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.
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,
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,
Parallel
MOKneeTOR with standard app configuration
DeviceParticipants 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 program
Other interventionParticipants 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 personalisation
DeviceParticipants 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.
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.
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.
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.
Knee strength
Maximum quadriceps strength will be assessed on a seated knee extension machine using a standardized one repetition maximum (1RM) protocol.
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.
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.
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.
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).
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.
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Singapore General Hospital
Lead sponsor
National University Hospital, Singapore
Collaborator
University of the Sunshine Coast
Collaborator
