will be encouraged to maintain exercise logs and will receive periodic reminders to support consistent engagement throughout the study period. Relevant concomitant care permitted or prohibited during the trial {11d} Participants who are receiving other forms of structured physiotherapy or supervised exercise programmes for knee osteoarthritis will not be eligible to participate in the trial. Any initiation of new rehabilitation or exercise interventions during the trial will not be allowed. Provisions for post-trial care {30} We do not expect the intervention to pose any risk of harm to participants. Outcomes {12} The primary outcome will be the change in knee function, measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score after 3 months of intervention compared with baseline. The secondary outcomes will include: Pain intensity, assessed with the 11-point Numerical Rating Scale (NRS). Knee joint mobility, measured with a goniometer. Physical activity levels assessed using the International Physical Activity Questionnaire (IPAQ). Health-related quality of life, assessed with the 12-Item Short Form Health Survey (SF-12). Exercise adherence and frequency, recorded via exercise diaries (control group) and digital communication logs (telerehabilitation group). Patient satisfaction with telerehabilitation, assessed with a 5-point Likert scale questionnaire. Reasons for reduced adherence or discontinuation of exercise, assessed via structured self-report questionnaires. Randomisation will be performed in a 1:1 ratio using a computer-generated random sequence prepared by an independent statistician not otherwise involved in patient recruitment or outcome assessment. Allocation concealment will be ensured through sealed, opaque, sequentially numbered envelopes. The envelopes will be opened only after baseline assessment, at which point the physiotherapist will assign the patient to either the telerehabilitation or control group. Questionnaires used to assess outcomes Sociodemographic variables , namely sex, age (years), and anthropometric variables, body height (centimetres) and body weight (kilograms) for the calculation of BMI (calculated as weight in kilograms divided by height in metres squared), education, and current employment status. Assessing mobility : A goniometer, a key component of the musculoskeletal examination, will be used to assess mobility. It documents the initial and subsequent range of motion [24]. Pain intensity assessment : To assess the intensity of the pain, we will use an 11-point Numerical Rating Scale (NRS), where 0 means no pain, and 10 represents the worst pain you can imagine. Pain assessment is an integral part of evaluating and monitoring your treatment. Pain intensity is probably the most crucial information about a patient's experience of pain [8], regardless of disability or disease. The NRS can be used to assess the intensity of current pain, usual (average) pain, worst pain or least severe pain over a given period, which should be clearly stated in the instructions and recorded alongside the score. The numbers should be written in ascending order from 0 to 10 from left to right, and both thresholds should be described [25]. Patients will be presented with the scale and will be told an integer number representing the rating of their pain intensity. Physical function, stiffness and pain : We will use the WOMAC pain scale to measure physical function, stiffness and pain. The scale is used to assess pain, stiffness and physical function in patients with OA of the knee joint. It was developed in 1982 by Nicolas Bellamy. It was initially designed to assess the treatment outcome in patients with rheumatoid arthritis but was later validated to evaluate hip and knee joint function. It is divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each item is rated on a Likert scale from 0 to 4 [8, 26] with a total score of 96. The lower the score, the better the functional status and the less pain. A score above 39 points indicates a worse functional status due to advanced wear changes. With the WOMAC scale, Soderman and Malchau confirmed a good association between pain and physical function [27]. The WOMAC is valid, reliable and responsive in several OA studies [28]. Physical activity assessment The International Physical Activity Questionnaire (IPAQ) will be used to assess physical activity. The IPAQ was developed by the World Health Organisation in 1998 to monitor physical activity and facilitate global comparisons [29]. It consists of 7 items and is widely used to measure physical activity levels [30]. Open-ended questions refer to the number of days and time spent in moderate-intensity, vigorous-intensity and walking physical activity lasting at least 10 minutes in the last 7 days. It also includes time spent sitting in the previous 7 days [31]. It allows the calculation of the metabolic equivalent (MET) by measuring the frequency, duration and intensity level of physical activity in the last 7 days. It represents the amount of physical activity per week. It is calculated as weekly work hours (MET-hours/week) [32]. 12-Item Short Form Health Survey Health-related quality of life assessment is essential to managing patients with chronic diseases [33]; we will use the SF-12 (Short Form 12), a general health questionnaire. It is a multipurpose general health measurement in short form, developed in 1995 by Ware, Kosinski and Keller (1995, p. 11) [34]. It allows for health status statements on eight dimensions [35] of patients with chronic conditions [36]. The SF-12 is a reliable measure and one of the most used instruments for assessing self-reported health-related quality of life [37]. Webster and Feller [38] confirmed in their study that the questionnaire is comparable to the more extended version of the SF-36 for measuring health-related quality of life over time in patients with knee OA. Assessing improvements in knee joint function, mobility, and health-related quality of life : We will use existing scales to evaluate improvements in knee joint function, mobility and health-related quality of life, which we have adapted to our needs because we want to determine the impact of the outcomes of the telerehabilitation programme on the satisfaction of patients with OA of the knee joint. Patients will respond according to a 5-point Likert scale assessing mobility [39, 40], pain [41], stiffness, physical activity [25] and health-related quality of life [37]. Satisfaction rating Patients will answer a 5-point Likert scale to assess their satisfaction with telerehabilitation using a web-based exercise app to increase knee joint mobility and strengthen muscles. They will rate the quality of the service, answering whether they received the service they wanted, whether the service fully met their needs, whether they would recommend the service to a friend, whether the service helped them improve knee joint function, mobility and health-related quality of life, whether they have seen much improvement since starting the exercise, whether they are satisfied with the service, and if they need similar services in the future, whether they would use the service again [13, 32, 42]. Measuring the reasons for reducing the frequency of exercise or discontinuing telerehabilitation To measure the reasons for reducing the frequency of exercise or discontinuing telerehabilitation, patients with knee OA undergoing telerehabilitation will respond to a 5-point Likert scale on whether they had technical problems, communication problems, problems with the content of the telerehabilitation itself, or whether they may have reduced or even discontinued telerehabilitation due to personal circumstances [43]. Assessing the benefits of using telerehabilitation Patients with OA of the knee joint undergoing telerehabilitation will rate the benefits of using telerehabilitation. They will respond on a 5-point Likert scale to 11 items on timesaving, money-saving, increased autonomy motivation, comfort, easier access to a physiotherapist(s), easier communication with a physiotherapist(s), and accuracy/veracity of information when using telerehabilitation. They will also assess the effectiveness of the exercise, give an opinion on the possibility of seeing the exercises multiple times and assess the ease of use of telerehabilitation [44]. Sample size {14} The sample size was calculated based on the study results Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial [41] using G*Power software version 3.1 [45]. To calculate the sample size, we used the results of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. The alpha error probability was set at 0.05, the 1-beta error probability was set at 0.80, and the effect size was taken from the study (0.288). A sample size of 74 subjects was calculated. Considering the expected % dropout rate of 15%, 85 subjects should be randomised, 43 in each group. To increase statistical power and ensure robustness, we will enrol 120 patients (60 per group). Recruitment {15} All patients diagnosed with knee OA who present at Artros Medical Centre for an orthopaedic specialist consultation will undergo a radiological examination. Based on the radiographic findings and clinical evaluation, the orthopaedic specialist will refer eligible patients to a physiotherapist, who will assign them to the TR or UE group. The physiotherapist will provide both verbal and written explanations of the study procedures. Patients will be included in the study after providing written informed consent. Assignment of interventions: allocation Sequence generation {16a} After participant and partner selection, we will allocate participants to intervention and control groups in a 1:1 ratio. Concealment mechanism {16b} Randomization will be performed by an external person not involved in the study. Implementation {16c} The physiotherapist will collect baseline data, including: Sociodemographic characteristics, Anthropometric measurements: height (cm), weight (kg), body mass index (BMI) (kg/m²), Educational background and employment status, Knee joint mobility assessment using a goniometer, Pain intensity measurement using the Numerical Rating Scale (NRS), Physical function, stiffness, and pain assessment using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Physical activity evaluation using the International Physical Activity Questionnaire (IPAQ), Health-related quality of life assessment using the 12-Item Short Form Health Survey (SF-12), OA severity classification based on recent knee radiographs (≤ 4 months old), graded using the Kellgren-Lawrence classification system. Assignment of interventions: Blinding Who will be blinded {17a} Given the nature of the intervention, neither patients nor physiotherapists can be blinded to group allocation. However, the orthopaedic specialists performing clinical examinations and the research staff conducting outcome analyses will remain blinded. This blinding strategy reduces the risk of detection and assessment bias. Unblinding will be permitted only in the event of a serious adverse event that requires disclosure. Procedure for unblinding if needed {17b} Not relevant. Data collection and management Plans for assessment and collection of outcomes {18a} Upon enrolment, patients will receive detailed physiotherapeutic instructions. The rehabilitation protocol will be identical for both the TR and UE groups and will comprise: Targeted strengthening exercises for the core and lower limb musculature Mobility exercises for the hip, knee, and ankle joints Balance and stabilisation exercises The intervention is designed to be performed without external equipment, relying solely on body weight resistance exercises. Each session will last approximately 20–25 minutes, and patients will be instructed to complete the exercises three times per week, with a minimum interval of 24 hours and a maximum of 72 hours between sessions. Tele-Rehabilitation Group Patients in the TR group will have access to continuous remote support from the physiotherapist, including: Weekly scheduled phone consultations Live virtual consultations via MS Teams, Zoom, or Skype Text messages and emails for personalised guidance, motivation, and troubleshooting Unsupervised Exercise Group Patients in the UE group will receive only written exercise instructions and perform the rehabilitation programme independently at home without additional remote supervision. Midway Evaluation and Adherence Monitoring As a motivational strategy, the physiotherapist will check in with patients in the UE group at the midpoint of the intervention period to assess adherence and potential barriers to exercise compliance. This midterm contact aims to identify and address patient-specific challenges and enhance adherence to the rehabilitation protocol. Plans to promote participant retention and complete follow-up {18b} At three months post-intervention, the physiotherapist will conduct a follow-up evaluation, collecting additional data on Exercise adherence and frequency, Potential reasons for reduced exercise engagement or discontinuation of TR, and Patient-perceived benefits of the TR approach. After the intervention, all patients will undergo a final clinical assessment with the orthopaedic specialist. The physiotherapist will reassess joint mobility using a goniometer, and patients will complete standardised questionnaires evaluating Pain intensity (NRS), Knee function (WOMAC Index), Physical activity (IPAQ), Health-related quality of life (SF-12) and Overall satisfaction with the TR approach. Additionally, patients will report reasons for potential reductions in exercise frequency or discontinuation and provide qualitative feedback on the TR approach's advantages and limitations. Data management {19} The corresponding author, responsible for the data's confidentiality, will collect and store all data on paper. The project leader will print all questionnaires and have the patients complete them. The corresponding author will enter the data into anonymised tables, which will then be used for statistical processing. SPSS software will be used for statistical analysis. Confidentiality {27} Before any statistical analysis, the data will be tested for normal distribution using the Kolmogorov-Smirnov (K-S) test. A t-test for independent samples will be used to determine the difference in patients with OA of the knee joint in terms of improvement in mobility, pain reduction and quality of life between the UE and the UE group who will exercise alone. A t-test for dependent samples will be used to determine the difference in knee joint function scores in patients with OA of the knee joint and the difference in physical activity of patients at the end of TS in UE compared to baseline. Multiple linear regression will be used to determine the impact of the outcomes of the UE programme (mobility, pain, stiffness, physical activity, health-related quality of life) on patients' satisfaction with telerehabilitation. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} Not applicable. Statistical methods Statistical methods for primary and secondary outcomes {20a} The statistical analysis will follow the intention-to-treat (ITT) principle, including all randomised participants in the groups to which they were assigned, regardless of adherence. Missing data will be addressed using multiple imputation techniques, and sensitivity analyses will be conducted to test the robustness of the findings. Imputation models will include baseline characteristics and all outcome variables. Interim analyses {21b} There is no plan for any interim analysis or stopping data collection. Methods for additional analyses (e.g. subgroup analyses) {20b} There are no planned subgroup analyses for the primary or secondary outcomes. Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} This clinical trial aims to evaluate the effectiveness of the intervention under conditions that closely resemble real-world practice. It will therefore not be possible to fully eliminate the potential influence of confounding or modifying variables, such as concomitant treatments, participant withdrawal, or partial non-adherence to the intervention. For this reason, an intention-to-treat analysis has been chosen. Plans to give access to the full protocol, participant level-data and statistical code {31c} The complete study protocol, anonymised participant-level dataset, and statistical code will be available from the corresponding author upon reasonable request after publication of the main results. Data sharing will comply with the study’s ethical approval and relevant data protection legislation. Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} The study will be coordinated by the Faculty of Health, University of Novo Mesto, in collaboration with the Artros Medical Centre. The coordinating centre will supervise all study procedures, including recruitment, data management, and quality assurance. The trial steering committee, composed of the principal investigator, project supervisor, and collaborating researchers, will meet regularly—at least once per month—to review study progress, ensure adherence to the protocol, and resolve any procedural issues. Composition of the data monitoring committee, its role and reporting structure {21a} We do not intend to establish a data oversight committee, as this is a low-risk intervention. We have submitted ethical reports to the Slovenian Medical Ethics Committee and ensured that all steps of the study follow the best standards of care. Adverse event reporting and harms {22} All adverse or unintended effects will be promptly reported to the principal investigator, who will be responsible for their assessment, management, and, when appropriate, referral of participants to relevant clinical services. Frequency and plans for auditing trial conduct {23} Monthly meetings are expected to be held with at least the principal investigator and project supervisor present; whenever possible, trial audits will involve all investigators, either online or in person. Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} Any amendments to the study or protocol will be communicated to all investigators and the ethics committee. Dissemination plans {31a} Study results will be published in peer-reviewed journals and presented at scientific conferences. Discussion The present study protocol describes a randomised controlled trial evaluating the effectiveness of a structured telerehabilitation programme compared with unsupervised home-based exercise in patients with knee osteoarthritis. This trial addresses an important evidence gap by systematically assessing both clinical outcomes and patient-reported measures such as adherence, satisfaction, and quality of life. Strengths of the study design include the randomised controlled design, use of validated outcome measures (WOMAC, NRS, IPAQ, SF-12), and standardized intervention protocols applied across both groups. The incorporation of patient-centered outcomes, such as satisfaction and reasons for discontinuation, will provide additional insights into the feasibility and acceptability of telerehabilitation. Furthermore, the relatively large sample size will increase statistical power and the generalizability of the findings. Limitations should also be acknowledged. Due to the nature of the intervention, participants and physiotherapists cannot be blinded, which may introduce performance bias. Although outcome assessors will remain blinded, some risk of detection bias cannot be completely eliminated. Another limitation is the single-centre design, which may reduce external validity across different healthcare systems and cultural contexts. Moreover, the study duration of three months may not capture the long-term sustainability of telerehabilitation effects. Potential challenges during implementation include variability in patient adherence to exercise protocols, technological barriers such as limited digital literacy or unstable internet connections, and motivational issues among patients exercising without direct supervision. These challenges will be mitigated through regular remote support in the telerehabilitation group and midterm adherence checks in the control group; however, some degree of non-adherence is expected. Implications for clinical practice and health policy are substantial. If telerehabilitation proves to be effective, feasible, and acceptable, it may serve as a cost-effective and scalable complement to traditional rehabilitation, particularly in regions with limited access to physiotherapy services. The findings could inform the integration of digital health strategies into routine osteoarthritis management, improve patient-centered care, and potentially reduce healthcare costs related to disability and joint replacement surgery. Moreover, results may guide policymakers in developing reimbursement models and infrastructure investments to support the broader use of telerehabilitation. In addition, the evidence generated may contribute to future European and international guidelines for the management and rehabilitation of knee osteoarthritis. Future directions The primary aim of this study is to evaluate the effectiveness of a three-month telerehabilitation exercise programme in improving knee joint mobility, reducing pain, and enhancing overall function in patients with knee OA, compared to those performing exercises independently. The study will focus on assessing changes in pain, stiffness, and physical function of the knee joint, as well as the impact of telerehabilitation on patients' physical activity levels and overall quality of life. Additionally, patient satisfaction with telerehabilitation will be analysed, including improved knee function, mobility, and health-related quality of life. Future research should explore the long-term effects of telerehabilitation on knee OA management, assessing whether the benefits observed in mobility, pain reduction, and quality of life are sustained beyond the intervention period. Further studies could also investigate the cost-effectiveness of telerehabilitation compared to traditional rehabilitation and its potential for integration into routine clinical practice. Expanding the study to include a more extensive and more diverse patient population and evaluating different telerehabilitation modalities could provide deeper insights into optimising remote rehabilitation strategies for OA and other musculoskeletal conditions. Trial