Wearable Sensors in Knee OA

Boston University Charles River Campus62 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Exercise-based Physical TherapyBEHAVIORAL

Exercises for pain modulation, strengthening, and neuromuscular control

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Boston University

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Sensor Derived Cadence

number of steps/min during the clinic-based 28-meter walk test from lower back sensor

Time frame: Change from baseline to 12 weeks

Sensor Derived Stride Duration

duration of one stride during gait (sec) during the clinic-based 28-meter walk test

Time frame: Change from baseline to 12 weeks

Sensor Derived Step Duration

duration of one step during gait (sec) during the clinic-based 28-meter walk test from lower back sensor

Time frame: Change from baseline to 12 weeks

Sensor Derived Stance Time

Duration of stance phase (i.e., duration of time the foot is in contact with the ground in a step) during gait (sec) during the clinic-based 28-meter walk test from lower back sensor

Time frame: Change from baseline to 12 weeks

Sensor Derived Total Double Support Time

time when both feet are on the ground in one gait cycle (sec) during the clinic-based 28-meter walk test from lower back sensor

Time frame: Change from baseline to 12 weeks

Sensor Derived Swing Time

duration of swing phase during gait (sec) during the clinic-based 28-meter walk test from lower back sensor

Time frame: Change from baseline to 12 weeks

Sensor Derived Single Limb Support Time

time when one foot is on the ground in one gait cycle (sec) during the clinic-based 28-meter walk test from lower back sensor

Time frame: Change from baseline to 12 weeks

Sensor Derived Step Length

Data from ClinicalTrials.gov

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Secondary Outcomes

Physical Function (KOOS ADL)

Knee injury and Osteoarthritis Outcome Scale ADL Score (0-100, higher score indicate better outcome)

Time frame: 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)

Time frame: Change from baseline to 12 weeks

Moderate to Vigorous Physical Activity (MVPA)

time spent in moderate and vigorous intensity activity per day extracted from a wrist worn sensor (GT9X Link)

Time frame: Change from baseline to 12 weeks

Time Taken to Complete 28-meter Walk Test

time taken to complete 28-meter walk test (s) from stopwatch during the clinic-based 28-meter walk test

Time frame: Change from baseline to 12 weeks

First Peak of Knee Index

Knee loading index for study knee during walking at self-selected pace from 3D motion capture (%Bodyweight\*height)

Time frame: Change from baseline to 12 weeks

Knee Co-contraction

Peak medial quadriceps-medial hamstrings co-contraction during loading response during walking at self-selected pace. Higher values reflect greater co-activation of these muscles.

Time frame: Change from baseline to 12 weeks

Knee Frontal Plane Excursion

abduction-adduction range during stance phase of gait measured using 3D motion capture (degrees)

Time frame: Change from baseline to 12 weeks

Knee Sagittal Plane Excursion

flexion-extension range for study knee during stance phase of gait measured during walking at self-selected pace using 3D motion capture (degrees)

Time frame: Change from baseline to 12 weeks

Trunk Angle

peak trunk forward flexion angle during sit-to-stand measured using 3D motion capture (degrees)

Time frame: Change from baseline to 12 weeks

Global Assessment

Patient Global Assessment of OA (PGA-OA) (range 0-100, higher score indicates better outcome)

Time frame: Change from baseline to 12 weeks

Step Up Test

number of step ups completed in 15 seconds

Time frame: Change from baseline to 12 weeks

Stair Climbing Test (SCT)

Time taken to go up and down a flight of stairs (sec)

Time frame: Change from baseline to 12 weeks

Short Physical Performance Battery (SPPB)

Short Physical Performance Battery total score. This is a functional test where several different activities (e.g., balance, walking, getting up from a chair) are performed and scored by the examiner. The total score is the sum of scores across all of the activities. Range is 0-12. Higher scores reflect better physical function.

Time frame: Change from baseline to 12 weeks

6-minute Walk Test (6MWT)

distance covered walking in 6 minutes (m)

Time frame: Change from baseline to 12 weeks

5-time Sit to Stand (5STS)

time taken to complete 5 chair stands (sec)

Time frame: Change from baseline to 12 weeks