Wearable Sensors in Knee OA

Study Overview
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Brief Summary
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This is a single-arm clinical trial to investigate the outcome of exercise-based physical therapy in people with knee osteoarthritis through the use of wearable sensors.

Detailed Description
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This is a longitudinal, single arm, 19-week study to investigate the utility of digital assessments to measure the efficacy of exercise-based physical therapy (PT) for reducing pain and improving function in people with knee osteoarthritis (OA). A total of 60 participants will be included. Participants will receive a supervised exercise-based PT for 12 weeks and will undergo multiple assessments of strength, balance, gait and joint movement while being monitored with a motion capture system and wrist and lumbar wearable sensors. Additionally, participants' activities will be monitored in the real world with the same wrist and lumbar wearable sensors. After completion of the PT program, participants will be monitored for an additional 6-week period to measure persistence of treatment effect. During that time, they will continue to follow an exercise program at home. The primary objective will be to measure the effect of exercise-based PT on functional performance and pain reduction using both patient reported outcomes questionnaires (PROs) and digital metrics obtained from the laboratory assessments and wearable sensors worn in the real world. Pain phenotyping questionnaires and quantitative sensory testing assessments will also be used to evaluate the effect of specific pain phenotypes in treatment response. A substudy will be undertaken to assess reproducibility of sensor-based measures during physical performance testing across at-home and in-lab implementation, as well as, reproducibility of these measures over repeated at-home implementation.

Official Title
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Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA)

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Exercise-based Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 50 years of age A confirmed clinical diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria (confirmed by the participant's physician). Score ≥ 3 on weight-bearing questions from the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale in the index knee BMI ≤ 40 kg/m2 Able to walk without assisted devices (eg. cane or walker) for at least 20 minutes Can speak and understand English Available for the study duration Exclusion Criteria: Contraindication to exercise Other pain in lower back or legs that is greater than knee pain Currently receiving chemotherapy or radiation therapy for cancer except non-melanoma skin cancer History of other disease that may involve the index joint including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), crystalline disease (eg, gout or pseudogout), lupus erythematosus, knee joint infections, Paget's disease affecting the knee, or knee joint tumors. Any knee surgery in the previous 6 months Previous knee osteotomy, uni-compartmental replacement, or total knee replacement in either knee Joint replacement in either hip or ankle Planned major treatment for knee OA (e.g., surgery, injections, physical therapy) during the study period Planned major surgery in the next 6 months Corticosteroid or hyaluronic acid injections in either knee in the previous 3 months Neurological conditions that impacts motor functioning, for e.g., stroke, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc. Pregnant Received physical therapy for knee OA within past 6 months Known or suspected non-compliance, drug or alcohol abuse Participation in another clinical trial for treatment of any joint or muscle pain Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigators.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise-based Physical Therapy<br>12 week in-person exercise-based physical therapy | Behavioral: Exercise-based Physical Therapy<br>* Exercises for pain modulation, strengthening, and neuromuscular control<br>* Other names: Exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gait bouts | number of gait bouts per day measured using lumbar sensor | Change from baseline to 12 weeks | 
| number of sit to stand | number of chair stands per day measured using lumbar sensor | Change from baseline to 12 weeks | 
| MVPA | time spent in moderate and vigorous intensity activity per day | Change from baseline to 12 weeks | 
| Knee pain- KOOS Pain | Knee injury and Osteoarthritis Outcome Scale Pain Score (0-100, higher score indicate better outcome) | Change from baseline to 12 weeks | 
| Patient-reported Function- KOOS ADL | Knee injury and Osteoarthritis Outcome Scale ADL Score (0-100, higher score indicate better outcome) | Change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cadence | number of steps/min | Change from baseline to 12 weeks | 
| gait speed | walking speed (m/s) | Change from baseline to 12 weeks | 
| stride duration | duration of one stride during gait (sec) | Change from baseline to 12 weeks | 
| step duration | duration of one step during gait (sec) | Change from baseline to 12 weeks | 
| total double support time | time when both feet are on the ground in one gait cycle (sec) | Change from baseline to 12 weeks | 
| single limb support time | time when one foot is on the ground in one gait cycle (sec) | Change from baseline to 12 weeks | 
| stance time | duration of stance phase during gait (sec) | Change from baseline to 12 weeks | 
| swing time | duration of swing phase during gait (sec) | Change from baseline to 12 weeks | 
| step length | length of a step during gait (m) | Change from baseline to 12 weeks | 
| duration of sit to stand | time taken to complete a chair stand (sec) | Change from baseline to 12 weeks | 
| sit to stand acceleration | peak acceleration during chair stand (m/s^2) | Change from baseline to 12 weeks | 
| sit to stand deceleration | peak deceleration during chair stand (m/s^2) | Change from baseline to 12 weeks | 
| knee index | knee loading index from 3D motion capture (Nm/%bodyweight-height) | Change from baseline to 12 weeks | 
| knee co-contraction | cocontraction index from surface electromyography (no units) | Change from baseline to 12 weeks | 
| knee frontal plane excursion | abduction-adduction range during stance phase of gait measured using 3D motion capture (degrees) | Change from baseline to 12 weeks | 
| knee sagittal plane excursion | flexion-extension range during stance phase of gait measured using 3D motion capture (degrees) | Change from baseline to 12 weeks | 
| trunk angle | peak trunk forward flexion angle during stance phase of gait measured using 3D motion capture (degrees) | Change from baseline to 12 weeks | 
| Global Assessment | Patient Global Assessment of OA (PGA-OA) (range 1-5, higher score indicates worse outcome) | Change from baseline to 12 weeks | 
| Step Up Test | number of step ups completed in 15 seconds | Change from baseline to 12 weeks | 
| SCT | time taken to go up and down a flight of stairs (sec) | Change from baseline to 12 weeks | 
| SPPB | Short Physical Performance Battery total score | Change from baseline to 12 weeks | 
| 6MWT | distance covered walking in 6 minutes (m) | Change from baseline to 12 weeks | 
| 5STS | time taken to complete 5 chair stands (sec) | Change from baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy, wearable sensors, gait, pain sensitization, physical activity