status Patient recruitment for our study started in September 2025 at the Artros Orthopaedic Centre. The estimated time of recruitment completion is November 2025. Abbreviations OA: osteoarthritis; unsupervised exercise (UE); UE control group; SF-36: 36-Item Short Form Health Survey; SF12: 12-Item Short Form Survey, IPAQ: International Physical Activity Questionnaire, WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index, MET: metabolic equivalent; NRS: 11-point Numerical Rating Scale; BMI: Body mass index; TEP: total endoprosthesis; PEP: partial endoprosthesis Declarations Acknowledgements The authors sincerely thank the physiotherapists for conducting all physical tests and for their support in implementing the study. Authors’ contributions {31b} All three authors contributed to the formation of the study protocol. PK and KE prepared the training protocol for the intervention group and provided outcome measures. PK and MH adjusted the new training protocol for clinical use. All together, we planned the timeline and safety protocols. PK collected all the data from previous studies and transferred new ideas to the comprehensive study protocol. KE and MH developed the protocol. The authors read and approved the final manuscript. Funding {4} The Slovenian Research and Innovation Agency and Artros d.o.o. [grant number L7-50184] supported this work. Availability of data and materials {29} The data supporting this study's findings are available on request from the corresponding author. Ethics approval and consent to participate {24} Ethical approval for this study was obtained from the National Committee on Medical Ethics of the Republic of Slovenia (No. 0120–471/2023-2711-4). Informed consent to participate was obtained from all individual participants. Consent for publication {32} Not applicable. This manuscript does not contain any person’s data in any form (including individual details, images, or videos) that would require consent for publication. Competing interests {28} The authors declare no competing interests. Authors’ information (optional) 1,2 Faculty of Health, University of Novo Mesto, Novo Mesto, Slovenia 3 Artros d.o.o, Tehnološki park 19, Ljubljana, 1000, Slovenia References Dhillon MS, Patel S, John R. PRP in OA knee - update, current confusions and future options. SICOT J. 2017;3:27. doi:10.1051/sicotj/2017004 Moutzouri M, Koumantakis GA, Hurley M, Kladouchou AG, Gioftsos G. Effectiveness of a web-guided self-managed telerehabilitation enhanced with outdoor physical activity on physical function, physical activity levels and pain in patients with knee osteoarthritis: a controlled trial. J Clin Med. 2024;13(4):934. doi:10.3390/jcm13040934 Pinto Barbosa S, Marques L, Sugawara A, Toledo F, Imamura M, Battistella L, Simis M, Fregni F. Predictors of the health-related quality of life (HRQOL) in SF-36 in knee osteoarthritis patients: a multimodal model with moderators and mediators. 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SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi:10.1136/bmj.e7586 Schön C, Reule C, Knaub K, Micka A, Wilhelm M, Alt W, Menzel D. Evaluation and validation of a joint stress test to induce activity-related knee joint discomfort - a prospective case-control study. Sports Med Open. 2021;7:24. doi:10.1186/s40798-021-00317-7 Hinman RS, Campbell PK, Lawford BJ, Briggs AM, Gale J, Bills C, Kasza J, Harris A, French SD, Bunker SJ, Forbes A, Bennell KL. Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial. Br J Sports Med. 2020;54(13):790–797. doi:10.1136/bjsports-2019-101183 Pedersen H, Skliarova T, Attkisson CC, Lara-Cabrera ML, Havnen A. Measuring patient satisfaction with four items: validity of the client satisfaction questionnaire 4 in an outpatient population. BMC Psychiatry. 2023;23:808. doi:10.1186/s12888-023-05310-w Ouédraogo F, Auger LP, Moreau E, Côté O, Guerrera R, Rochette A, Kairy D. Acceptability of telerehabilitation: experiences and perceptions by individuals with stroke and caregivers in an early supported discharge. Healthcare (Basel). 2024;12(3):365. doi:10.3390/healthcare12030365 Chivate S, Sharma M, Shaikh A, Satarkar C. Benefits and challenges of telerehabilitation use by pediatric physiotherapists during the COVID-19 pandemic in Western and Southern India: a cross-sectional survey. Int J Telerehabil. 2022;14(1):e6466. doi:10.5195/ijt.2022.6466 Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009;41(4):1149–1160. doi:10.3758/BRM.41.4.1149 Cite Share Download PDF Status: Under Revision Version 1 posted Reviewers agreed at journal 21 Jan, 2026 Reviewers invited by journal 09 Jan, 2026 Editor assigned by journal 17 Nov, 2025 First submitted to journal 13 Nov, 2025 Editorial decision: Major revision 08 Nov, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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cellpadding=\\\"0\\\" width=\\\"639\\\"\\u003e\\n \\u003ctbody\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 218px;\\\"\\u003e\\n \\u003cp\\u003eTitle {1}\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 421px;\\\"\\u003e\\n \\u003cp\\u003eTelerehabilitation compared with unsupervised home exercise for knee osteoarthritis: study protocol for a single-centre, parallel-group randomised controlled trial\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 218px;\\\"\\u003e\\n \\u003cp\\u003eTrial registration {2a and 2b}.\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 421px;\\\"\\u003e\\n \\u003cp\\u003eClinicalTrials.gov NCT07137897\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 218px;\\\"\\u003e\\n \\u003cp\\u003eProtocol version {3}\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 421px;\\\"\\u003e\\n \\u003cp\\u003eUnique Protocol IdL7-50184\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 218px;\\\"\\u003e\\n \\u003cp\\u003eFunding {4}\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 421px;\\\"\\u003e\\n \\u003cp\\u003eThe Slovenian Research and Innovation Agency and Artros d.o.o. [grant number L7-50184] supported this work\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 218px;\\\"\\u003e\\n \\u003cp\\u003eAuthor details {5a}\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 421px;\\\"\\u003e\\n \\u003cp\\u003ePetra Kotnik,\\u0026nbsp;Faculty of Health, University of Novo Mesto, Novo Mesto, Slovenia,\\u0026nbsp;petra.kotnik@uni-nm.si\\u0026nbsp;\\u003c/p\\u003e\\n \\u003cp\\u003eKarmen Erjavec,\\u0026nbsp;Faculty of Health, University of Novo Mesto, Novo Mesto, Slovenia,\\u0026nbsp;karmen.erjavec@uni-nm.si\\u003c/p\\u003e\\n \\u003cp\\u003eMohsen Hussein,\\u0026nbsp;Artros d.o.o, Tehnolo\\u0026scaron;ki park 19, Ljubljana, 1000, Slovenia; mhussein@artros.si\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 218px;\\\"\\u003e\\n \\u003cp\\u003eName and contact information for the trial sponsor {5b}\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 421px;\\\"\\u003e\\n \\u003cp\\u003eApplied research project ARIS - Public Agency for Science, Research and Innovation of the Republic of Slovenia and co-financed by Artros, d.o.o\\u003c/p\\u003e\\n \\u003cp\\u003eProject leader and Contact person: Prof. Dr. Karmen Erjavec, karmen.erjavec@uni-nm.si\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003ctr\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 218px;\\\"\\u003e\\n \\u003cp\\u003eRole of sponsor {5c}\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003ctd valign=\\\"top\\\" style=\\\"width: 421px;\\\"\\u003e\\n \\u003cp\\u003eThe co-founder had a partial role in the study design, data collection, management, analysis, and interpretation, as well as in the preparation of the study report. The authors had full access to all data and take full responsibility for the integrity of the data and the accuracy of the data analysis. The final decision to submit the manuscript for publication was made independently by the authors.\\u003c/p\\u003e\\n \\u003c/td\\u003e\\n \\u003c/tr\\u003e\\n \\u003c/tbody\\u003e\\n\\u003c/table\\u003e\"},{\"header\":\"Introduction\",\"content\":\"\\n\\u003ch3\\u003eBackground and rationale {6a}\\u003c/h3\\u003e\\n\\u003cp\\u003eKnee osteoarthritis (OA) is among the most common chronic musculoskeletal disorders and a leading cause of disability worldwide [\\u003cspan citationid=\\\"CR1\\\" class=\\\"CitationRef\\\"\\u003e1\\u003c/span\\u003e]. Its global prevalence is approximately 23% in adults over the age of 40 [\\u003cspan citationid=\\\"CR2\\\" class=\\\"CitationRef\\\"\\u003e2\\u003c/span\\u003e] and continues to rise due to demographic ageing, increased life expectancy, obesity, and the absence of disease-modifying pharmacological therapies [\\u003cspan additionalcitationids=\\\"CR4\\\" citationid=\\\"CR3\\\" class=\\\"CitationRef\\\"\\u003e3\\u003c/span\\u003e\\u0026ndash;\\u003cspan citationid=\\\"CR5\\\" class=\\\"CitationRef\\\"\\u003e5\\u003c/span\\u003e]. OA of the knee joint is particularly burdensome, contributing not only to pain, stiffness, inflammation and reduced mobility but also to significant limitations in independence, productivity and quality of life [\\u003cspan citationid=\\\"CR6\\\" class=\\\"CitationRef\\\"\\u003e6\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR7\\\" class=\\\"CitationRef\\\"\\u003e7\\u003c/span\\u003e]. The societal and economic impact is substantial, with OA ranking as one of the most common causes of long-term disability and accounting for a considerable share of health service costs [\\u003cspan citationid=\\\"CR8\\\" class=\\\"CitationRef\\\"\\u003e8\\u003c/span\\u003e]. Direct costs include surgery, pharmacotherapy, and healthcare utilisation, while indirect consequences such as work absenteeism, early retirement, and increased cardiovascular risk due to inactivity further add to its burden [\\u003cspan citationid=\\\"CR9\\\" class=\\\"CitationRef\\\"\\u003e9\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eSelf-management, especially exercise therapy, remains the cornerstone of non-pharmacological treatment for knee OA [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e]. Regular physical activity has been shown to alleviate symptoms, enhance joint mobility and improve health-related quality of life [\\u003cspan citationid=\\\"CR11\\\" class=\\\"CitationRef\\\"\\u003e11\\u003c/span\\u003e]. The World Health Organization recommends at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity weekly for adults, including older adults [\\u003cspan citationid=\\\"CR12\\\" class=\\\"CitationRef\\\"\\u003e12\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e]. Despite these guidelines, adherence to unsupervised home-based exercise programmes is frequently poor [\\u003cspan citationid=\\\"CR14\\\" class=\\\"CitationRef\\\"\\u003e14\\u003c/span\\u003e], and patients often face barriers related to motivation, pain, and limited professional support [\\u003cspan citationid=\\\"CR15\\\" class=\\\"CitationRef\\\"\\u003e15\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eTelerehabilitation, defined as the remote delivery of rehabilitation services via digital technologies, is an innovative approach that may overcome some of these barriers. It offers the potential to increase access to care, reduce costs, and improve adherence and outcomes in patients