Wearable Sensors in Knee OA (WESENS-OA)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Exercise-based Physical Therapy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: Boston University; Eli Lilly and Company; Pfizer

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2020
• Primary Completion (ACTUAL): November 15, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (ACTUAL): January 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; gait; physical therapy; wearable sensors; pain sensitization
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 5540E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in publication(s), after deidentification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following publication(s).
• IPD Sharing Access Criteria: Data will only be shared for individual participant data meta-analyses. Data will be shared with investigators who propose a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No