Knee OsteoarthritisNCT07773480
Formative Evaluation of a Mobile Application Facilitated Self-directed Rehabilitation Programme for Knee Osteoarthritis
A study testing Self-directed rehabiliation using the mobile application in people with Knee Osteoarthritis, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
In Singapore, knee osteoarthritis (OA) is a prevalent musculoskeletal condition, reflecting global trends of an aging population and lifestyle factors. With Singapore's rapidly aging population and the rising prevalence of obesity and sedentary lifestyles, knee OA has become increasingly common. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Self-directed rehabiliation using the mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Aug 2026to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the National Institute for Health and Care Excellence (NICE) osteoarthritis clinical criteria (7)
- aged 45 years and over
- activity related knee joint pain
- morning stiffness ≤30 min
- History of knee pain on most days for ≥3 months
- Able to give informed consent and to participate fully in the interventions and assessment procedures
- Has a smartphone and be willing to use it during the study.
- Able to share photos/ videos with other phone contacts using smartphone
Who cannot join
- Patients who meet any of the exclusion criteria mentioned below will be excluded from participation.
- Rheumatoid arthritis and other systemic arthritis
- A previous history of stroke and other major neurological conditions
- An intention to undergo knee joint replacement surgery or have had a knee joint replacement
- Has significant back or other non-knee pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
Singapore General Hospital
Singapore
Ee Lin Woon, 81253463, woon.ee.lin@sgh.com.sg
About this study
Official title: Formative Evaluation of a Mobile Application Facilitated Self-Directed Rehabilitation Programme for the Conservative Management of Knee Osteoarthritis
In Singapore, knee osteoarthritis (OA) is a prevalent musculoskeletal condition, reflecting global trends of an aging population and lifestyle factors. With Singapore's rapidly aging population and the rising prevalence of obesity and sedentary lifestyles, knee OA has become increasingly common. According to recent studies, symptomatic OA of the knee affects around one-fifth (~300K) of Singaporeans aged 50 years or older. Individuals with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. While knee replacement surgery is an effective option for severe knee OA, it is costly and there are risks of complications, and should only be considered when all appropriate non-surgical treatment options have been exhausted. Existing research suggests at least a quarter of knee replacements could have been avoided through more optimal conservative treatments.
Despite established healthcare systems and treatment pathways, studies in several settings report that the majority of patients with OA do not receive appropriate and optimal medical care. In Singapore, several factors such as cost, extended wait times, cultural factors and travel inconvenience pose barriers to accessing physiotherapy services. These factors hinder patients' ability to access care resulting in suboptimal care, poor outcomes, and needless economic burden. Thus, there is a large unmet need for innovative and flexible strategies to deliver effective conservative management and treatment for knee OA widely and at a relatively low cost.
Read more
Solutions that empower individuals and allow for self-directed rehabilitation without the need for real-time human supervision could be the key to improve effectiveness, accessibility and reduce the reliance on healthcare manpower. Given the prevalence of mobile phone, mobile applications offer a promising avenue for delivering self-directed rehabilitation programs to adults with knee OA. Previous self-directed rehabilitation programs for patients with knee OA have shown promise, however, the adoption and adherence to these programmes remain low, particularly among older adults who may not be technologically savvy. Developing an application that is tailored to the needs and capabilities of older adults with knee osteoarthritis is crucial to improve engagement and long-term adherence to the programme.
The investigators have previously developed a technology-enabled self-directed rehabilitation program for patients who have undergone TKR for primary knee OA. Subsequently, Managing Osteoarthritis of the knee using Therapist-Technology Optimized Rehabilitation (MO-knee-TOR) - a standalone mobile app to facilitate self-directed rehabilitation and complement a "blended" care approach involving an initial face-to-face session with the physiotherapist was developed. MO-knee-TOR was developed for patients with TKR and subsequently evaluated in 2 pilot randomised controlled trials (RCTs). In one of the RCTs, it was found that self-directed rehabilitation post TKR facilitated using the mobile application improved exercise adherence without compromising safety and clinical outcomes. In this current proposal, MO-knee-TOR is adapted for conservative knee OA management through a single-arm pre-post feasibility study with a nested qualitative component.