with knee OA [\\u003cspan citationid=\\\"CR16\\\" class=\\\"CitationRef\\\"\\u003e16\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR17\\\" class=\\\"CitationRef\\\"\\u003e17\\u003c/span\\u003e]. Evidence indicates that telerehabilitation can be as effective as in-person or office-based rehabilitation in reducing pain and improving function [\\u003cspan citationid=\\\"CR18\\\" class=\\\"CitationRef\\\"\\u003e18\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR19\\\" class=\\\"CitationRef\\\"\\u003e19\\u003c/span\\u003e], with added advantages of flexibility, time saving, and convenience [\\u003cspan citationid=\\\"CR20\\\" class=\\\"CitationRef\\\"\\u003e20\\u003c/span\\u003e]. A recent systematic review further suggests that telerehabilitation may achieve comparable results to conventional rehabilitation [\\u003cspan citationid=\\\"CR21\\\" class=\\\"CitationRef\\\"\\u003e21\\u003c/span\\u003e]. Nevertheless, existing studies are heterogeneous with respect to intervention protocols, duration, outcome measures, and follow-up, making it difficult to draw firm conclusions regarding its clinical effectiveness and sustainability [\\u003cspan citationid=\\\"CR22\\\" class=\\\"CitationRef\\\"\\u003e22\\u003c/span\\u003e]. Moreover, few randomised controlled trials have comprehensively assessed patient-centred outcomes such as adherence, satisfaction, and health-related quality of life, which are crucial for long-term management and successful implementation [\\u003cspan citationid=\\\"CR23\\\" class=\\\"CitationRef\\\"\\u003e23\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eTherefore, there is a clear need for rigorously designed randomised controlled trials directly comparing structured telerehabilitation with unsupervised home exercise, while simultaneously addressing patient-centred outcomes such as adherence, satisfaction, and quality of life.\\u003c/p\\u003e\\n\\u003ch3\\u003eObjectives {7}\\u003c/h3\\u003e\\n\\u003cp\\u003eThe primary objective of this study is to evaluate the effectiveness of a three-month telerehabilitation programme compared with unsupervised home exercise in improving knee function in patients with knee OA.\\u003c/p\\u003e \\u003cp\\u003eSecondary objectives are to 1) assess differences in pain, stiffness, mobility, and physical activity levels between groups; 2) evaluate changes in health-related quality of life; 3) measure exercise adherence and identify reasons for reduced adherence; 4) assess patient satisfaction with telerehabilitation.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec3\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eTrial design {8}\\u003c/h2\\u003e \\u003cp\\u003eThis study is a single-centre, parallel-group randomised controlled trial (RCT) designed to compare the effectiveness of the telerehabilitation (TR) approach with the unsupervised exercise (UE) approach in patients with knee osteoarthritis.\\u003c/p\\u003e \\u003c/div\\u003e\"},{\"header\":\"Methods: Participants, interventions and outcomes\",\"content\":\"\\u003cp\\u003e\\u003cstrong\\u003eStudy setting {9}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe trial will be conducted at the Artros Medical Centre in Ljubljana, Slovenia, a specialized orthopaedic outpatient clinic providing advanced diagnostic and rehabilitation services for patients with musculoskeletal disorders, including knee osteoarthritis. This centre represents a typical secondary care setting where patients with knee OA receive evaluation, treatment, and follow-up rehabilitation.\\u003c/p\\u003e\\n\\u003cp\\u003eData will be collected exclusively in Slovenia. Detailed information about the participating study site(s) and their characteristics is available upon request from the corresponding author.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eEligibility criteria {10}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eFor each potential participant, eligibility for the trial will be assessed and confirmed by a medically qualified practitioner at the Artros Medical Centre.\\u003c/p\\u003e\\n\\u003cp\\u003eInclusion criteria\\u003c/p\\u003e\\n\\u003cul\\u003e\\n \\u003cli\\u003ePatients with symptomatic OA of the knee joint, graded 1-3 on the Kellgren-Lawrence scale\\u003c/li\\u003e\\n \\u003cli\\u003ePatients older than 50 years\\u003c/li\\u003e\\n \\u003cli\\u003ePatients with access to and proficiency in using a computer,\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003ePatients with the capability to follow the exercises outlined.\\u003c/li\\u003e\\n\\u003c/ul\\u003e\\n\\u003cp\\u003eExclusion criteria\\u003c/p\\u003e\\n\\u003cul\\u003e\\n \\u003cli\\u003eGrade 4 cartilage defect (cartilage defect up to the subchondral bone), for which surgical treatment is professionally indicated,\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003ePlanned arthroplasty of the knee joint within the next 6 months,\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003ePatients who have had a previous TEP arthroplasty or partial knee arthroplasty (hereafter PEP),\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003ePatients with a history of trauma or surgical treatment of the knee joint (osteotomy or treatment of cartilage lesions) in the last 6 months,\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003ePatients who have received an intra-articular injection in the knee joint in the last 3 months,\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003ePatients who have systemic inflammatory arthritis (e.g. Rheumatoid arthritis or gout) or those who have concomitant medical conditions that prevent participation in exercise,\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003ePatients who have cognitive impairments or are wheelchair users,\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003eWho have co-morbidities,\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003eThose who do not have access to a computer have limited language skills that prevent the correct use of telerehabilitation or\\u0026nbsp;\\u003c/li\\u003e\\n \\u003cli\\u003eThose who are involved in a similar study.\\u003c/li\\u003e\\n\\u003c/ul\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eWho will take informed consent? {26a}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eIt is the responsibility of the Principal Investigator at the Artros Medical Centre to obtain written informed consent from each participant prior to the initiation of any study-related procedures, including eligibility screening and baseline assessments.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAdditional consent provisions for collection and use of participant data and biological specimens {26b}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAs part of the informed consent process, participants will be asked to provide additional consent for the collection, use, and storage of their study data for research purposes. This will include permission for the use of anonymised clinical and outcome data collected during the trial for secondary analyses and publication in scientific journals.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eInterventions\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eExplanation for the choice of comparators {6b}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAll patients diagnosed with knee OA who present at Artros Medical Centre for an orthopaedic specialist consultation will undergo a radiological examination. Based on the radiographic findings and clinical evaluation, the orthopaedic specialist will refer eligible patients to a physiotherapist, who will assign them to the TR or UE group. The physiotherapist will provide both verbal and written explanations of the study procedures. Patients will be included in the study after providing written informed consent.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eIntervention description {11a}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe physiotherapist will collect baseline data, including: Sociodemographic characteristics, Anthropometric measurements: height (cm), weight (kg), body mass index (BMI) (kg/m\\u0026sup2;), Educational background and employment status, Knee joint mobility assessment using a goniometer, Pain intensity measurement using the Numerical Rating Scale (NRS), Physical function, stiffness, and pain assessment using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Physical activity evaluation using the International Physical Activity Questionnaire (IPAQ), Health-related quality of life assessment using the 12-Item Short Form Health Survey (SF-12), OA severity classification based on recent knee radiographs (\\u0026le; 4 months old), graded using the Kellgren-Lawrence classification system.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eCriteria for discontinuing or modifying allocated interventions {11b}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAll participants may withdraw from the study at any stage without any negative consequences. Participants expressing the need for psychological support will be referred by the investigators to appropriate clinical services.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eStrategies to improve adherence to interventions {11c}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eTo enhance adherence to the assigned intervention, participants in the telerehabilitation group will receive regular feedback and individual support from the supervising physiotherapist, who will address any questions or difficulties encountered during the programme. Participants in both groups will be encouraged to maintain exercise logs and will receive periodic reminders to support consistent engagement throughout the study period.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eRelevant concomitant care permitted or prohibited during the trial {11d}\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eParticipants who are receiving other forms of structured physiotherapy or supervised exercise programmes for knee osteoarthritis will not be eligible to participate in the trial. Any initiation of new rehabilitation or exercise interventions during the trial will not be allowed.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003e\\u003cbr\\u003e\\u0026nbsp;Provisions for post-trial care {30}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eWe do not expect the intervention to pose any risk of harm to participants.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eOutcomes {12}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe primary outcome will be the change in knee function, measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score after 3 months of intervention compared with baseline.\\u003c/p\\u003e\\n\\u003cp\\u003eThe secondary outcomes will include:\\u003c/p\\u003e\\n\\u003col\\u003e\\n \\u003cli\\u003ePain intensity, assessed with the 11-point Numerical Rating Scale (NRS).\\u003c/li\\u003e\\n \\u003cli\\u003eKnee joint mobility, measured with a goniometer.\\u003c/li\\u003e\\n \\u003cli\\u003ePhysical activity levels assessed using the International Physical Activity Questionnaire (IPAQ).\\u003c/li\\u003e\\n \\u003cli\\u003eHealth-related quality of life, assessed with the 12-Item Short Form Health Survey (SF-12).