Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR) (MOKneeTOR)

Cost and Outcomes of Hospital-based Physiotherapy Versus mHealth-based Self-directed Rehabilitation in Patients With Knee Osteoarthritis: A Randomized, Controlled, Non-inferiority Trial

Symptomatic osteoarthritis (OA) of the knee affects approximately one-fifth (~300K) of Singaporeans aged 50 years or older, with the disease prevalence increasing with age. Patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. With an ageing population and the high prevalence of obesity, the annual number of TKRs is projected to rise. Thus, innovative care models are urgently needed to improve patient outcomes while managing or reducing the economic burden of this common and costly public health problem.

Unmet Need: Conservative treatment through physiotherapy rehabilitation is a key intervention, but significant access limitations result in unnecessary TKRs. For patients with knee OA, consensus guidelines are unanimous in recommending education, exercise, and weight management (if required) as first-line interventions. Physiotherapy rehabilitation incorporates these three first-line interventions and is a widely advocated and evidence-based component of OA management. Despite this, international evidence suggests that these core interventions are often under-utilized, with only 20-40% of community-dwelling older adults with knee OA receiving them. Locally and worldwide, suboptimal care from rehabilitation non-attendance is prevalent and costly: available research suggests that at least a quarter of TKRs could have been avoided with optimal care. Thus, to reduce the economic burden of OA, there is a need to develop innovative and flexible rehabilitation strategies.

A mobile health (mHealth)-based program is a likely solution to address this unmet need, but local contextualization is needed. Against this background, an mHealth-based OA self-management program may be a feasible solution to deliver guideline-based interventions, with minimal involvement by healthcare professionals. Whilst several app- or web-based OA self-management programs are available, few have undergone rigorous randomized controlled trial (RCT) evaluation, and still fewer provide detailed instructions to enable self-directed exercise (in particular, muscle strengthening exercises) - despite the evidence that exercise is the cornerstone of knee OA management. Furthermore, the reach and adoption of these programs in Singapore is limited as they are designed for English-speaking patients from Western cultures. Hence, whilst there are potential benefits in harnessing technology-enabled programs, these data emphasize the need for local co-design and adaptation to suit the Singapore context and to facilitate adoption.

Thus, the investigators have, through an iterative user-centered design process, developed Managing Osteoarthritis of the Knee using Therapist Technology Optimized Rehabilitation (MOKneeTOR), a blended digital rehabilitation program integrating an initial face-to-face physiotherapy assessment and an mHealth-enabled exercise and self-management program designed to promote first-line interventions (education, exercise, and weight management where indicated) for patients with knee osteoarthritis.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthristis
• Intervention / Treatment: Other: Hospital-based outpatient rehabilitation program; Device: MOKneeTOR with standard app configuration; Device: MOKneeTOR with standard app configuration and enhanced personalisation

Detailed Description

Study Hypotheses

Primary hypothesis: The MOKneeTOR program will be non-inferior to hospital-based physiotherapy rehabilitation at 3 and at 6 months in improving physical function (fast gait speed).

Secondary hypothesis: The MOKneeTOR program will be more cost-effective than hospital-based physiotherapy rehabilitation in reducing total OA-related costs.

Approach and Methods

This will be an assessor-blinded, parallel design, non-inferiority randomized controlled trial, with assessments done at baseline, 3 months, and 6 months after randomization. The protocol conforms to the CONSORT guidelines for eHealth interventions and non-inferiority RCTs.

Participants

Study participants will be recruited from a large pool of patients who are referred by orthopaedic surgeons for conservative physiotherapy management in Singapore General Hospital (SGH). Informed, written consent by each participant will be obtained. Study treatments, but not the study hypotheses, will be disclosed to participants; therefore, participants will be unaware of the hypothesized direction of effect.

