Hospital-based Outpatient Physiotherapy Rehabilitation Versus Mobile Health (mHealth)-Based Exercise and Self-management in Patients With Symptomatic Knee Osteoarthritis

NCT07767409 | Recruiting

• 1 other identifier: Singapore General Hospital
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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 TKR 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 intervention. Physiotherapy rehabilitation incorporates these 3 first-line interventions and is a widely advocated and evidence-based component of OA intervention. 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. mHealth-based program is a likely solution to address this unmet need, but local contextualization is needed. Against this background, a mobile health (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 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, we 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 a mobile health (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.

Conditions

Knee Osteoarthristis

Keywords

knee osteoarthritis; mobile application; self-directed rehabilitation; mHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Short Form of the Western Ontario and McMaster Universities Osteoarthritis Index (ShortMAC F)

  baseline, 3 months and 6 months post baseline

• Knee Pain: Numeric Pain Rating Scale (NPRS)

  baseline, 3 months and 6 months post baseline

• Knee strength

  baseline, 3 months and 6 months post baseline

• Lower limb strength and mobility

  baseline, 3 months and 6 months post baseline

• Health-related quality of life - Euro Qol Group 5-Dimension (EQ-5D-5L)

  baseline, 3 months and 6 months post baseline

Other Outcomes (11)

• Adverse effects

  3 months and 6 months post baseline

• Body weight and overall muscle mass/strength measurements [Mechanistic Outcome]

  baseline, 3 months and 6 months post baseline

• Perceived TKR Necessity [Mechanistic Outcome]

  baseline, 3 months and 6 months post baseline

Study Arms (3)

Hospital-based outpatient rehabilitation program

ACTIVE COMPARATOR

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

MOKneeTOR with standard app configuration

EXPERIMENTAL

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

MOKneeTOR with standard app configuration and enhanced personalisation

EXPERIMENTAL

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

Interventions

Hospital-based outpatient rehabilitation program OTHER

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.

Hospital-based outpatient rehabilitation program

MOKneeTOR with standard app configuration and enhanced personalisation DEVICE

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.

MOKneeTOR with standard app configuration and enhanced personalisation

MOKneeTOR with standard app configuration DEVICE

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.

MOKneeTOR with standard app configuration

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: collaborator
• Singapore General Hospital: lead
• University of the Sunshine Coast: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Yong Hao Pua, PhD

CONTACT

90188129; pua.yong.hao@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because of the nature of the intervention, it is not feasible to blind participants or the treating physiotherapists. To reduce bias, the research assistant collecting assessment data will be blinded to treatment allocation. Participants will also be instructed not to reveal details about their group assignment to the outcome assessor to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Principal Physiotherapist

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available starting 6 months after primary study publication.
• Access Criteria: Data will be made available upon reasonable written request to the study team. The PI, Dr. Yong-Hao Pua will review requests.

Locations

SG (1)