Wearable Sensors in Knee OA

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2022-11-04

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.

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm interventional study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Since this is a single-arm study, no masking is included.

Study Groups

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Exercise-based Physical Therapy

12 week in-person exercise-based physical therapy

Group Type EXPERIMENTAL

Exercise-based Physical Therapy

Intervention Type BEHAVIORAL

Exercises for pain modulation, strengthening, and neuromuscular control

Interventions

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Exercise-based Physical Therapy

Exercises for pain modulation, strengthening, and neuromuscular control

Intervention Type BEHAVIORAL

Other Intervention Names

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Exercise

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No