\\u003c/li\\u003e\\n \\u003cli\\u003eExercise adherence and frequency, recorded via exercise diaries (control group) and digital communication logs (telerehabilitation group).\\u003c/li\\u003e\\n \\u003cli\\u003ePatient satisfaction with telerehabilitation, assessed with a 5-point Likert scale questionnaire.\\u003c/li\\u003e\\n \\u003cli\\u003eReasons for reduced adherence or discontinuation of exercise, assessed via structured self-report questionnaires.\\u003c/li\\u003e\\n\\u003c/ol\\u003e\\n\\u003cp\\u003eRandomisation will be performed in a 1:1 ratio using a computer-generated random sequence prepared by an independent statistician not otherwise involved in patient recruitment or outcome assessment. Allocation concealment will be ensured through sealed, opaque, sequentially numbered envelopes. The envelopes will be opened only after baseline assessment, at which point the physiotherapist will assign the patient to either the telerehabilitation or control group.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eQuestionnaires used to assess outcomes\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003eSociodemographic variables\\u003c/em\\u003e, namely sex, age (years), and anthropometric variables, body height (centimetres) and body weight (kilograms) for the calculation of BMI (calculated as weight in kilograms divided by height in metres squared), education, and current employment status.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003eAssessing mobility\\u003c/em\\u003e: A goniometer, a key component of the musculoskeletal examination, will be used to assess mobility. It documents the initial and subsequent range of motion [24].\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003ePain intensity assessment\\u003c/em\\u003e: To assess the intensity of the pain, we will use an 11-point Numerical Rating Scale (NRS), where 0 means no pain, and 10 represents the worst pain you can imagine. Pain assessment is an integral part of evaluating and monitoring your treatment. Pain intensity is probably the most crucial information about a patient\\u0026apos;s experience of pain [8], regardless of disability or disease. The NRS can be used to assess the intensity of current pain, usual (average) pain, worst pain or least severe pain over a given period, which should be clearly stated in the instructions and recorded alongside the score. The numbers should be written in ascending order from 0 to 10 from left to right, and both thresholds should be described [25]. Patients will be presented with the scale and will be told an integer number representing the rating of their pain intensity.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003ePhysical function, stiffness and pain\\u003c/em\\u003e: We will use the WOMAC pain scale to measure physical function, stiffness and pain. The scale is used to assess pain, stiffness and physical function in patients with OA of the knee joint. It was developed in 1982 by Nicolas Bellamy. It was initially designed to assess the treatment outcome in patients with rheumatoid arthritis but was later validated to evaluate hip and knee joint function. It is divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each item is rated on a Likert scale from 0 to 4 [8, 26] with a total score of 96. The lower the score, the better the functional status and the less pain. A score above 39 points indicates a worse functional status due to advanced wear changes. With the WOMAC scale, Soderman and Malchau confirmed a good association between pain and physical function [27]. The WOMAC is valid, reliable and responsive in several OA studies [28].\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003ePhysical activity assessment\\u003c/em\\u003e The International Physical Activity Questionnaire (IPAQ) will be used to assess physical activity. The IPAQ was developed by the World Health Organisation in 1998 to monitor physical activity and facilitate global comparisons [29]. It consists of 7 items and is widely used to measure physical activity levels [30]. Open-ended questions refer to the number of days and time spent in moderate-intensity, vigorous-intensity and walking physical activity lasting at least 10 minutes in the last 7 days. It also includes time spent sitting in the previous 7 days [31]. It allows the calculation of the metabolic equivalent (MET) by measuring the frequency, duration and intensity level of physical activity in the last 7 days. It represents the amount of physical activity per week. It is calculated as weekly work hours (MET-hours/week) [32].\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003e12-Item Short Form Health Survey\\u003c/em\\u003e Health-related quality of life assessment is essential to managing patients with chronic diseases [33]; we will use the SF-12 (Short Form 12), a general health questionnaire. It is a multipurpose general health measurement in short form, developed in 1995 by Ware, Kosinski and Keller (1995, p. 11) [34]. It allows for health status statements on eight dimensions [35] of patients with chronic conditions [36]. The SF-12 is a reliable measure and one of the most used instruments for assessing self-reported health-related quality of life [37]. Webster and Feller [38] confirmed in their study that the questionnaire is comparable to the more extended version of the SF-36 for measuring health-related quality of life over time in patients with knee OA.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003eAssessing improvements in knee joint function, mobility, and health-related quality of life\\u003c/em\\u003e: We will use existing scales to evaluate improvements in knee joint function, mobility and health-related quality of life, which we have adapted to our needs because we want to determine the impact of the outcomes of the telerehabilitation programme on the satisfaction of patients with OA of the knee joint. Patients will respond according to a 5-point Likert scale assessing mobility [39, 40], pain [41], stiffness, physical activity [25] and health-related quality of life [37].\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003eSatisfaction rating\\u003c/em\\u003e Patients will answer a 5-point Likert scale to assess their satisfaction with telerehabilitation using a web-based exercise app to increase knee joint mobility and strengthen muscles. They will rate the quality of the service, answering whether they received the service they wanted, whether the service fully met their needs, whether they would recommend the service to a friend, whether the service helped them improve knee joint function, mobility and health-related quality of life, whether they have seen much improvement since starting the exercise, whether they are satisfied with the service, and if they need similar services in the future, whether they would use the service again [13, 32, 42].\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003eMeasuring the reasons for reducing the frequency of exercise or discontinuing telerehabilitation\\u003c/em\\u003e To measure the reasons for reducing the frequency of exercise or discontinuing telerehabilitation, patients with knee OA undergoing telerehabilitation will respond to a 5-point Likert scale on whether they had technical problems, communication problems, problems with the content of the telerehabilitation itself, or whether they may have reduced or even discontinued telerehabilitation due to personal circumstances [43].\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cem\\u003eAssessing the benefits of using telerehabilitation\\u003c/em\\u003e Patients with OA of the knee joint undergoing telerehabilitation will rate the benefits of using telerehabilitation. They will respond on a 5-point Likert scale to 11 items on timesaving, money-saving, increased autonomy motivation, comfort, easier access to a physiotherapist(s), easier communication with a physiotherapist(s), and accuracy/veracity of information when using telerehabilitation. They will also assess the effectiveness of the exercise, give an opinion on the possibility of seeing the exercises multiple times and assess the ease of use of telerehabilitation [44].\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eSample size {14}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe sample size was calculated based on the study results Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial [41] using G*Power software version 3.1 [45]. To calculate the sample size, we used the results of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. The alpha error probability was set at 0.05, the 1-beta error probability was set at 0.80, and the effect size was taken from the study (0.288). A sample size of 74 subjects was calculated. Considering the expected % dropout rate of 15%, 85 subjects should be randomised, 43 in each group. To increase statistical power and ensure robustness, we will enrol 120 patients (60 per group).\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eRecruitment {15}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAll patients diagnosed with knee OA who present at Artros Medical Centre for an orthopaedic specialist consultation will undergo a radiological examination. Based on the radiographic findings and clinical evaluation, the orthopaedic specialist will refer eligible patients to a physiotherapist, who will assign them to the TR or UE group. The physiotherapist will provide both verbal and written explanations of the study procedures. Patients will be included in the study after providing written informed consent.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAssignment of interventions: allocation\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eSequence generation {16a}\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAfter participant and partner selection, we will allocate participants to intervention and control groups in a 1:1 ratio.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConcealment mechanism {16b}\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eRandomization will be performed by an external person not involved in the study.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eImplementation\\u003c/strong\\u003e\\u003cstrong\\u003e\\u0026nbsp;{16c}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe physiotherapist will collect baseline data, including: Sociodemographic characteristics, Anthropometric measurements: height (cm), weight (kg), body mass index (BMI) (kg/m\\u0026sup2;), Educational background and employment status, Knee joint mobility assessment using a goniometer, Pain intensity measurement using the Numerical Rating Scale (NRS), Physical function, stiffness, and pain assessment using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Physical activity evaluation using the International Physical Activity Questionnaire (IPAQ), Health-related quality of life assessment using the 12-Item Short Form Health Survey (SF-12), OA severity classification based on recent knee radiographs (\\u0026le; 4 months old), graded using the Kellgren-Lawrence classification system.\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAssignment of interventions: Blinding\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eWho will be blinded {17a}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eGiven the nature of the intervention, neither patients nor physiotherapists can be blinded to group allocation. However, the orthopaedic specialists performing clinical examinations and the research staff conducting outcome analyses will remain blinded. This blinding strategy reduces the risk of detection and assessment bias. Unblinding will be permitted only in the event of a serious adverse event that requires disclosure.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003e\\u003cbr\\u003e\\u0026nbsp;Procedure for unblinding if needed {17b}\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eNot relevant.\\u003cbr\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eData collection and management\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003ePlans for assessment and collection of outcomes {18a}\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eUpon enrolment, patients will receive detailed physiotherapeutic instructions. The rehabilitation protocol will be identical for both the TR and UE groups and will comprise:\\u003c/p\\u003e\\n\\u003cul\\u003e\\n \\u003cli\\u003eTargeted strengthening exercises for the core and lower limb musculature\\u003c/li\\u003e\\n \\u003cli\\u003eMobility exercises for the hip, knee, and ankle joints\\u003c/li\\u003e\\n \\u003cli\\u003eBalance and stabilisation exercises\\u003c/li\\u003e\\n\\u003c/ul\\u003e\\n\\u003cp\\u003eThe intervention is designed to be performed without external equipment, relying solely on body weight resistance exercises. Each session will last approximately 20\\u0026ndash;25 minutes, and patients will be instructed to complete the exercises three times per week, with a minimum interval of 24 hours and a maximum of 72 hours between sessions.\\u003c/p\\u003e\\n\\u003cp\\u003eTele-Rehabilitation Group\\u003c/p\\u003e\\n\\u003cp\\u003ePatients in the TR group will have access to continuous remote support from the physiotherapist, including:\\u003c/p\\u003e\\n\\u003cul\\u003e\\n \\u003cli\\u003eWeekly scheduled phone consultations\\u003c/li\\u003e\\n \\u003cli\\u003eLive virtual consultations via MS Teams, Zoom, or Skype\\u003c/li\\u003e\\n \\u003cli\\u003eText messages and emails for personalised guidance, motivation, and troubleshooting\\u003c/li\\u003e\\n\\u003c/ul\\u003e\\n\\u003cp\\u003eUnsupervised Exercise Group\\u003c/p\\u003e\\n\\u003cp\\u003ePatients in the UE group will receive only written exercise instructions and perform the rehabilitation programme independently at home without additional remote supervision.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eMidway Evaluation and Adherence Monitoring\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAs a motivational strategy, the physiotherapist will check in with patients in the UE group at the midpoint of the intervention period to assess adherence and potential barriers to exercise compliance. This midterm contact aims to identify and address patient-specific challenges and enhance adherence to the rehabilitation protocol.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003ePlans to promote participant retention and complete follow-up {18b}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAt three months post-intervention, the physiotherapist will conduct a follow-up evaluation, collecting additional data on Exercise adherence and frequency, Potential reasons for reduced exercise engagement or discontinuation of TR, and Patient-perceived benefits of the TR approach.\\u003c/p\\u003e\\n\\u003cp\\u003eAfter the intervention, all patients will undergo a final clinical assessment with the orthopaedic specialist. The physiotherapist will reassess joint mobility using a goniometer, and patients will complete standardised questionnaires evaluating Pain intensity (NRS), Knee function (WOMAC Index), Physical activity (IPAQ), Health-related quality of life (SF-12) and Overall satisfaction with the TR approach.\\u003c/p\\u003e\\n\\u003cp\\u003eAdditionally, patients will report reasons for potential reductions in exercise frequency or discontinuation and provide qualitative feedback on the TR approach\\u0026apos;s advantages and limitations.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eData management {19}\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe corresponding author, responsible for the data\\u0026apos;s confidentiality, will collect and store all data on paper. The project leader will print all questionnaires and have the patients complete them. The corresponding author will enter the data into anonymised tables, which will then be used for statistical processing. SPSS software will be used for statistical analysis.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConfidentiality {27}\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eBefore any statistical analysis, the data will be tested for normal distribution using the Kolmogorov-Smirnov (K-S) test. A t-test for independent samples will be used to determine the difference in patients with OA of the knee joint in terms of improvement in mobility, pain reduction and quality of life between the UE and the UE group who will exercise alone. A t-test for dependent samples will be used to determine the difference in knee joint function scores in patients with OA of the knee joint and the difference in physical activity of patients at the end of TS in UE compared to baseline. Multiple linear regression will be used to determine the impact of the outcomes of the UE programme (mobility, pain, stiffness, physical activity, health-related quality of life) on patients\\u0026apos; satisfaction with telerehabilitation.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eNot applicable.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eStatistical methods\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eStatistical methods for primary and secondary outcomes {20a}\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe statistical analysis will follow the intention-to-treat (ITT) principle, including all randomised participants in the groups to which they were assigned, regardless of adherence. Missing data will be addressed using multiple imputation techniques, and sensitivity analyses will be conducted to test the robustness of the findings. Imputation models will include baseline characteristics and all outcome variables.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eInterim analyses {21b}\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThere is no plan for any interim analysis or stopping data collection.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eMethods for additional analyses (e.g. subgroup analyses) {20b}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThere are no planned subgroup analyses for the primary or secondary outcomes.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eMethods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThis clinical trial aims to evaluate the effectiveness of the intervention under conditions that closely resemble real-world practice. It will therefore not be possible to fully eliminate the potential influence of confounding or modifying variables, such as concomitant treatments, participant withdrawal, or partial non-adherence to the intervention. For this reason, an intention-to-treat analysis has been chosen.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003ePlans to give access to the full protocol, participant level-data and statistical code {31c}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe complete study protocol, anonymised participant-level dataset, and statistical code will be available from the corresponding author upon reasonable request after publication of the main results. Data sharing will comply with the study\\u0026rsquo;s ethical approval and relevant data protection legislation.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eOversight and monitoring\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eComposition of the coordinating centre and trial steering committee {5d}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe study will be coordinated by the Faculty of Health, University of Novo Mesto, in collaboration with the Artros Medical Centre. The coordinating centre will supervise all study procedures, including recruitment, data management, and quality assurance. The trial steering committee, composed of the principal investigator, project supervisor, and collaborating researchers, will meet regularly\\u0026mdash;at least once per month\\u0026mdash;to review study progress, ensure adherence to the protocol, and resolve any procedural issues.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eComposition of the data monitoring committee, its role and reporting structure {21a}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eWe do not intend to establish a data oversight committee, as this is a low-risk intervention. We have submitted ethical reports to the Slovenian Medical Ethics Committee and ensured that all steps of the study follow the best standards of care.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAdverse event reporting and harms {22}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAll adverse or unintended effects will be promptly reported to the principal investigator, who will be responsible for their assessment, management, and, when appropriate, referral of participants to relevant clinical services.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eFrequency and plans for auditing trial conduct {23}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eMonthly meetings are expected to be held with at least the principal investigator and project supervisor present; whenever possible, trial audits will involve all investigators, either online or in person.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003ePlans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAny amendments to the study or protocol will be communicated to all investigators and the ethics committee.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eDissemination plans {31a}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eStudy results will be published in peer-reviewed journals and presented at scientific conferences.\\u003c/p\\u003e\"},{\"header\":\"Discussion\",\"content\":\"\\u003cp\\u003eThe present study protocol describes a randomised controlled trial evaluating the effectiveness of a structured telerehabilitation programme compared with unsupervised home-based exercise in patients with knee osteoarthritis. This trial addresses an important evidence gap by systematically assessing both clinical outcomes and patient-reported measures such as adherence, satisfaction, and quality of life.\\u003c/p\\u003e \\u003cp\\u003eStrengths of the study design include the randomised controlled design, use of validated outcome measures (WOMAC, NRS, IPAQ, SF-12), and standardized intervention protocols applied across both groups. The incorporation of patient-centered outcomes, such as satisfaction and reasons for discontinuation, will provide additional insights into the feasibility and acceptability of telerehabilitation. Furthermore, the relatively large sample size will increase statistical power and the generalizability of the findings.