Effects of a Machine Learning-based Lower Limb Exercise Training System for Knee Pain

NCT05173064 | Not Yet Recruiting

• 1 other identifier: Feedback System
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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 three groups: (1) the conventional PT group receiving the exercise program delivered through in-person sessions; (2) the AI-guided group following the program through the TSP after an initial PT session; or (3) the combined group receiving both in-person PT sessions and AI-guided home exercise. All individuals will take part in the study for 12 weeks, and data will be collected at baseline and 12 weeks after randomization.

Conditions

Pain; Knee Osteoarthritis

Keywords

knee pain, physical therapy, exercise

Outcome Measures

Primary Outcomes (2)

• Changes in knee pain as assessed by a 11-point numerical pain rating scale as recommended by the OARSI

  0 represents no pain and 10 represents the worst possible pain.

  From baseline to 12 weeks

• Changes in physical function as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) physical function sub-scale

  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).

  From baseline to 12 weeks

Secondary Outcomes (8)

• 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

Study Arms (3)

The AI-powered Technological Surrogate Physiotherapist

EXPERIMENTAL

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.

Device: The AI-powered Technological Surrogate Physiotherapist

Face-to-face physiotherapist-supervised exercise program

ACTIVE COMPARATOR

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.

Behavioral: Face-to-face physiotherapist-supervised exercise program

The AI-powered Technological Surrogate Physiotherapist Plus Face-to-face physiotherapist-supervised

EXPERIMENTAL

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).

Combination Product: The AI-powered Technological Surrogate Physiotherapist Plus Face-to-face physiotherapist-supervised exercise program

Interventions

The AI-powered Technological Surrogate Physiotherapist DEVICE

The AI-powered Technological Surrogate Physiotherapist will have three key features: 1. Evidence-based exercise videos instructed by physical therapists 2. Real-time movement feedback and performance score 3. Exercise records.

The AI-powered Technological Surrogate Physiotherapist

Face-to-face physiotherapist-supervised exercise program BEHAVIORAL

Physiotherapists will give usual face-to-face therapy. The assessment of participants' exercise movements will only be achieved in the traditional manner during face-to-face exercise sessions - by physiotherapists' visual inspection of and professional judgement on postural alignment and effectiveness, with verbal instructions for posture correction. The features of real-time movement feedback and tracking of exercise progress will not be provided.

Face-to-face physiotherapist-supervised exercise program

The AI-powered Technological Surrogate Physiotherapist Plus Face-to-face physiotherapist-supervised exercise program COMBINATION_PRODUCT

This group will attend in-person group therapy sessions, while additionally completing weekly home exercise sessions using the TSP system.

The AI-powered Technological Surrogate Physiotherapist Plus Face-to-face physiotherapist-supervised

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be recruited if they
• age ≥ 50 years,
• report having pain in or around the knee for more than 12 weeks and on most days of the previous month,
• report being diagnosed with knee OA by a physician, have physician-diagnosed knee OA in the medical record, or have radiographic evidence of grade 2 to 3 knee OA on the Kellgren-Lawrence scale in the posteroanterior and/or skyline view or the presence of lateral/posterior osteophytes (the X-rays will be read and classified by our orthopaedic surgeons collaborators to decide on each patient's eligibility to be included in the study),
• are willing and physically and cognitively able to perform (technology-supported) exercises required in the study protocol
• have normal or corrected to normal vision,
• are able to speak and read Chinese,
• are able to provide written informed consent.

You may not qualify if:

• Individuals will be excluded if they have
• history of knee or hip replacement surgery,
• non-ambulatory status,
• systemic inflammatory arthritis (e.g., gout),
• history of trauma (e.g., fractures around the knee, dislocation, and sprains or tears of soft tissues, like ligaments) or surgical arthroscopy of either knee within the past 6 months,
• intra-articular injection to the knee within the past 6 months,
• cognitive impairment,
• involvement in a similar study in the past 6 months,
• recent or imminent surgery (within 12 weeks),
• medical co-morbidities that preclude participation in exercise.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

826, Haking Wong Building, Pokfulam, The University of Hong Kong, Hong Kong

Hong Kong, 000, Hong Kong

Location

Related Publications (14)

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MeSH Terms

Conditions

Pain; Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Central Study Contacts

Calvin Kalun Or, PhD

CONTACT

(852) 3917-2587; klor@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 29, 2021
• Study Start: October 30, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)