Wearable Sensors in Knee OA (WESENS-OA)

• ClinicalTrials.gov Identifier: NCT04243096
• Recruitment Status: Active, not recruiting
• First Posted: January 28, 2020
• Last Update Posted: February 8, 2023
• Sponsor: Boston University Charles River Campus
• Collaborators: Boston University; Pfizer; Eli Lilly and Company
• Information provided by (Responsible Party): Deepak Kumar, Boston University Charles River Campus

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	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single-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: January 21, 2020
• Actual Primary Completion Date: November 15, 2022
• Estimated Study Completion Date: June 30, 2023

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 Name: Exercise

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. cadence [ Time Frame: Change from baseline to 12 weeks ]
   number of steps/min
2. gait speed [ Time Frame: Change from baseline to 12 weeks ]
   walking speed (m/s)
3. stride duration [ Time Frame: Change from baseline to 12 weeks ]
   duration of one stride during gait (sec)
4. step duration [ Time Frame: Change from baseline to 12 weeks ]
   duration of one step during gait (sec)
5. total double support time [ Time Frame: Change from baseline to 12 weeks ]
   time when both feet are on the ground in one gait cycle (sec)
6. single limb support time [ Time Frame: Change from baseline to 12 weeks ]
   time when one foot is on the ground in one gait cycle (sec)
7. stance time [ Time Frame: Change from baseline to 12 weeks ]
   duration of stance phase during gait (sec)
8. swing time [ Time Frame: Change from baseline to 12 weeks ]
   duration of swing phase during gait (sec)
9. step length [ Time Frame: Change from baseline to 12 weeks ]
   length of a step during gait (m)
10. duration of sit to stand [ Time Frame: Change from baseline to 12 weeks ]
    time taken to complete a chair stand (sec)
11. sit to stand acceleration [ Time Frame: Change from baseline to 12 weeks ]
    peak acceleration during chair stand (m/s^2)
12. sit to stand deceleration [ Time Frame: Change from baseline to 12 weeks ]
    peak deceleration during chair stand (m/s^2)
13. knee index [ Time Frame: Change from baseline to 12 weeks ]
    knee loading index from 3D motion capture (Nm/%bodyweight-height)
14. knee co-contraction [ Time Frame: Change from baseline to 12 weeks ]
    cocontraction index from surface electromyography (no units)
15. knee frontal plane excursion [ Time Frame: Change from baseline to 12 weeks ]
    abduction-adduction range during stance phase of gait measured using 3D motion capture (degrees)
16. knee sagittal plane excursion [ Time Frame: Change from baseline to 12 weeks ]
    flexion-extension range during stance phase of gait measured using 3D motion capture (degrees)
17. trunk angle [ Time Frame: Change from baseline to 12 weeks ]
    peak trunk forward flexion angle during stance phase of gait measured using 3D motion capture (degrees)
18. Global Assessment [ Time Frame: Change from baseline to 12 weeks ]
    Patient Global Assessment of OA (PGA-OA) (range 1-5, higher score indicates worse outcome)
19. Step Up Test [ Time Frame: Change from baseline to 12 weeks ]
    number of step ups completed in 15 seconds
20. SCT [ Time Frame: Change from baseline to 12 weeks ]
    time taken to go up and down a flight of stairs (sec)
21. SPPB [ Time Frame: Change from baseline to 12 weeks ]
    Short Physical Performance Battery total score
22. 6MWT [ Time Frame: Change from baseline to 12 weeks ]
    distance covered walking in 6 minutes (m)
23. 5STS [ Time Frame: Change from baseline to 12 weeks ]
    time taken to complete 5 chair stands (sec)

Other Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Boston University

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Boston University Charles River Campus

Boston University

Pfizer

Eli Lilly and Company

Investigators

• Principal Investigator: Deepak Kumar, PT, PhD; Boston University
• Principal Investigator: Tuhina Neogi, MD, PhD; Boston University

More Information

• Responsible Party: Deepak Kumar, Assistant Professor, Boston University Charles River Campus
• ClinicalTrials.gov Identifier: NCT04243096
• Other Study ID Numbers: 5540E
• First Posted: January 28, 2020
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in publication(s), after deidentification.
• Supporting Materials: Study Protocol
• Time Frame: Beginning 9 months and ending 36 months following publication(s).
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deepak Kumar, Boston University Charles River Campus:

physical therapy; wearable sensors; gait; pain sensitization; physical activity

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases