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: 176
• 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 two groups: (1) the conventional PT group receiving the exercise program delivered through in-person sessions; or (2) the AI-guided group following the program through the TSP after an initial PT session. 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 (6)

• 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

• Exercise adherence

  From baseline to 12 weeks

• Satisfaction with the therapeutic exercise training

  From baseline to 12 weeks

Study Arms (2)

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

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

Eligibility Criteria

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

You may qualify if:

• At least 50 years of age;
• Report having knee pain most days of the week;
• Has radiographic evidence of grade 2, 3, or 4 knee OA on the K-L scale in the posteroanterior and/or skyline view in at least 1 knee;
• Willing and able, both physically and cognitively, to perform the exercises required in the study protocol;
• Has normal or corrected-to-normal vision;
• Able to speak Cantonese and read Chinese, AND
• Able to provide written informed consent.

You may not qualify if:

• Having a history of knee or hip replacement surgery;
• Being nonambulatory;
• Having systemic inflammatory arthritis (e.g., gout);
• Having a history of trauma (e.g., fractures around the knee, dislocation, sprains or tears of soft tissues like ligaments) or surgical arthroscopy of either knee within the past 6 months;
• Having intra-articular injection to the knee within the past 6 months;
• Having cognitive impairment;
• Involvement in a similar study (i.e., involving physical exercise or physical therapies for knee pain) within the past 6 months;
• Undergoing recent or imminent surgery (within 3 months) , OR
• Having 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: May 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)