Randomization To maintain allocation concealment, randomization will be undertaken only after completion of baseline outcome assessment. Participants will be randomized using minimal sufficient balance (MSB) randomization, a covariate-adaptive randomization method designed to ensure covariate balance on the key variables of age, sex, treating physiotherapists, and baseline knee pain intensity. The first 20 patients will be allocated in a 1:1 ratio to MOKneeTOR program or outpatient physiotherapy rehabilitation program using simple randomization, after which the computer-generated MSB algorithm will be activated. To support an exploration of potential mechanisms through which our MOKneeTOR mobile app improves management adherence, participants randomized to the MOKneeTOR program will undergo a second randomization (1:1) to receive either (i) MOKneeTOR with the standard MOKneeTOR app configuration or (ii) MOKneeTOR with enhanced personalization of the MOKneeTOR app (e.g., personalized UI such as tailored caricature, preferred colour scheme and customizable chatbot settings that allow patients to choose between concise or detailed replies). Notably, this 2:1:1 design will optimize our ability to assess the overall effects of the MOKneeTOR program relative to outpatient physiotherapy rehabilitation program while also allow an exploration of potential mechanistic effects of the MOKneeTOR app.

Participants randomized to MOKneeTOR program may optionally nominate one adult support person (SP) (e.g., family member/friend) to receive access to an SP version of the MOKneeTOR mobile app. The SP app is a subset of the patient app and is intended to (i) improve SP's knee OA knowledge and (ii) support SP's efforts in supporting the participant's self-management. The SP app displays the participant's progress summaries (exercise and physical activity frequency) and delivers informational and encouragement messages to the SP. Participation of an SP is optional and does not affect the participant's clinical care or trial participation.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong Hao Pua, PhD; Phone Number: 90188129; Email: pua.yong.hao@sgh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Singapore General Hospital
    • Contact: Yong Hao Pua, PhD; Phone Number: 90188129; Email: pua.yong.hao@sgh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients who meet the knee OA clinical criteria (aged ≥45 years, activity-related knee pain, and ≤30 min knee joint stiffness in the morning) will be included,
• an owner of a smartphone,
• an education level of at least 8 years,
• a willingness to be randomized to either MOKneeTOR program or outpatient rehabilitation program,
• an ability to complete baseline assessment.

Exclusion Criteria:

• lower limb joint replacement surgery anticipated within the next 6 months,
• rheumatoid arthritis and other systemic arthritis,
• a previous history of stroke and other major neurological conditions,
• significant back or other non-knee pain,
• pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hospital-based outpatient rehabilitation program; Participants will attend, over a 12-week period, a minimum of 3 outpatient physiotherapy sessions, with up to 3 additional sessions if patients are deemed to require them.	Other: Hospital-based outpatient rehabilitation program; Participants will attend, over a 12-week period, a minimum of 3 outpatient physiotherapy sessions, with up to 3 additional sessions if patients are deemed to require them. During the sessions, participants will receive patient education, exercises, manual therapy, and other modalities. Participants will also be instructed on a home exercise program in which they will exercise at least 3 times weekly. During each session which will last around 40 minutes, the project physiotherapist will (i) review the home exercise program, (ii) observe the participants performing the exercises and correct their form and techniques when necessary, and (iii) work with the participants to set goals and progress the exercise program.
Experimental: MOKneeTOR with standard app configuration; MOKneeTOR with standard app configuration will combine both self-reported outcomes and performance-based outcomes to provide objective exercise feedback and criterion-based personalized exercise progression recommendations.	Device: MOKneeTOR with standard app configuration; Participants allocated to the MOKneeTOR program will receive 24 week access to the MOKneeTOR app. To onboard participants on the use of the MOKneeTOR app, the MOKneeTOR program is designed to include an in-person outpatient session, during which the physiotherapist will guide participants through the system. Importantly, based on assessment findings and data input by the physiotherapist, the MOKneeTOR app will utilize a care stratification approach by selecting educational materials tailored to the participant's needs. Participants randomized to MOKneeTOR program may optionally nominate one adult support person (SP) (e.g., family member/friend) to receive access to an SP version of the MOKneeTOR mobile app. The SP app is a subset of the patient app and is intended to (i) improve SP's knee OA knowledge and (ii) support SP's efforts in supporting the participant's self-management.
Experimental: MOKneeTOR with standard app configuration and enhanced personalisation; MOKneeTOR with enhanced personalization will receive MOKneeTOR with standard app configuration and an app experience with an education chatbot that adapts tone, reading level, and format (text, infographics, short videos) to participants' preferences and engagement. Minor person-centred features (e.g., treating therapist caricature avatars and name-badged messages) will also be incorporated to strengthen therapeutic alliance without altering clinical guidance.	Device: MOKneeTOR with standard app configuration and enhanced personalisation; Participants randomized to receive MOKneeTOR with enhanced personalization of the MOKneeTOR app will receive an app experience with an education chatbot that adapts tone, reading level, and format (text, infographics, short videos) to participants' preferences and engagement. Minor person-centred features (e.g., treating therapist caricature avatars and name-badged messages) will also be incorporated to strengthen therapeutic alliance without altering clinical guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	This provides a performance-based measure of physical function. Participants will walk at their usual pace (warm-up) and fast pace along a 4-metre walkway, with a 2.5-metre acceleration distance before and a 2.5-metre deceleration distance after the timed section. Gait timing will be captured concurrently using both a stopwatch and a time-of-flight sensor. Gait speed (m/s) will be calculated for both walking conditions; however, time-of-flight sensor-based fast-paced gait speed will be the primary outcome measure.	baseline, 3 months and 6 months post baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee strength	Maximum quadriceps strength will be assessed on a seated knee extension machine using a standardized one repetition maximum (1RM) protocol.	baseline, 3 months and 6 months post baseline
Lower limb strength and mobility	This will be measured by the 5-times sit-to-stand test. Participants will perform the tests at their usual (warm-up) and fast pace, and their timing will be concurrently captured using both a stopwatch and a smartphone.	baseline, 3 months and 6 months post baseline
Treatment satisfaction	Participants will rate their satisfaction with rehabilitation on a 11-point numeric rating scale, with 0 indicating "not at all satisfied " and 10 indicating "totally satisfied".	3 months post baseline
Treatment recommendation	Participants will rate how likely they are to recommend this treatment to a friend or family member with knee arthritis using an 11-point numeric rating scale (allowing for 0.5 increments). A score of 0 indicates "Not at all likely," and a score of 10 indicates "Extremely likely."	3 months post baseline
Global perceived effect (GROC)	GROC of overall change in pain and change in physical function since baseline will be measured using a 9-point ordinal scale, with 1 indicating "Much better" and 9 indicating "Much worse".	3 months post baseline
Exercise Compliance	Participants will respond to the question "I do my knee strengthening exercises as often as recommended/advised," using a 0-10 scale (0 = strongly disagree, 10 = strongly agree).	3 months post baseline
Exercise Compliance	Participants will report their knee strenghtening exercise frequency (days per week).	3 months and 6 months post baseline
App usability	The usability of the MOKneeTOR app will be measured using the System Usability Scale (SUS), which is a validated 10 item questionnaire that assesses perceived usability. Qualitative feedback from participants will be collected to help identify intervention elements that are perceived to be useful. Additionally, user engagement and usage metrics will be automatically captured by the system backend throughout the study.	3 months post baseline
Short Form of the Western Ontario and McMaster Universities Osteoarthritis Index (ShortMAC F)	The Short Form of the Western Ontario and McMaster Universities Osteoarthritis Index (ShortMAC-F) is an OA-specific questionnaire designed to measure physical function. Total scores range from 0 to 100, with higher scores representing greater function.	baseline, 3 months and 6 months post baseline