\\u003c/p\\u003e \\u003cp\\u003eLimitations should also be acknowledged. Due to the nature of the intervention, participants and physiotherapists cannot be blinded, which may introduce performance bias. Although outcome assessors will remain blinded, some risk of detection bias cannot be completely eliminated. Another limitation is the single-centre design, which may reduce external validity across different healthcare systems and cultural contexts. Moreover, the study duration of three months may not capture the long-term sustainability of telerehabilitation effects.\\u003c/p\\u003e \\u003cp\\u003ePotential challenges during implementation include variability in patient adherence to exercise protocols, technological barriers such as limited digital literacy or unstable internet connections, and motivational issues among patients exercising without direct supervision. These challenges will be mitigated through regular remote support in the telerehabilitation group and midterm adherence checks in the control group; however, some degree of non-adherence is expected.\\u003c/p\\u003e \\u003cp\\u003eImplications for clinical practice and health policy are substantial. If telerehabilitation proves to be effective, feasible, and acceptable, it may serve as a cost-effective and scalable complement to traditional rehabilitation, particularly in regions with limited access to physiotherapy services. The findings could inform the integration of digital health strategies into routine osteoarthritis management, improve patient-centered care, and potentially reduce healthcare costs related to disability and joint replacement surgery. Moreover, results may guide policymakers in developing reimbursement models and infrastructure investments to support the broader use of telerehabilitation. In addition, the evidence generated may contribute to future European and international guidelines for the management and rehabilitation of knee osteoarthritis.\\u003c/p\\u003e \\u003cp\\u003eFuture directions\\u003c/p\\u003e \\u003cp\\u003eThe primary aim of this study is to evaluate the effectiveness of a three-month telerehabilitation exercise programme in improving knee joint mobility, reducing pain, and enhancing overall function in patients with knee OA, compared to those performing exercises independently. The study will focus on assessing changes in pain, stiffness, and physical function of the knee joint, as well as the impact of telerehabilitation on patients' physical activity levels and overall quality of life. Additionally, patient satisfaction with telerehabilitation will be analysed, including improved knee function, mobility, and health-related quality of life.\\u003c/p\\u003e \\u003cp\\u003eFuture research should explore the long-term effects of telerehabilitation on knee OA management, assessing whether the benefits observed in mobility, pain reduction, and quality of life are sustained beyond the intervention period. Further studies could also investigate the cost-effectiveness of telerehabilitation compared to traditional rehabilitation and its potential for integration into routine clinical practice. Expanding the study to include a more extensive and more diverse patient population and evaluating different telerehabilitation modalities could provide deeper insights into optimising remote rehabilitation strategies for OA and other musculoskeletal conditions.\\u003c/p\\u003e \\u003cp\\u003e \\u003cb\\u003eTrial status\\u003c/b\\u003e \\u003c/p\\u003e \\u003cp\\u003ePatient recruitment for our study started in September 2025 at the Artros Orthopaedic Centre. The estimated time of recruitment completion is November 2025.\\u003c/p\\u003e\"},{\"header\":\"Abbreviations\",\"content\":\"\\u003cp\\u003eOA: osteoarthritis; unsupervised exercise (UE); UE control group; SF-36: 36-Item Short Form Health Survey; SF12: 12-Item Short Form Survey, IPAQ: International Physical Activity Questionnaire, WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index, MET: metabolic equivalent; NRS: 11-point Numerical Rating Scale; BMI: Body mass index; TEP: total endoprosthesis; PEP: partial endoprosthesis\\u003c/p\\u003e\"},{\"header\":\"Declarations\",\"content\":\"\\u003cp\\u003e\\u003cstrong\\u003eAcknowledgements\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe authors sincerely thank the physiotherapists for conducting all physical tests and for their support in implementing the study.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAuthors’ contributions {31b}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAll three authors contributed to the formation of the study protocol. PK and KE prepared the training protocol for the intervention group and provided outcome measures. PK and MH adjusted the new training protocol for clinical use. All together, we planned the timeline and safety protocols. PK collected all the data from previous studies and transferred new ideas to the comprehensive study protocol. KE and MH developed the protocol. The authors read and approved the final manuscript.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eFunding {4}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe Slovenian Research and Innovation Agency and Artros d.o.o. [grant number L7-50184] supported this work.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAvailability of data and materials {29}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe data supporting this study's findings are available on request from the corresponding author.\\u0026nbsp;\\u003cbr\\u003e\\u0026nbsp;\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eEthics approval and consent to participate {24}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eEthical approval for this study was obtained from the National Committee on Medical Ethics of the Republic of Slovenia (No. 0120–471/2023-2711-4). Informed consent to participate was obtained from all individual participants.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eConsent for publication {32}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eNot applicable. This manuscript does not contain any person’s data in any form (including individual details, images, or videos) that would require consent for publication.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eCompeting interests {28}\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe authors declare no competing interests.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003eAuthors’\\u0026nbsp;\\u003c/strong\\u003e\\u003cstrong\\u003einformation (optional)\\u0026nbsp;\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003e1,2 Faculty of Health, University of Novo Mesto, Novo Mesto, Slovenia\\u003c/p\\u003e\\n\\u003cp\\u003e3 Artros d.o.o, Tehnološki park 19, Ljubljana, 1000, Slovenia\\u003c/p\\u003e\"},{\"header\":\"References\",\"content\":\"\\u003col\\u003e\\n\\u003cli\\u003eDhillon MS, Patel S, John R. PRP in OA knee - update, current confusions and future options. SICOT J. 2017;3:27. doi:10.1051/sicotj/2017004\\u003c/li\\u003e\\n\\u003cli\\u003eMoutzouri M, Koumantakis GA, Hurley M, Kladouchou AG, Gioftsos G. Effectiveness of a web-guided self-managed telerehabilitation enhanced with outdoor physical activity on physical function, physical activity levels and pain in patients with knee osteoarthritis: a controlled trial. J Clin Med. 2024;13(4):934. doi:10.3390/jcm13040934\\u003c/li\\u003e\\n\\u003cli\\u003ePinto Barbosa S, Marques L, Sugawara A, Toledo F, Imamura M, Battistella L, Simis M, Fregni F. Predictors of the health-related quality of life (HRQOL) in SF-36 in knee osteoarthritis patients: a multimodal model with moderators and mediators. Cureus. 2022;14(7):e27339. doi:10.7759/cureus.27339\\u003c/li\\u003e\\n\\u003cli\\u003eWallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017;114(35):9332-9336. doi:10.1073/pnas.1703856114\\u003c/li\\u003e\\n\\u003cli\\u003eHafer JF, Kent JA, Boyer KA. Physical activity and age-related biomechanical risk factors for knee osteoarthritis. Gait Posture. 2019;70:24-29. doi:10.1016/j.gaitpost.2019.02.008\\u003c/li\\u003e\\n\\u003cli\\u003eLeifer VP, Katz JN, Losina E. The burden of OA-health services and economics. Osteoarthritis Cartilage. 2022;30:10-16. https://www.sciencedirect.com/science/article/pii/S106345842100738X\\u003c/li\\u003e\\n\\u003cli\\u003eEyles JP, Hunter DJ, Bennell KL, Dziedzic K, Hinman RS, van der Esch M, Holden MA, Bowden JL, Joint Effort Initiative Members. Priorities for the effective implementation of osteoarthritis management s: an OARSI international consensus exercise. Osteoarthritis Cartilage. 2019;27:1270-1279. doi:10.1016/j.joca.2019.05.015\\u003c/li\\u003e\\n\\u003cli\\u003eXie SH, Wang Q, Wang LQ, Wang L, Song KP, He CQ. Effect of internet-based rehabilitation s on improvement of pain and physical function in patients with knee osteoarthritis: systematic review and meta-analysis of controlled trials. J Med Internet Res. 2021;23(1):e21542. doi:10.2196/21542\\u003c/li\\u003e\\n\\u003cli\\u003eDantas LO, Salvini TDF, McAlindon TE. Knee osteoarthritis: key treatments and implications for physical therapy. Braz J Phys Ther. 2020;25(2):135-146. doi:10.1016/j.bjpt.2020.08.004\\u003c/li\\u003e\\n\\u003cli\\u003eLong H, Liu Q, Yin H, Wang K, Diao N, Zhang Y, Lin J, Guo A. Prevalence trends of site-specific osteoarthritis from 1990 to 2019: findings from the Global Burden of Disease Study 2019. Arthritis Rheumatol. 2022;74(7):1172-1183. doi:10.1002/art.42089\\u003c/li\\u003e\\n\\u003cli\\u003eSalmon JH, Rat AC, Sellam J, Michel M, Eschard JP, Guillemin F, Jolly D, Fautrel B. Economic impact of lower-limb osteoarthritis worldwide: a systematic review of cost-of-illness studies. Osteoarthritis Cartilage. 2016;24:1500-1508. doi:10.1016/j.joca.2016.03.012\\u003c/li\\u003e\\n\\u003cli\\u003eAmerican Academy of Orthopaedic Surgeons (AAOS). Management of osteoarthritis of the knee (non-arthroplasty). Rosemont: AAOS; 2021. https://www.aaos.org/oak3cpg\\u003c/li\\u003e\\n\\u003cli\\u003eMoutzouri M, Gioftsos G. How effective is a blended web-based rehabilitation for improving pain, physical activity, and knee function of patients with knee osteoarthritis? Study protocol for a control trial. PLoS ONE. 2022;17(5):e0268652. doi:10.1371/journal.pone.0268652\\u003c/li\\u003e\\n\\u003cli\\u003eCieślik B, Kuligowski T, Cacciante L, Kiper P. The impact of personality traits on patient satisfaction after telerehabilitation: a comparative study of remote and face-to-face musculoskeletal rehabilitation during COVID-19 lockdown. Int J Environ Res Public Health. 2023;20(6):5019. doi:10.3390/ijerph20065019\\u003c/li\\u003e\\n\\u003cli\\u003eFiani B, Siddiqi I, Lee SC, Dhillon L. Telerehabilitation: development, application, and need for increased usage in the COVID-19 era for patients with spinal pathology. Cureus. 2020;12(9):e10563. doi:10.7759/cureus.10563\\u003c/li\\u003e\\n\\u003cli\\u003eLatif-Zade T, Tucci B, Verbovetskaya D, Bialkin E, Ng B, Heddon S, Berteau JP. Systematic review shows tele-rehabilitation might achieve comparable results to office-based rehabilitation for decreasing pain in patients with knee osteoarthritis. Medicina (Kaunas). 