AzTrials
AzTrials

Knee OsteoarthristisMOKneeTORNCT07767409

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

A study testing MOKneeTOR with standard app configuration, Hospital-based outpatient rehabilitation program and MOKneeTOR with standard app configuration and enhanced personalisation in people with Knee Osteoarthristis, run by Singapore General Hospital at 1 site in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 95 years
Conditions the study is for
Knee Osteoarthristis
What is being tested?
MOKneeTOR with standard app configuration, Hospital-based outpatient rehabilitation program and MOKneeTOR with standard app configuration and enhanced personalisation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSingapore
Study dates
18 Jun 2026to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yong Hao Pua, PhD contact

90575437

pua.yong.hao@sgh.com.sg

Singapore1 site, 1 recruiting
  • Singapore General Hospital

    Singapore

    Yong Hao Pua, PhD, 90575437, pua.yong.hao@sgh.com.sg

    Recruiting

Other trials in Singapore

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
MOKneeTOR with standard app configuration, Hospital-based outpatient rehabilitation program, MOKneeTOR with standard app configuration and enhanced personalisation
Keywords
knee osteoarthritis, mobile application, self-directed rehabilitation, mHealth
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOKneeTOR with standard app configurationDevice

    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.

  • Hospital-based outpatient rehabilitation programOther

    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.

  • MOKneeTOR with standard app configuration and enhanced personalisationDevice

    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.

Study groups in NCT07767409
Study groupRoleWhat they receive
Hospital-based outpatient rehabilitation programActive comparatorParticipants 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.
Receives: Other: Hospital-based outpatient rehabilitation program
MOKneeTOR with standard app configurationExperimentalMOKneeTOR 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.
Receives: Device: MOKneeTOR with standard app configuration
MOKneeTOR with standard app configuration and enhanced personalisationExperimentalMOKneeTOR 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.
Receives: Device: MOKneeTOR with standard app configuration and enhanced personalisation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, 3 months and 6 months post baseline visit

Secondary outcomes (12)
  1. 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.

    Measured: baseline, 3 months and 6 months post baseline

  2. 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.

    Measured: baseline, 3 months and 6 months post baseline

  3. Knee strength

    Maximum quadriceps strength will be assessed on a seated knee extension machine using a standardized one repetition maximum (1RM) protocol.

    Measured: baseline, 3 months and 6 months post baseline

  4. 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.

    Measured: baseline, 3 months and 6 months post baseline

  5. 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.

    Measured: baseline, 3 months and 6 months post baseline

  6. 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".

    Measured: 3 months post baseline

  7. 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."

    Measured: 3 months post baseline

  8. 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".

    Measured: 3 months post baseline

  9. 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).

    Measured: 3 months post baseline

  10. Exercise Compliance

    Participants will report their knee strenghtening exercise frequency (days per week).

    Measured: 3 months and 6 months post baseline

  11. 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).

    Measured: 3 months and 6 months post baseline

  12. 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.

    Measured: 3 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start18 Jun 2026
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07767409
Sponsor's protocol ID
Singapore General Hospital
Acronym
MOKneeTOR
Status last verified
Oct 2026
First submitted
11 Aug 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing MOKneeTOR with standard app configuration, Hospital-based outpatient rehabilitation program and MOKneeTOR with standard app configuration and enhanced personalisation in people with Knee Osteoarthristis, run by Singapore General Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yong Hao Pua, PhD (90575437, pua.yong.hao@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait speed (time frame: baseline, 3 months and 6 months post baseline visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in