Knee Pain: Numeric Pain Rating Scale (NPRS)	Knee pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), inquiring about the average pain intensity level over the past 1 week. Scores range from 0 to 10, where higher scores indicate greater pain intensity.	baseline, 3 months and 6 months post baseline
Health-related quality of life - Euro Qol Group 5-Dimension (EQ-5D-5L)	The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a health-related quality of life instrument with established psychometric properties in Singaporeans. Quality-adjusted-life-years (QALY), derived from the EQ-5D-5L utility index scores (which range from less than 0 to 1.0, where higher scores indicate a better health-related quality of life), will be the primary economic outcome used in the cost-utility analysis.	baseline, 3 months and 6 months post baseline
Cost outcomes: Healthcare utilization costs	Between the baseline and the Month-6 assessment, the investigators will use the modified OA Cost and Consequences Questionnaire (OCC-Q) to measure the use of other health and home care services, including hospitalizations, co interventions, visits to healthcare providers (e.g., doctors and other healthcare professionals), and prescribed or over-the counter medications. The investigators will also collect information on participants' employment and income status and assess productivity losses, including restricted activity days (such as sick leave taken by participants and leave of absence taken by their caregivers).	3 months and 6 months post baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded.	3 months and 6 months post baseline
Body weight and overall muscle mass/strength measurements [Mechanistic Outcome]	This will be measured using a calibrated scale for body weight and bioelectrical impedance analysis (BIA) to assess body composition (e.g., fat mass, lean mass). As a proxy measure of overall muscle strength, handgrip strength of the dominant hand was measured using a Jamar Plus digital dynamometer. In the sitting position with the elbow flexed at 90degrees, each participant will perform three maximal trials with 30 s rest between trials, and the highest reading will be analyzed. These measures will help explore whether changes in body composition mediate improvements in physical function and pain.	baseline, 3 months and 6 months post baseline
Perceived TKR Necessity [Mechanistic Outcome]	Participants will respond to the question "Based on your knee symptoms in the past week, how willing would you be to have knee surgery if you were medically fit to do so?" using a 0-10 scale (0 = not at all willing, 10 = definitely willing). They will also respond to the question "How necessary do you think knee replacement surgery is for your condition?" using a 0-10 scale (0 = not at all necessary, 10 = totally necessary).	baseline, 3 months and 6 months post baseline
Planned Walking Activities (IPEQ-W) [Mechanistic Outcome]	Participants will report their planned walking activities using the walking subscale of the Incidental and Planned Exercise Questionnaire (IPEQ-W). They will indicate the frequency and duration of planned walking sessions over the past week. This measure captures structured walking exercise intended for health or fitness purposes, rather than incidental walking (e.g., walking for transport).	baseline, 3 months and 6 months post baseline
Knee range-of-motion	A long-arm goniometer will be used to measure active-assisted knee flexion and extension range-of-motion with the participants in supine position.	baseline, 3 months and 6 months post baseline
Weight bearing symmetry [Mechanistic Outcome]	This assesses the ability of the participants to weight bear on both limbs. With their feet on 2 portable force plate, participants will stand up from a standard chair, and weightbearing symmetry is calculated by expressing the peak force produced by the involved leg as a percentage of that produced by the uninvolved leg.	baseline, 3 months and 6 months post baseline
Pain self-efficacy [Mechanistic Outcome]	This will be measured by the pain subscale of the Arthritis Self-Efficacy Scale (ASES), which measures a person's confidence in managing arthritis pain symptoms. Scores range from 1 to 10, where higher scores indicate greater self-efficacy.	baseline, 3 months and 6 months post baseline
OA knowledge [Mechanistic Outcome]	This will be measured using the Knee Osteoarthritis Knowledge Scale (KOAKS). Total score ranges from 11 to 55, and higher scores indicate greater knowledge about osteoarthritis.	baseline, 3 months and 6 months post baseline
Fear of Movement [Mechanistic Outcome]	This will be measured by the Brief Fear of Movement Scale for Osteoarthritis. Total scores range from 6 to 24, where higher scores indicate greater fear of movement and a worse outcome.	baseline, 3 months and 6 months post baseline
Psychological distress [Mechanistic Outcome]	This will be measured by the Four-Dimensional Symptom Questionnaire (4DSQ). The distress subscale scores range from 0 to 32, where higher scores indicate higher psychological distress.	baseline, 3 months and 6 months post baseline
Family support [Mechanistic Outcome]	This will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS), a validated 12-item questionnaire designed to measure perceived social support from family. Total scores range from 12 to 84, where higher scores indicate better perceived social support and a better outcome. In addition to the MSPSS, a study-specific questionnaire will be used.	baseline, 3 months and 6 months post baseline

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: National University Hospital, Singapore; University of the Sunshine Coast

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: August 11, 2026
• First Submitted That Met QC Criteria: August 11, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: knee osteoarthritis; mHealth; mobile application; self-directed rehabilitation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Singapore General Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the completion of the trial, de-identified individual participant data may be shared with qualified researchers upon request under a data-sharing agreement. Data released for secondary analyses will be further reviewed and redacted as necessary to protect participant privacy and confidentiality. All participants will be assigned a unique study ID and will not be identifiable by name. The data-sharing agreement will include provisions to safeguard participant privacy and data confidentiality.
• IPD Sharing Time Frame: The data will be available starting 6 months after primary study publication.
• IPD Sharing Access Criteria: Data will be made available upon reasonable written request to the study team. The PI, Dr. Yong-Hao Pua will review requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No