- Conditions
- Knee Osteoarthritis
- Being tested
- Self-directed rehabiliation using the mobile application
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-directed rehabiliation using the mobile applicationDevice
Participants will be instructed on the installation and use of the mobile application on their personal mobile phones during their first outpatient physiotherapy session. Participants will then have to perform the assigned tasks using the mobile application for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Self-directed rehabilitation using the mobile application | Experimental | Participants will be instructed on the installation and use of the mobile application on their personal mobile phones. Participants will then have to perform the assigned tasks using the mobile application for 12 weeks Receives: Device: Self-directed rehabiliation using the mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
The feasibility of evaluating the prototype in a larger trial will be assessed using predefined progression criteria including, including recruitment and retention rates, adherence to the program, incidence of adverse events, and improvement in function. Progression will be guided using thresholds categorized as "proceed," "proceed with protocol amendments," or "significant amendments required" based on the criteria defined for each feasibility domain.
Measured: 12 weeks after using the mobile application
Secondary outcomes (17)
Gait speed
Gait speed will be measured from walking a distance of 4m at comfortable pace and 9m at fast pace with a 2m acceleration and deceleration zone before and after the timed section of 9m.
Measured: Pre-intervention; 12 weeks after using the mobile application
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
Measured: Pre-intervention; 12 weeks after using the mobile application
Incidental and planned exercise (IPEQ)
This is a tool developed to measure physical activity, distinguishing between incidental exercise (activities that are not planned but contribute to overall physical activity, like walking to work or taking the stairs) and planned exercise (deliberate, structured exercise like going to the gym or running)
Measured: 12 weeks after using the mobile application
Health-related quality of life
The EQ5D-5L is a standardised instrument to measure health related quality of life in cost-effectiveness analysis
Measured: Pre-intervention; 12 weeks after using the mobile application
Muscle strength
Isotonic quadriceps strength will be determined using the one-repetition maximum test, which is the maximum load the patient could lift once in good form. A submaximal warm-up was provided by instructing the patient to perform bilateral knee extension at < 10 kgs. The range of-motion for the test was set from 90° to 40° of knee flexion to avoid the increased patellofemoral joint stress associated with terminal knee extension
Measured: Pre-intervention; 12 weeks after using the mobile application
Handgrip strength test
Participants' grip strength will be measured using Jamar hand dynamometer
Measured: Pre-intervention; 12 weeks after using the mobile application
Weight bearing symmetry
This assesses the ability of the participants to weight bear on their limb. With their feet on 2 portable force plates, participants will stand up from a standard chair, and weight-bearing symmetry is calculated by expressing the peak force produced by the operated leg as a percentage of that produced by the unoperated leg.
Measured: Pre-intervention; 12 weeks after using the mobile application
5-repetition-sit-to-stand test
A test to assess participants' ability to rise from a chair and return to the sitting position. The time taken for participant to stan up and sit down five times as fast as posible from standard chair (43-47cm) without the use of their hands will be recorded. This test is a measure that is performed as part of standard clinical practice and is also a measure of lower limb strength and dynamic balance.
Measured: Pre-intervention; 12 weeks after using the mobile application
Physical function
Participants will report their physical function using the Short Modified Arthritis Measure for Function (Short-MAC-F), which assesses difficulty in performing common daily activities related to knee function, including stair negotiation, rising from sitting, walking on a flat surface, getting in and out of a car, and dressing. Each item is rated on a 5-point Likert scale, where 0 indicates "none" and 4 indicates "extreme" difficulty. Higher scores indicate greater functional limitation.
Measured: Pre-intervention; 12 weeks after using the mobile application
Treatment satisfaction
Participants will rate their satisfaction with the rehabilitation programme using the prototype on a 11 point Likert scale, with 0 indicating "no satisfaction" and 10 indicating "complete satisfaction".
Measured: 12 weeks after using the mobile application
Exercise Compliance/Adherence
Self-reported compliance will be collected by asking participants how many times they completed their exercises. Compliance will also be determined from the data logs captured by the mobile application.
