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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Supervised outpatient physiotherapy including hot pack (20 minutes), conventional TENS (100 Hz, 60 µs, 20 minutes), therapeutic ultrasound (1 MHz, 1.5 W/cm², 5 minutes) and a standardized knee exercise program (strengthening, range of motion, proprioceptive and functional exercises), delivered two times per week for 8 weeks (16 sessions in total).
Exercise selection and progression for the knee rehabilitation program supported by standardized prompts to the ChatGPT-5 large language model. All LLM-generated suggestions are reviewed for safety and appropriateness by physiotherapists before being implemented in supervised sessions.
Exercise selection and progression for the knee rehabilitation program supported by standardized prompts to the DeepSeek V3.1 large language model. All LLM-generated suggestions are reviewed for safety and appropriateness by physiotherapists before being implemented in supervised sessions.
Exercise selection and progression for the knee rehabilitation program supported by standardized prompts to the Gemini 2.5 Pro large language model. All LLM-generated suggestions are reviewed for safety and appropriateness by physiotherapists before being implemented in supervised sessions.
Kırşehir Ahi Evran University
Kırşehir, Merez, Turkey (Türkiye)
RECRUITINGChange in WOMAC total score
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.
Time frame: Baseline (week 0) to end of treatment (week 8)
Change in knee pain intensity at rest, at night and during activity (Numeric Pain Rating Scale)
Numeric Pain Rating Scale (0-10) scores for knee pain at rest, at night and during activity. Higher scores indicate more severe pain. Mean change in each pain condition from baseline to week 8 will be compared between groups.
Time frame: Baseline (week 0) to week 8
Change in IKDC subjective knee score
International Knee Documentation Committee (IKDC) subjective knee form score (0-100). Higher scores indicate better symptoms, sports activity and knee function. Change from baseline to week 8 will be compared between groups.
Time frame: Baseline (week 0) to week 8
Change in Lysholm knee score
Lysholm knee score (0-100). Higher scores indicate better knee function. Change from baseline to week 8 will be analyzed between the four groups.
Time frame: Baseline (week 0) to week 8
Change in 30-second chair stand test performance
Number of full stands completed in 30 seconds from a standard chair. Higher numbers indicate better lower limb functional performance. Change in repetitions from baseline to week 8 will be compared between groups.
Time frame: Baseline (week 0) to week 8
Change in fast walking test time
Time (seconds) required to complete a fast walking test over a fixed distance (e.g., 4 × 10 m or 40 m, according to the study protocol). Lower times indicate better performance. Change in time from baseline to week 8 will be analyzed.
Time frame: Baseline (week 0) to week 8
Change in stair climb test time
Time (seconds) needed to ascend and/or descend a standardized set of stairs. Lower times indicate better functional performance. Change from baseline to week 8 will be compared between groups.
Time frame: Baseline (week 0) to week 8
Change in maximal isometric quadriceps strength
Maximal voluntary isometric strength of the quadriceps muscle of the target knee, measured with a handheld dynamometer. Higher values (e.g., Newtons) indicate greater muscle strength. Change from baseline to week 8 will be compared between groups.
Time frame: Baseline (week 0) to week 8
Change in maximal isometric hamstring strength
Maximal voluntary isometric strength of the hamstring muscles of the target limb, measured with a handheld dynamometer. Higher values indicate greater muscle strength. Change from baseline to week 8 will be compared between groups.
Time frame: Baseline (week 0) to week 8
Change in knee range of motion
Active knee flexion and extension range of motion measured with a universal goniometer in degrees. Higher flexion and closer-to-zero extension deficit indicate better joint mobility. Changes in range of motion from baseline to week 8 will be analyzed.
Time frame: Baseline (week 0) to week 8
Change in Pain Catastrophizing Scale score
Pain Catastrophizing Scale total score (0-52). Higher scores indicate greater levels of pain catastrophizing. Change from baseline to week 8 will be compared between groups.
Time frame: Baseline (week 0) to week 8
Change in Tampa Scale for Kinesiophobia score
Tampa Scale for Kinesiophobia total score (17-68). Higher scores indicate greater fear of movement or re-injury. Change from baseline to week 8 will be analyzed between groups.
Time frame: Baseline (week 0) to week 8
Change in Hospital Anxiety and Depression Scale - Anxiety subscale score
Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale score (0-21). Higher scores indicate higher anxiety symptoms. Change from baseline to week 8 will be compared between groups.
Time frame: Baseline (week 0) to week 8
Change in Hospital Anxiety and Depression Scale - Depression subscale score
Hospital Anxiety and Depression Scale (HADS) - Depression subscale score (0-21). Higher scores indicate higher depressive symptoms. Change from baseline to week 8 will be analyzed between groups.
Time frame: Baseline (week 0) to week 8
Change in SF-12 physical and mental component summary scores
Short Form-12 (SF-12) physical and mental component summary scores (0-100). Higher scores indicate better health-related quality of life. Change from baseline to week 8 will be compared between groups.
Time frame: Baseline (week 0) to week 8
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