Effects of a Machine Learning-based Lower Limb Exercise Training System for Knee Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
The AI-powered Technological Surrogate Physiotherapist
DeviceThe 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.
Face-to-face physiotherapist-supervised exercise program
BehavioralPhysiotherapists 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.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: The AI-powered Technological Surrogate PhysiotherapistExperimental treatment 1 intervention
Group B: Face-to-face physiotherapist-supervised exercise programActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline to 12 weeks2
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).
Time frame
From baseline to 12 weeksSecondary outcomes
1
Changes in physical function as assessed by 30-second chair-stand test
30-second chair stand test (30CST), which measures the number of stands the participant can complete in 30 sec, will be used to assess the general leg strength and functional performance.
Time frame
From baseline to 12 weeks2
Changes in physical function as assessed by timed up-and-go test
Timed up and go (TUG) test, which measures the time it takes the participant to standup from the chair, walk 3 meters, walk back to the chair, and sit down, will be used to assess functional mobility.
Time frame
From baseline to 12 weeks3
Changes in physical function as assessed by maximal isometric strength of the quadriceps and hamstrings
The participant will be instructed to maximally extend/flex each knee for 3 trials, 3 sec each, with a 1-minute rest in between. Verbal encouragement will be given in each trial to ensure the participant makes the maximum effort. The highest force of each muscle in the three trials will be used for data analysis. After each test trial, the severity of pain experienced by the participant during the trial will be assessed using the 11-point numerical pain rating scale.
Time frame
From baseline to 12 weeks4
Exercise adherence
Exercise adherence will be indicated by the proportion of sessions and proportion of exercises performed which will be recorded by the TSP system (only for intervention group) and by participants and researchers using a log book.
Time frame
From baseline to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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