WESENS-OA: Wearable Sensors in Knee OA

Sponsor

Boston University Charles River Campus (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04243096

Collaborator

Boston University (Other), Pfizer (Industry), Eli Lilly and Company (Industry)

Enrollment

Location

Arm

33.8

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Behavioral: Exercise-based Physical Therapy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single-arm interventional studySingle-arm interventional study

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 21, 2020

Anticipated Primary Completion Date :

Nov 15, 2022

Anticipated Study Completion Date :

Nov 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise-based Physical Therapy 12 week in-person exercise-based physical therapy	Behavioral: Exercise-based Physical Therapy Exercises for pain modulation, strengthening, and neuromuscular control Other Names: Exercise

Arm

Intervention/Treatment

Experimental: Exercise-based Physical Therapy

12 week in-person exercise-based physical therapy

Behavioral: Exercise-based Physical Therapy

Exercises for pain modulation, strengthening, and neuromuscular control

Other Names:

Exercise

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

total sleep time [Change from baseline to 12 weeks]
total sleep time per day measured using wrist-worn sensor (minutes)
sleep interference [Change from baseline to 12 weeks]
Daily Sleep Interference Scale (DSIS) (0-10 numeric rating scale, higher number indicates greater interference in sleep due to pain)
Peak extensor isometric torque [Change from baseline to 12 weeks]
peak extensor muscle torque from isometric strength testing (Nm/kg)
Pressure Pain Threshold (PPT) [Change from baseline to 12 weeks]
pressure at which pain is initially felt (kg/m2)
temporal summation (TS) [Change from baseline to 12 weeks]
presence of wind up phenomenon in response to multiple pressure stimuli (yes/no)
conditioned pain modulation (CPM) [Change from baseline to 12 weeks]
reduction in pain sensitivity with application of second pain stimulus (yes/no)
knee pain [Change from baseline to 12 weeks]
Numeric rating scale for pain (0-10, higher score indicates worse pain)
knee pain during nominated activity [Change from baseline to 12 weeks]
Numeric rating scale for pain during nominated activity (0-10, higher score indicates worse pain)
Symptoms - KOOS symptoms [Change from baseline to 12 weeks]
Knee injury and osteoarthritis outcome score Symptoms scale (0-100, higher scores indicates better outcome)
QOL - KOOS QOL [Change from baseline to 12 weeks]
Knee injury and osteoarthritis outcome score quality of life scale (0-100, higher scores indicates better outcome)
S/R - KOOS S/R [Change from baseline to 12 weeks]
Knee injury and osteoarthritis outcome score sports/recreation scale (0-100, higher scores indicates better outcome)
depressive symptoms [Change from baseline to 12 weeks]
Center for Epidemiologic Studies Depression Scale (range 0-60, higher score indicate more depressive symptoms)
number of painful joints [Change from baseline to 12 weeks]
number of painful joints in the body

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.