Wearable Sensors in Knee OA (WESENS-OA)

Boston University Charles River Campus

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Behavioral: Exercise-based Physical Therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04243096

5540E

Details and patient eligibility

About

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.

Full description

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.

Enrollment

62 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.