Measured: 12 weeks after using the mobile application
Brief Fear of Movement
Participants will report their fear of movement related to knee osteoarthritis using the Brief Fear of Movement Scale (BFOM). The scale consists of multiple statements assessing beliefs about movement, injury, and pain. Each item is rated on a 4-point Likert scale, where 1 indicates "strongly disagree" and 4 indicates "strongly agree."
Measured: Pre-intervention; 12 weeks after using the mobile application
Psychological distress
Four-dimensional symptom questionnaire (4DSQ) will be used to assess psychological distress, anxiety, depression and
Measured: Pre-intervention; 12 weeks after using the mobile application
Perceived Need for Knee Replacement Surgery
Participants will rate how necessary they perceive knee replacement surgery for their condition based on knee symptoms over the past week using an 11-point numeric rating scale from 0 to 10 (allowing increments of 0.5), where 0 indicates "not at all necessary" and 10 indicates "totally necessary." Participants will also provide a categorical rating of perceived necessity, ranging from "not at all necessary" to "totally necessary." Higher scores indicate a greater perceived need for knee replacement surgery.
Measured: Pre-intervention; 12 weeks after using the mobile application
Pain
Participants will rate their knee pain intensity during specific activities using a Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates "no pain" and 11 indicates "worst imaginable pain." Higher scores indicate greater pain intensity.
Measured: Pre-intervention; 12 weeks after using the mobile application
Participant Experience and Perceptions (Exit Interview)
Participants will attend an exit interview session at study completion to evaluate their experiences and perceptions of using the mobile application and force platforms for self-directed rehabilitation.
Qualitative data will be collected through guided interviews, recorded, and analyzed thematically to assess usability, acceptability, and user experience. Findings from these interviews will be used to inform refinements to optimize the application design and overall user experience.
Measured: 12 weeks after using the mobile application
Physical Function
Participants will provide an overall rating of their knee condition using a global rating scale reflecting their perception of their knee and associated problems. Higher scores indicate greater perceived severity of impairment.
Measured: Pre-intervention; 12 weeks after using the mobile application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773480
- Sponsor's protocol ID
- 2024-4180
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Evaluation of a Mobile Application Facilitated Self-Directed Rehabilitation Programme for the Conservative Management of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07773480
- Acronym / sponsor ID
- 2024-4180
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Singapore, knee osteoarthritis (OA) is a prevalent musculoskeletal condition, reflecting global trends of an aging population and lifestyle factors. With Singapore's rapidly aging population and the rising prevalence of obesity and sedentary lifestyles, knee OA has become increasingly common. According to recent studies, symptomatic OA of the knee affects around one-fifth (~300K) of Singaporeans aged 50 years or older. Individuals with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. While knee replacement surgery is an effective option for severe knee OA, it is costly and there are risks of complications, and should only be considered when all appropriate non-surgical treatment options have been exhausted. Existing research suggests at least a quarter of knee replacements could have been avoided through more optimal conservative treatments.
Despite established healthcare systems and treatment pathways, studies in several settings report that the majority of patients with OA do not receive appropriate and optimal medical care. In Singapore, several factors such as cost, extended wait times, cultural factors and travel inconvenience pose barriers to accessing physiotherapy services. These factors hinder patients' ability to access care resulting in suboptimal care, poor outcomes, and needless economic burden. Thus, there is a large unmet need for innovative and flexible strategies to deliver effective conservative management and treatment for knee OA widely and at a relatively low cost.
Solutions that empower individuals and allow for self-directed rehabilitation without the need for real-time human supervision could be the key to improve effectiveness, accessibility and reduce the reliance on healthcare manpower. Given the prevalence of mobile phone, mobile applications offer a promising avenue for delivering self-directed rehabilitation programs to adults with knee OA. Previous self-directed rehabilitation programs for patients with knee OA have shown promise, however, the adoption and adherence to these programmes remain low, particularly among older adults who may not be technologically savvy. Developing an application that is tailored to the needs and capabilities of older adults with knee osteoarthritis is crucial to improve engagement and long-term adherence to the programme.
