LLM-Guided Rehabilitation in Degenerative Knee Disease

NCT07267962 | Active Not Recruiting

• 1 other identifier: 2025/1056
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenerative Knee Disease

Keywords

Degenerative knee disease; physiotherapy; rehabilitation; large language model; ChatGPT; DeepSeek; Gemini

Outcome Measures

Primary Outcomes (1)

• Change 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.

  Baseline (week 0) to end of treatment (week 8)

Secondary Outcomes (14)

• 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

Study Arms (4)

Conventional physiotherapy

ACTIVE COMPARATOR

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).

Biological: Supervised conventional physiotherapy

Conventional physiotherapy plus ChatGPT-5-assisted exercise planning

EXPERIMENTAL

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).

Behavioral: ChatGPT-5-assisted exercise planning

Conventional physiotherapy plus DeepSeek V3.1-assisted exercise planning

EXPERIMENTAL

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).

Behavioral: DeepSeek V3.1-assisted exercise planning

Conventional physiotherapy plus Gemini 2.5 Pro-assisted exercise planning

EXPERIMENTAL

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).

Behavioral: Gemini 2.5 Pro-assisted exercise planning

Interventions

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.

Conventional physiotherapy plus ChatGPT-5-assisted exercise planning

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.

Conventional physiotherapy plus DeepSeek V3.1-assisted exercise planning

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.

Conventional physiotherapy plus Gemini 2.5 Pro-assisted exercise planning

Supervised conventional physiotherapy BIOLOGICAL

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).

Conventional physiotherapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, Merez, 40100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Lecturer

Model Details: Four-arm, parallel-group randomized controlled trial in adults with degenerative knee disease.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)