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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Changes in knee pain as assessed by a 11-point numerical pain rating scale as recommended by the OARSI
研究概览
简要总结
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 two groups: (1) the conventional PT group receiving the exercise program delivered through in-person sessions; or (2) the AI-guided group following the program through the TSP after an initial PT session. All individuals will take part in the study for 12 weeks, and data will be collected at baseline and 12 weeks after randomization.
详细描述
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 compare the effects of the AI-powered Technological Surrogate Physiotherapist with those of in-person physiotherapy sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 50 years of age;
- •Report having knee pain most days of the week;
- •Has radiographic evidence of grade 2, 3, or 4 knee OA on the K-L scale in the posteroanterior and/or skyline view in at least 1 knee;
- •Willing and able, both physically and cognitively, to perform the exercises required in the study protocol;
- •Has normal or corrected-to-normal vision;
- •Able to speak Cantonese and read Chinese, AND
- •Able to provide written informed consent.
排除标准
- •Having a history of knee or hip replacement surgery;
- •Being nonambulatory;
- •Having systemic inflammatory arthritis (e.g., gout);
- •Having a history of trauma (e.g., fractures around the knee, dislocation, sprains or tears of soft tissues like ligaments) or surgical arthroscopy of either knee within the past 6 months;
- •Having intra-articular injection to the knee within the past 6 months;
- •Having cognitive impairment;
- •Involvement in a similar study (i.e., involving physical exercise or physical therapies for knee pain) within the past 6 months;
- •Undergoing recent or imminent surgery (within 3 months) , OR
- •Having medical co-morbidities that preclude participation in exercise.
研究组 & 干预措施
The AI-powered Technological Surrogate Physiotherapist Plus Face-to-face physiotherapist-supervised
Participants will receive an integrated intervention combining conventional physiotherapist-supervised sessions and TSP-supported home exercises (three 30-minute exercise sessions per week for 12 weeks).
干预措施: The AI-powered Technological Surrogate Physiotherapist Plus Face-to-face physiotherapist-supervised exercise program (Combination Product)
The AI-powered Technological Surrogate Physiotherapist
Participants will be required to perform three 30-minute exercise sessions per week for 12 weeks, with six exercises at any one time. During the exercise sessions, participants will receiveTechnological Surrogate Physiotherapist (TSP) support which will in particular leverage AI to offer innovative features and modules dedicated to enhancing exercise monitoring and supervision, real-time performance feedback, and self-assessment.
干预措施: The AI-powered Technological Surrogate Physiotherapist (Device)
Face-to-face physiotherapist-supervised exercise program
Participants will be required to visit a physiotherapist for usual face-to-face exercise therapy. Also, they will be required to perform three 30-minute home exercise sessions per week for 12 weeks. However, TSP will not be involved in this group.
干预措施: Face-to-face physiotherapist-supervised exercise program (Behavioral)
结局指标
主要结局
Changes in knee pain as assessed by a 11-point numerical pain rating scale as recommended by the OARSI
时间窗: 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
时间窗: 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).
次要结局
- 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)