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Wearable Sensors in Knee OA (WESENS-OA)

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise-based Physical Therapy
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring physical therapy, wearable sensors, gait, pain sensitization, physical activity

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise-based Physical Therapy

Arm Description

12 week in-person exercise-based physical therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2020
Last Updated
February 6, 2023
Sponsor
Boston University Charles River Campus
Collaborators
Boston University, Pfizer, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04243096
Brief Title
Wearable Sensors in Knee OA
Acronym
WESENS-OA
Official Title
Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
Boston University, Pfizer, Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
physical therapy, wearable sensors, gait, pain sensitization, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm interventional study
Masking
None (Open Label)
Masking Description
Since this is a single-arm study, no masking is included.
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise-based Physical Therapy
Arm Type
Experimental
Arm Description
12 week in-person exercise-based physical therapy
Intervention Type
Behavioral
Intervention Name(s)
Exercise-based Physical Therapy
Other Intervention Name(s)
Exercise
Intervention Description
Exercises for pain modulation, strengthening, and neuromuscular control
Primary Outcome Measure Information:
Title
gait bouts
Description
number of gait bouts per day measured using lumbar sensor
Time Frame
Change from baseline to 12 weeks
Title
number of sit to stand
Description
number of chair stands per day measured using lumbar sensor
Time Frame
Change from baseline to 12 weeks
Title
MVPA
Description
time spent in moderate and vigorous intensity activity per day
Time Frame
Change from baseline to 12 weeks
Title
Knee pain- KOOS Pain
Description
Knee injury and Osteoarthritis Outcome Scale Pain Score (0-100, higher score indicate better outcome)
Time Frame
Change from baseline to 12 weeks
Title
Patient-reported Function- KOOS ADL
Description
Knee injury and Osteoarthritis Outcome Scale ADL Score (0-100, higher score indicate better outcome)
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
cadence
Description
number of steps/min
Time Frame
Change from baseline to 12 weeks
Title
gait speed
Description
walking speed (m/s)
Time Frame
Change from baseline to 12 weeks
Title
stride duration
Description
duration of one stride during gait (sec)
Time Frame
Change from baseline to 12 weeks
Title
step duration
Description
duration of one step during gait (sec)
Time Frame
Change from baseline to 12 weeks
Title
total double support time
Description
time when both feet are on the ground in one gait cycle (sec)
Time Frame
Change from baseline to 12 weeks
Title
single limb support time
Description
time when one foot is on the ground in one gait cycle (sec)
Time Frame
Change from baseline to 12 weeks
Title
stance time
Description
duration of stance phase during gait (sec)
Time Frame
Change from baseline to 12 weeks
Title
swing time
Description
duration of swing phase during gait (sec)
Time Frame
Change from baseline to 12 weeks
Title
step length
Description
length of a step during gait (m)
Time Frame
Change from baseline to 12 weeks
Title
duration of sit to stand
Description
time taken to complete a chair stand (sec)
Time Frame
Change from baseline to 12 weeks
Title
sit to stand acceleration
Description
peak acceleration during chair stand (m/s^2)
Time Frame
Change from baseline to 12 weeks
Title
sit to stand deceleration
Description
peak deceleration during chair stand (m/s^2)
Time Frame
Change from baseline to 12 weeks
Title
knee index
Description
knee loading index from 3D motion capture (Nm/%bodyweight-height)
Time Frame
Change from baseline to 12 weeks
Title
knee co-contraction
Description
cocontraction index from surface electromyography (no units)
Time Frame
Change from baseline to 12 weeks
Title
knee frontal plane excursion
Description
abduction-adduction range during stance phase of gait measured using 3D motion capture (degrees)
Time Frame
Change from baseline to 12 weeks
Title
knee sagittal plane excursion
Description
flexion-extension range during stance phase of gait measured using 3D motion capture (degrees)
Time Frame
Change from baseline to 12 weeks
Title
trunk angle
Description
peak trunk forward flexion angle during stance phase of gait measured using 3D motion capture (degrees)
Time Frame
Change from baseline to 12 weeks
Title
Global Assessment
Description
Patient Global Assessment of OA (PGA-OA) (range 1-5, higher score indicates worse outcome)
Time Frame
Change from baseline to 12 weeks
Title
Step Up Test
Description
number of step ups completed in 15 seconds
Time Frame
Change from baseline to 12 weeks
Title
SCT
Description
time taken to go up and down a flight of stairs (sec)
Time Frame
Change from baseline to 12 weeks
Title
SPPB
Description
Short Physical Performance Battery total score
Time Frame
Change from baseline to 12 weeks
Title
6MWT
Description
distance covered walking in 6 minutes (m)
Time Frame
Change from baseline to 12 weeks
Title
5STS
Description
time taken to complete 5 chair stands (sec)
Time Frame
Change from baseline to 12 weeks
Other Pre-specified Outcome Measures:
Title
total sleep time
Description
total sleep time per day measured using wrist-worn sensor (minutes)
Time Frame
Change from baseline to 12 weeks
Title
sleep interference
Description
Daily Sleep Interference Scale (DSIS) (0-10 numeric rating scale, higher number indicates greater interference in sleep due to pain)
Time Frame
Change from baseline to 12 weeks
Title
Peak extensor isometric torque
Description
peak extensor muscle torque from isometric strength testing (Nm/kg)
Time Frame
Change from baseline to 12 weeks
Title
Pressure Pain Threshold (PPT)
Description
pressure at which pain is initially felt (kg/m2)
Time Frame
Change from baseline to 12 weeks
Title
temporal summation (TS)
Description
presence of wind up phenomenon in response to multiple pressure stimuli (yes/no)
Time Frame
Change from baseline to 12 weeks
Title
conditioned pain modulation (CPM)
Description
reduction in pain sensitivity with application of second pain stimulus (yes/no)
Time Frame
Change from baseline to 12 weeks
Title
knee pain
Description
Numeric rating scale for pain (0-10, higher score indicates worse pain)
Time Frame
Change from baseline to 12 weeks
Title
knee pain during nominated activity
Description
Numeric rating scale for pain during nominated activity (0-10, higher score indicates worse pain)
Time Frame
Change from baseline to 12 weeks
Title
Symptoms - KOOS symptoms
Description
Knee injury and osteoarthritis outcome score Symptoms scale (0-100, higher scores indicates better outcome)
Time Frame
Change from baseline to 12 weeks
Title
QOL - KOOS QOL
Description
Knee injury and osteoarthritis outcome score quality of life scale (0-100, higher scores indicates better outcome)
Time Frame
Change from baseline to 12 weeks
Title
S/R - KOOS S/R
Description
Knee injury and osteoarthritis outcome score sports/recreation scale (0-100, higher scores indicates better outcome)
Time Frame
Change from baseline to 12 weeks
Title
depressive symptoms
Description
Center for Epidemiologic Studies Depression Scale (range 0-60, higher score indicate more depressive symptoms)
Time Frame
Change from baseline to 12 weeks
Title
number of painful joints
Description
number of painful joints in the body
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak Kumar, PT, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tuhina Neogi, MD, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Wearable Sensors in Knee OA

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