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Completed

NCT Number: NCT07267962

LLM-Guided Rehabilitation in Degenerative Knee Disease

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.

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Key information

Conditions

Degenerative Knee Disease

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırşehir Ahi Evran University

Kırşehir, Merez, 40100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Supervised conventional physiotherapy

Behavioral

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).

ChatGPT-5-assisted exercise planning

Behavioral

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.

DeepSeek V3.1-assisted exercise planning

Behavioral

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.

Gemini 2.5 Pro-assisted exercise planning

Behavioral

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.

Primary outcomes

  1. Change in KOOS total score

    Time frame: Baseline (week 0) to end of treatment (week 8)

    Knee Injury and Osteoarthritis Outcome Score (KOOS) total score (0-100), calculated as the mean of the five KOOS subscales (Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and knee-related Quality of Life). Higher scores indicate better knee-related health. The primary analysis will compare change in KOOS total score from baseline to week 8 between the four groups.

Secondary outcomes

  1. Change in knee pain intensity at rest, at night and during activity (Numeric Pain Rating Scale)

    Time frame: Baseline (week 0) to week 8

    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.

  2. Change in IKDC subjective knee score

    Time frame: Baseline (week 0) to week 8

    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.

  3. Change in Lysholm knee score

    Time frame: Baseline (week 0) to week 8

    Lysholm knee score (0-100). Higher scores indicate better knee function. Change from baseline to week 8 will be analyzed between the four groups.

  4. Change in 30-second chair stand test performance

    Time frame: Baseline (week 0) to week 8

    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.

  5. Change in Four Square Step Test performance

    Time frame: Baseline (week 0) to week 8

    Four Square Step Test (FSST): the time (seconds) taken to step sequentially over four canes arranged in a cross, moving forward, sideways, and backward. Lower times indicate better dynamic balance and functional mobility. Change in completion time from baseline to week 8 will be compared between groups.

  6. Change in stair climb test time

    Time frame: Baseline (week 0) to week 8

    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.

  7. Change in maximal isometric quadriceps strength

    Time frame: Baseline (week 0) to week 8

    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.

  8. Change in maximal isometric hamstring strength

    Time frame: Baseline (week 0) to week 8

    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.

  9. Change in knee range of motion

    Time frame: Baseline (week 0) to week 8

    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.

  10. Change in Pain Catastrophizing Scale score

    Time frame: Baseline (week 0) to week 8

    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.

  11. Change in Tampa Scale for Kinesiophobia score

    Time frame: Baseline (week 0) to week 8

    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.

  12. Change in SF-12 physical and mental component summary scores

    Time frame: Baseline (week 0) to week 8

    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.

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

The Effect of ChatGPT-5, Gemini 2.5 Pro, and DeepSeek V3.1 Guided Rehabilitation on Clinical Outcomes in Individuals With Degenerative Knee Disease

Acronym: LLM-RehabKnee

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.