The investigators have previously developed a technology-enabled self-directed rehabilitation program for patients who have undergone TKR for primary knee OA. Subsequently, Managing Osteoarthritis of the knee using Therapist-Technology Optimized Rehabilitation (MO-knee-TOR) - a standalone mobile app to facilitate self-directed rehabilitation and complement a "blended" care approach involving an initial face-to-face session with the physiotherapist was developed. MO-knee-TOR was developed for patients with TKR and subsequently evaluated in 2 pilot randomised controlled trials (RCTs). In one of the RCTs, it was found that self-directed rehabilitation post TKR facilitated using the mobile application improved exercise adherence without compromising safety and clinical outcomes. In this current proposal, MO-knee-TOR is adapted for conservative knee OA management through a single-arm pre-post feasibility study with a nested qualitative component.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-directed rehabilitation using the mobile application | Experimental | Device: Self-directed rehabiliation using the mobile applicationParticipants will be instructed on the installation and use of the mobile application on their personal mobile phones. Participants will then have to perform the assigned tasks using the mobile application for 12 weeks |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet the National Institute for Health and Care Excellence (NICE) osteoarthritis clinical criteria (7)
- aged 45 years and over
- activity related knee joint pain
- morning stiffness ≤30 min
- History of knee pain on most days for ≥3 months
Key exclusion criteria (5 listed)
- Patients who meet any of the exclusion criteria mentioned below will be excluded from participation.
- Rheumatoid arthritis and other systemic arthritis
- A previous history of stroke and other major neurological conditions
- An intention to undergo knee joint replacement surgery or have had a knee joint replacement
- Has significant back or other non-knee pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-directed rehabiliation using the mobile applicationParticipants will be instructed on the installation and use of the mobile application on their personal mobile phones during their first outpatient physiotherapy session. Participants will then have to perform the assigned tasks using the mobile application for 12 weeks | Device | Self-directed rehabilitation using the mobile application |
Primary outcome
Feasibility
Time frame: 12 weeks after using the mobile application
The feasibility of evaluating the prototype in a larger trial will be assessed using predefined progression criteria including, including recruitment and retention rates, adherence to the program, incidence of adverse events, and improvement in function. Progression will be guided using thresholds categorized as "proceed," "proceed with protocol amendments," or "significant amendments required" based on the criteria defined for each feasibility domain.
17 secondary outcomes
Gait speed
Time frame: Pre-intervention; 12 weeks after using the mobile application
Knee range-of-motion
Time frame: Pre-intervention; 12 weeks after using the mobile application
Incidental and planned exercise (IPEQ)
Time frame: 12 weeks after using the mobile application
Health-related quality of life
Time frame: Pre-intervention; 12 weeks after using the mobile application
Muscle strength
Time frame: Pre-intervention; 12 weeks after using the mobile application
Handgrip strength test
Time frame: Pre-intervention; 12 weeks after using the mobile application
Weight bearing symmetry
Time frame: Pre-intervention; 12 weeks after using the mobile application
5-repetition-sit-to-stand test
Time frame: Pre-intervention; 12 weeks after using the mobile application
Physical function
Time frame: Pre-intervention; 12 weeks after using the mobile application
Treatment satisfaction
Time frame: 12 weeks after using the mobile application
Exercise Compliance/Adherence
Time frame: 12 weeks after using the mobile application
Brief Fear of Movement
Time frame: Pre-intervention; 12 weeks after using the mobile application
Psychological distress
Time frame: Pre-intervention; 12 weeks after using the mobile application
Perceived Need for Knee Replacement Surgery
Time frame: Pre-intervention; 12 weeks after using the mobile application
Pain
Time frame: Pre-intervention; 12 weeks after using the mobile application
Participant Experience and Perceptions (Exit Interview)
Time frame: 12 weeks after using the mobile application
Physical Function
Time frame: Pre-intervention; 12 weeks after using the mobile application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-directed rehabiliation using the mobile application in people with Knee Osteoarthritis, 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 8 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: opening soon, as of the sponsor's last update on 19 Aug 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 Ee Lin Woon (81253463, woon.ee.lin@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 12 weeks after using the mobile application). 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 19 Aug 2026.