Development and Randomized Controlled Trial of an AI-powered Technological Surrogate Physiotherapist (TSP) Dedicated to Quality Enhancement and Cost Reduction in Knee Osteoarthritis Exercise Rehabilitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The University of Hong Kong
- Enrollment
- 264
- Locations
- 1
- Primary Endpoint
- Changes in knee pain as assessed by a 11-point numerical pain rating scale as recommended by the OARSI
- Status
- Not yet recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
The goal of the study is to confirm the idea of AI-powered Technological Surrogate Physiotherapist (TSP), by demonstrating its effectiveness and value as a new technology-based contribution to OA healthcare. Participants will be randomized to one of three groups: (1) the conventional PT group receiving the exercise program delivered through in-person sessions; (2) the AI-guided group following the program through the TSP after an initial PT session; or (3) the combined group receiving both in-person PT sessions and AI-guided home exercise. All individuals will take part in the study for 12 weeks, and data will be collected at baseline and 12 weeks after randomization.
Detailed Description
Knee pain, often caused by osteoarthritis, is a prevalent musculoskeletal disorder among older adults and significantly reduces physical function and quality of life. Exercise therapy has been shown to be an effective form of treatment for knee pain. However, the traditional delivery of exercise therapy requires that individuals attend clinics to participate in face-to-face exercise sessions, which can be expensive and inconvenient. In recent years, information technologies have been used to support the delivery of exercise programs. The programs have also shown great benefits in improving the management of knee pain. However, it remains a concern that physical therapists are not able to provide the patients with direct and immediate supervision when exercises are taken place remotely at home or in community centers, which can be detrimental to exercise performance and the management of knee pain. Thus, the research team has developed a machine learning-based exercise training system to provide evidence-based lower limb exercise videos, real-time movement feedback, and tracking of exercise progress for older adults with knee pain. In this study, a 12-week randomized controlled non-inferiority trial will be conducted to examine the effects of AI-powered Technological Surrogate Physiotherapist, comparing with the effects of the group receiving in-person sessions and effects of the combined group receiving both.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants will be recruited if they
- •age ≥ 50 years,
- •report having pain in or around the knee for more than 12 weeks and on most days of the previous month,
- •report being diagnosed with knee OA by a physician, have physician-diagnosed knee OA in the medical record, or have radiographic evidence of grade 2 to 3 knee OA on the Kellgren-Lawrence scale in the posteroanterior and/or skyline view or the presence of lateral/posterior osteophytes (the X-rays will be read and classified by our orthopaedic surgeons collaborators to decide on each patient's eligibility to be included in the study),
- •are willing and physically and cognitively able to perform (technology-supported) exercises required in the study protocol
- •have normal or corrected to normal vision,
- •are able to speak and read Chinese,
- •are able to provide written informed consent.
Exclusion Criteria
- •Individuals will be excluded if they have
- •history of knee or hip replacement surgery,
- •non-ambulatory status,
- •systemic inflammatory arthritis (e.g., gout),
- •history of trauma (e.g., fractures around the knee, dislocation, and sprains or tears of soft tissues, like ligaments) or surgical arthroscopy of either knee within the past 6 months,
- •intra-articular injection to the knee within the past 6 months,
- •cognitive impairment,
- •involvement in a similar study in the past 6 months,
- •recent or imminent surgery (within 12 weeks),
- •medical co-morbidities that preclude participation in exercise.
Outcomes
Primary Outcomes
Changes in knee pain as assessed by a 11-point numerical pain rating scale as recommended by the OARSI
Time Frame: From baseline to 12 weeks
0 represents no pain and 10 represents the worst possible pain.
Changes in physical function as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) physical function sub-scale
Time Frame: From baseline to 12 weeks
The scale regards the degree of difficulty in performing usual daily activities and higher level activities that involve physical function of the knee. Each item will be rated on a 5-point Likert scale ranging from 'None' (i.e., no difficulty) to 'Extreme' (i.e., extreme difficulty), based on which a normalized total score will be calculated (0 indicating extreme symptoms and 100 indicating no symptoms).
Secondary Outcomes
- Changes in physical function as assessed by 30-second chair-stand test(From baseline to 12 weeks)
- Changes in physical function as assessed by timed up-and-go test(From baseline to 12 weeks)
- Changes in physical function as assessed by maximal isometric strength of the quadriceps and hamstrings(From baseline to 12 weeks)
- Changes in physical function as assessed by active and passive ranges of motion of the hip and knee joints(From baseline to 12 weeks)
- Changes in health-related quality of life assessed by the Chinese version of the 36-item Short Form Survey (SF-36)(From baseline to 12 weeks)
- Exercise adherence(From baseline to 12 weeks)
- Satisfaction with the therapeutic exercise training(From baseline to 12 weeks)
- Convenience in terms of location and time for accessing the exercise therapy(From baseline to 12 weeks)