2021;57(8):764-771. doi:10.3390/medicina57080764\\u003c/li\\u003e\\n\\u003cli\\u003eSteultjens MP, Dekker J, van Baar ME, Oostendorp RA, Bijlsma JW. Range of joint motion and disability in patients with osteoarthritis of the knee or hip. Rheumatology (Oxford). 2000;39(9):955\\u0026ndash;961. doi:10.1093/rheumatology/39.9.955\\u003c/li\\u003e\\n\\u003cli\\u003eCronstr\\u0026ouml;m A, Dahlberg LE, Nero H, Ericson J, Hammarlund CS. \\u0026apos;I would never have done it if it hadn\\u0026apos;t been digital\\u0026apos;: a qualitative study on patients\\u0026apos; experiences of a digital management me for hip and knee osteoarthritis in Sweden. BMJ Open. 2019;9(5):e028388. doi:10.1136/bmjopen-2018-028388\\u003c/li\\u003e\\n\\u003cli\\u003eOA Action. OA prevalence and burden [Internet]. 2022 Sep 9 [cited 2025 Aug 23]. Available from: https://oaaction.unc.edu/wp-content/uploads/sites/623/2019/08/FINAL-OA-Prevalence-and-Burden-final.pdf\\u003c/li\\u003e\\n\\u003cli\\u003eAzma K, Soltani ZR, Rezaeimoghaddam F, Dadarkhah A, Mohsenolhosseini S. Efficacy of tele-rehabilitation compared with office-based physical therapy in patients with knee osteoarthritis: a clinical trial. J Telemed Telecare. 2018;24(8):560-565. doi:10.1177/1357633X17723368\\u003c/li\\u003e\\n\\u003cli\\u003eGustafson JA, Gorman S, Fitzgerald GK, Farrokhi S. Alterations in walking knee joint stiffness in individuals with knee osteoarthritis and self-reported knee instability. Gait Posture. 2016;43:210\\u0026ndash;215. doi:10.1016/j.gaitpost.2015.09.025\\u003c/li\\u003e\\n\\u003cli\\u003eSalmon JH, Rat AC, Achit H, Ngueyon-Sime W, Gard C, Guillemin F, Jolly D, Fautrel B. Health resource use and costs of symptomatic knee and/or hip osteoarthritis. Osteoarthritis Cartilage. 2019;27:1011-1017. doi:10.1016/j.joca.2019.03.005\\u003c/li\\u003e\\n\\u003cli\\u003eWu Z, Zhou R, Zhu Y, Zeng Z, Ye Z, Wang Z, Liu W, Xu X. Self-management for knee osteoarthritis: a systematic review and meta-analysis of controlled trials. Pain Res Manag. 2022;2022:2681240. doi:10.1155/2022/2681240\\u003c/li\\u003e\\n\\u003cli\\u003eLatreche A, Kelaiaia R, Chemori A, Kerboua A. Reliability and validity analysis of MediaPipe-based measurement system for some human rehabilitation motions. Measurement. 2023;214:112826. doi:10.1016/j.measurement.2023.112826 \\u003c/li\\u003e\\n\\u003cli\\u003eHrvatin I, Puh U. Measurement properties of the numerical pain rating scale in patients with musculoskeletal impairments of the limbs \\u0026ndash; a systematic literature review. Zdrav Vestn. 2021;90(9\\u0026ndash;10):512\\u0026ndash;520. doi:10.6016/ZdravVestn.3108\\u003c/li\\u003e\\n\\u003cli\\u003eClement ND, Bardgett M, Weir D, Holland J, Gerrand C, Deehan DJ. What is the minimum clinically important difference for the WOMAC index after TKA? Clin Orthop Relat Res. 2018;476(10):2005\\u0026ndash;2014. doi:10.1097/CORR.0000000000000444 \\u003c/li\\u003e\\n\\u003cli\\u003ePlaskan L, Vogrin Hudopisk K, Bavec A. Ocenjevanje izida po vstavitvi totalne endoproteze kolka. Rehabilitacija. 2016;15(1):71\\u0026ndash;76\\u003c/li\\u003e\\n\\u003cli\\u003eHall M, Hinman RS, Wrigley TV, Kasza J, Lim BW, Bennell KL. Knee extensor strength gains mediate symptom improvement in knee osteoarthritis: secondary analysis of a randomised controlled trial. Osteoarthritis Cartilage. 2018;26:495\\u0026ndash;500. doi:10.1016/j.joca.2018.01.018\\u003c/li\\u003e\\n\\u003cli\\u003eLee PH, Yu Y, McDowell I, Leung GM, Lam TH, Stewart SM. Performance of the International Physical Activity Questionnaire (short form) in subgroups of the Hong Kong Chinese population. Int J Behav Nutr Phys Act. 2011;8:81. doi:10.1186/1479-5868-8-81\\u003c/li\\u003e\\n\\u003cli\\u003eOliveira JM, Spositon T, Rugila DF, Pitta F, Furlanetto KC. Validity of the International Physical Activity Questionnaire (short form) in adults with asthma. PLoS One. 2023;18(2):e0282137. doi:10.1371/journal.pone.0282137\\u003c/li\\u003e\\n\\u003cli\\u003eJoseph KL, Dagfinrud H, Christie A, Hagen KB, Tveter AT. Criterion validity of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) for use in clinical practice in patients with osteoarthritis. BMC Musculoskelet Disord. 2021;22:232. doi:10.1186/s12891-021-04069-z\\u003c/li\\u003e\\n\\u003cli\\u003eTore NG, Oskay D, Haznedaroglu S. The quality of physiotherapy and rehabilitation and the effect of telerehabilitation on patients with knee osteoarthritis. Clin Rheumatol. 2023;42(3):903\\u0026ndash;915. doi:10.1007/s10067-022-06417-3\\u003c/li\\u003e\\n\\u003cli\\u003eLajlar N, Moharič M, Vidmar G. Psihometrične lastnosti slovenskega prevoda vpra\\u0026scaron;alnika o kakovosti življenja pri bolnikih z genetsko obliko živčno-mi\\u0026scaron;ičnih bolezni. Rehabilitacija. 2021;20(2):4\\u0026ndash;12.\\u003c/li\\u003e\\n\\u003cli\\u003eShah CH, Brown JD. Reliability and validity of the short-form 12 item version 2 (SF-12v2) health-related quality of life survey and disutilities associated with relevant conditions in the U.S. older adult population. J Clin Med. 2020;9(3):661. doi:10.3390/jcm9030661\\u003c/li\\u003e\\n\\u003cli\\u003eAwell Health. 12-Item Short Form Survey (SF12) Clinical Workflow [Internet]. [cited 2025 Aug 23]. Available from: https://www.awellhealth.com/care-flow-library/12-item-short-form-survey-sf12-flow \\u003c/li\\u003e\\n\\u003cli\\u003eRAND Corporation. 12-Item Short Form Survey (SF-12) [Internet]. [cited 2025 Aug 23]. Available from: https://www.rand.org/health-care/surveys_tools/mos/12-item-short-form.html \\u003c/li\\u003e\\n\\u003cli\\u003eHuo T, Guo Y, Shenkman E, Muller K. Assessing the reliability of the short form 12 (SF-12) health survey in adults with mental health conditions: a report from the wellness incentive and navigation (WIN) study. Health Qual Life Outcomes. 2018;16:34. doi:10.1186/s12955-018-0858-2\\u003c/li\\u003e\\n\\u003cli\\u003eWebster KE, Feller JA. Comparison of the short form 12 (SF 12) health status questionnaire with the SF 36 in patients with knee osteoarthritis who have replacement surgery. Knee Surg Sports Traumatol Arthrosc. 2016;24:2620\\u0026ndash;2626. doi:10.1007/s00167-015-3904-1\\u003c/li\\u003e\\n\\u003cli\\u003eChan AW, Tetzlaff JM, G\\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hr\\u0026oacute;bjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi:10.1136/bmj.e7586\\u003c/li\\u003e\\n\\u003cli\\u003eSch\\u0026ouml;n C, Reule C, Knaub K, Micka A, Wilhelm M, Alt W, Menzel D. Evaluation and validation of a joint stress test to induce activity-related knee joint discomfort - a prospective case-control study. Sports Med Open. 2021;7:24. doi:10.1186/s40798-021-00317-7 \\u003c/li\\u003e\\n\\u003cli\\u003eHinman RS, Campbell PK, Lawford BJ, Briggs AM, Gale J, Bills C, Kasza J, Harris A, French SD, Bunker SJ, Forbes A, Bennell KL. Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial. Br J Sports Med. 2020;54(13):790\\u0026ndash;797. doi:10.1136/bjsports-2019-101183\\u003c/li\\u003e\\n\\u003cli\\u003ePedersen H, Skliarova T, Attkisson CC, Lara-Cabrera ML, Havnen A. Measuring patient satisfaction with four items: validity of the client satisfaction questionnaire 4 in an outpatient population. BMC Psychiatry. 2023;23:808. doi:10.1186/s12888-023-05310-w\\u003c/li\\u003e\\n\\u003cli\\u003eOu\\u0026eacute;draogo F, Auger LP, Moreau E, C\\u0026ocirc;t\\u0026eacute; O, Guerrera R, Rochette A, Kairy D. Acceptability of telerehabilitation: experiences and perceptions by individuals with stroke and caregivers in an early supported discharge. Healthcare (Basel). 2024;12(3):365. doi:10.3390/healthcare12030365\\u003c/li\\u003e\\n\\u003cli\\u003eChivate S, Sharma M, Shaikh A, Satarkar C. Benefits and challenges of telerehabilitation use by pediatric physiotherapists during the COVID-19 pandemic in Western and Southern India: a cross-sectional survey. Int J Telerehabil. 2022;14(1):e6466. doi:10.5195/ijt.2022.6466 \\u003c/li\\u003e\\n\\u003cli\\u003eFaul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009;41(4):1149\\u0026ndash;1160. doi:10.3758/BRM.41.4.1149\\u003c/li\\u003e\\n\\u003c/ol\\u003e\"}],\"fulltextSource\":\"\",\"fullText\":\"\",\"funders\":[],\"hasAdminPriorityOnWorkflow\":false,\"hasManuscriptDocX\":true,\"hasOptedInToPreprint\":true,\"hasPassedJournalQc\":\"\",\"hasAnyPriority\":false,\"hideJournal\":false,\"highlight\":\"\",\"institution\":\"\",\"isAcceptedByJournal\":false,\"isAuthorSuppliedPdf\":false,\"isDeskRejected\":\"\",\"isHiddenFromSearch\":false,\"isInQc\":false,\"isInWorkflow\":false,\"isPdf\":false,\"isPdfUpToDate\":true,\"isWithdrawnOrRetracted\":false,\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"trials\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":false,\"externalIdentity\":\"trls\",\"sideBox\":\"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)\",\"snPcode\":\"13063\",\"submissionUrl\":\"https://www.editorialmanager.com/trls\",\"title\":\"Trials\",\"twitterHandle\":\"MedicalEvidence\",\"acdcEnabled\":true,\"dfaEnabled\":true,\"editorialSystem\":\"em\",\"reportingPortfolio\":\"BMC/SO AJ\",\"inReviewEnabled\":true,\"inReviewRevisionsEnabled\":true},\"keywords\":\"Knee osteoarthritis, Telerehabilitation, Exercise therapy, Digital health, Home-based exercise, Randomised controlled trial, Rehabilitation adherence, Physical function, Health-related quality of life, Patient satisfaction\",\"lastPublishedDoi\":\"10.21203/rs.3.rs-8001912/v1\",\"lastPublishedDoiUrl\":\"https://doi.org/10.21203/rs.3.rs-8001912/v1\",\"license\":{\"name\":\"CC BY 4.0\",\"url\":\"https://creativecommons.org/licenses/by/4.0/\"},\"manuscriptAbstract\":\"\\u003cp\\u003e\\u003cb\\u003eBackground\\u003c/b\\u003e\\u003c/p\\u003e \\u003cp\\u003eKnee osteoarthritis (OA) is one of the leading causes of disability worldwide, with increasing prevalence and high societal and economic burden. Exercise-based rehabilitation is recommended as first-line management, yet adherence to unsupervised home exercise is often low. Telerehabilitation has the potential to improve access, adherence, and clinical outcomes; however, high-quality randomised controlled trials (RCTs) directly comparing structured telerehabilitation with unsupervised exercise remain scarce.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eMethods\\u003c/b\\u003e\\u003c/p\\u003e \\u003cp\\u003eThis study is a single-centre, parallel-group randomised controlled trial designed to evaluate the effectiveness of a 3-month telerehabilitation programme compared with unsupervised home-based exercise in patients with knee OA. A total of 120 patients with radiographically confirmed knee OA (Kellgren-Lawrence grade 1\\u0026ndash;3) will be randomised in a 1:1 ratio to either the telerehabilitation (TR) group or the control (unsupervised exercise, UE) group. Both groups will follow the same standardized exercise protocol, consisting of strengthening, mobility, and balance exercises performed three times per week. The TR group will additionally receive weekly remote supervision via phone or video consultations, supplemented with electronic reminders and motivational support.\\u003c/p\\u003e\\u003cp\\u003e\\u003cb\\u003eTrial registration\\u003c/b\\u003e\\u003c/p\\u003e \\u003cp\\u003eClinicalTrials.gov NCT07137897. Registered on 26 August 2025. 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