Formative Evaluation of a Mobile Application Facilitated Self-directed Rehabilitation Programme for Knee Osteoarthritis

NCT07773480 | Not Yet Recruiting

• 1 other identifier: 2024-4180
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after using the mobile application

Secondary Outcomes (17)

• Gait speed

  Pre-intervention; 12 weeks after using the mobile application

• Knee range-of-motion

  Pre-intervention; 12 weeks after using the mobile application

• Incidental and planned exercise (IPEQ)

  12 weeks after using the mobile application

• Health-related quality of life

  Pre-intervention; 12 weeks after using the mobile application

• Muscle strength

  Pre-intervention; 12 weeks after using the mobile application

Other Outcomes (11)

• Education

  Pre-intervention

• Race

  Pre-intervention

• Co-morbidities

  Pre-intervention

Study Arms (1)

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

Device: Self-directed rehabiliation using the mobile application

Interventions

Self-directed rehabiliation using the mobile application DEVICE

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

Self-directed rehabilitation using the mobile application

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ee Lin Woon

CONTACT

81253463; woon.ee.lin@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: August 19, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-05

Locations

SG (1)