The Effect of ChatGPT-5, Gemini 2.5 Pro, and DeepSeek V3.1 Guided Rehabilitation on Clinical Outcomes in Individuals With Degenerative Knee Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in WOMAC total score
研究概览
简要总结
This randomized, four-arm clinical trial will investigate the effects of large language model (LLM)-assisted exercise prescriptions integrated with conventional physiotherapy on pain, function and quality of life in adults with degenerative knee disease. Participants will be randomly assigned to conventional physiotherapy alone or to conventional physiotherapy plus an exercise program planned with the assistance of ChatGPT-5, Gemini 2.5 Pro, or DeepSeek V3.1. All participants will receive supervised outpatient physiotherapy two times per week for 8 weeks (16 sessions in total). Outcomes will be assessed at baseline and at the end of the 8-week intervention period by physiotherapists blinded to group allocation.
详细描述
Degenerative knee disease, including knee osteoarthritis, is a common cause of pain, disability and loss of independence in middle-aged and older adults. Exercise-based rehabilitation is a core component of evidence-based management, but the content and progression of exercise programs often vary between clinicians. Large language models (LLMs) such as ChatGPT-5, DeepSeek V3.1 and Gemini 2.5 Pro can generate exercise suggestions based on clinical information and may support physiotherapists in designing and progressing individualized programs. However, their impact on clinical outcomes in degenerative knee disease has not been evaluated in randomized controlled trials.
This single-center, randomized, parallel-group clinical trial will be conducted in adults with degenerative knee disease referred to the physiotherapy clinic of Kirsehir Ahi Evran University. After written informed consent and baseline assessments, participants will be randomly assigned (1:1:1:1) to one of four groups. All groups will receive a standardized outpatient physiotherapy program including hot pack, conventional TENS, therapeutic ultrasound and strengthening, range of motion, proprioceptive and functional exercises for the knee joint. In the three experimental groups, the content and progression of the exercise program will be planned with the assistance of standardized prompts to ChatGPT-5, DeepSeek V3.1 or Gemini 2.5 Pro, and all LLM-generated suggestions will be reviewed for safety and appropriateness by physiotherapists before being implemented. Sessions will be delivered two times per week for 8 weeks (16 supervised visits) under the supervision of a physical medicine and rehabilitation specialist and physiotherapists.
Outcomes will be evaluated at baseline (week 0) and after the 8-week intervention by a physiotherapist blinded to group allocation. Main outcome domains include knee pain, knee-related patient-reported outcomes, objective functional performance tests, isometric muscle strength, knee range of motion, psychosocial factors and health-related quality of life. Data will be analyzed according to CONSORT guidelines for randomized trials.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 65 years.
- •Clinical and radiographic diagnosis of degenerative knee disease in the target knee.
- •Knee pain in the target knee for at least 3 months.
- •Ability to bear weight on the target limb and perform the planned functional tests.
- •Sufficient cognitive and physical capacity to participate in an 8-week supervised exercise program.
- •Willingness to participate and ability to provide written informed consent.
排除标准
- •Intra-articular corticosteroid or similar injection to the target knee within the previous 3 months.
- •Knee surgery on the target knee within the previous 6 months.
- •Severe malalignment of the knee or concomitant severe neurological disease and/or balance disorder that would interfere with safe testing or exercise.
- •Pregnancy or any systemic disease that would contraindicate participation in the rehabilitation program according to the physician.
研究组 & 干预措施
Conventional physiotherapy
Participants receive supervised conventional physiotherapy including hot pack, TENS, ultrasound and a standardized knee exercise program two times per week for 8 weeks (16 sessions).
干预措施: Supervised conventional physiotherapy (Behavioral)
Conventional physiotherapy plus ChatGPT-5-assisted exercise planning
Participants receive supervised conventional physiotherapy plus an exercise program whose content and progression are planned with the assistance of the ChatGPT-5 large language model, under physiotherapist supervision, two times per week for 8 weeks (16 sessions).
干预措施: ChatGPT-5-assisted exercise planning (Behavioral)
Conventional physiotherapy plus DeepSeek V3.1-assisted exercise planning
Participants receive supervised conventional physiotherapy plus an exercise program whose content and progression are planned with the assistance of the DeepSeek V3.1 large language model, under physiotherapist supervision, two times per week for 8 weeks (16 sessions).
干预措施: DeepSeek V3.1-assisted exercise planning (Behavioral)
Conventional physiotherapy plus Gemini 2.5 Pro-assisted exercise planning
Participants receive supervised conventional physiotherapy plus an exercise program whose content and progression are planned with the assistance of the Gemini 2.5 Pro large language model, under physiotherapist supervision, two times per week for 8 weeks (16 sessions).
干预措施: Gemini 2.5 Pro-assisted exercise planning (Behavioral)
结局指标
主要结局
Change in WOMAC total score
时间窗: Baseline (week 0) to end of treatment (week 8)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score (0-96), composed of pain, stiffness and physical function subscales. Higher scores indicate worse symptoms and function. The primary analysis will compare change in WOMAC total score from baseline to week 8 between the four groups.
次要结局
- Change in Lysholm knee score(Baseline (week 0) to week 8)
- Change in maximal isometric quadriceps strength(Baseline (week 0) to week 8)
- Change in maximal isometric hamstring strength(Baseline (week 0) to week 8)
- Change in knee range of motion(Baseline (week 0) to week 8)
- Change in Pain Catastrophizing Scale score(Baseline (week 0) to week 8)
- Change in Tampa Scale for Kinesiophobia score(Baseline (week 0) to week 8)
- Change in Hospital Anxiety and Depression Scale - Anxiety subscale score(Baseline (week 0) to week 8)
- Change in knee pain intensity at rest, at night and during activity (Numeric Pain Rating Scale)(Baseline (week 0) to week 8)
- Change in IKDC subjective knee score(Baseline (week 0) to week 8)
- Change in 30-second chair stand test performance(Baseline (week 0) to week 8)
- Change in fast walking test time(Baseline (week 0) to week 8)
- Change in stair climb test time(Baseline (week 0) to week 8)
- Change in Hospital Anxiety and Depression Scale - Depression subscale score(Baseline (week 0) to week 8)
- Change in SF-12 physical and mental component summary scores(Baseline (week 0) to week 8)
- Change in Hospital Anxiety and Depression Scale - Depression subscale score(Baseline (week 0) to week 8)
- Change in SF-12 physical and mental component summary scores(Baseline (week 0) to week 8)
- Change in knee pain intensity at rest, at night and during activity (Numeric Pain Rating Scale)(Baseline (week 0) to week 8)
- Change in IKDC subjective knee score(Baseline (week 0) to week 8)
- Change in Lysholm knee score(Baseline (week 0) to week 8)
- Change in 30-second chair stand test performance(Baseline (week 0) to week 8)
- Change in fast walking test time(Baseline (week 0) to week 8)
- Change in stair climb test time(Baseline (week 0) to week 8)
- Change in maximal isometric quadriceps strength(Baseline (week 0) to week 8)
- Change in maximal isometric hamstring strength(Baseline (week 0) to week 8)
- Change in knee range of motion(Baseline (week 0) to week 8)
- Change in Pain Catastrophizing Scale score(Baseline (week 0) to week 8)
- Change in Tampa Scale for Kinesiophobia score(Baseline (week 0) to week 8)
- Change in Hospital Anxiety and Depression Scale - Anxiety subscale score(Baseline (week 0) to week 8)
研究者
Omer Alperen Gurses
Ph.D. Lecturer
Kirsehir Ahi Evran Universitesi