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Wearable Sensors in Knee OA (WESENS-OA)

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ClinicalTrials.gov Identifier: NCT04243096
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborators:
Boston University
Pfizer
Information provided by (Responsible Party):
Boston University Charles River Campus

Brief Summary:
This is a single-arm clinical trial to investigate wearable sensors for assessing outcomes following physical therapy in people with knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Behavioral: Physical Therapy Not Applicable

Detailed Description:

This is a longitudinal, single arm, interventional, 19-week study to investigate the utility of digital assessments to measure the efficacy of physical therapy for reducing pain and improving function in people with knee osteoarthritis. A total of 60 participants will be included. Participants will receive a supervised in-clinic physical therapy program for 12 weeks and will undergo multiple laboratory functional 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 at home with the same wrist and lumbar wearable sensors. After completion of the physical therapy program, there will be an additional 6-week monitoring period to measure persistence of the treatment effect during which time participants will continue to follow an exercise program at home. Outcomes will be assessed at baseline, 6 week, 12 weeks, and 18 weeks.

The primary objective will be to measure the effect of physical therapy on functional performance and pain using both patient reported outcomes questionnaires and digital metrics obtained from the laboratory assessments and wearable sensors worn at home. Pain phenotyping questionnaires and quantitative sensory testing assessments will be used to evaluate the effect of specific pain phenotypes in treatment response.

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Therapy
12 week in-person exercise-based physical therapy
Behavioral: Physical Therapy
Neuromuscular and strength training, OA education, pain education, manual therapy, and physical activity goal setting
Other Name: Exercise




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. gait symmetry [ Time Frame: Change from baseline to 12 weeks ]
    gait symmetry 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. sit to stand speed [ Time Frame: Change from baseline to 12 weeks ]
    time taken to complete a sit to stand task measured using lumbar sensor


Secondary Outcome Measures :
  1. knee index [ Time Frame: Change from baseline to 12 weeks ]
    knee loading index from 3D motion capture (Nm/%bodyweight-height)

  2. knee co-contraction [ Time Frame: Change from baseline to 12 weeks ]
    cocontraction index from surface electromyography (no units)

  3. 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)

  4. Participant-reported Pain [ Time Frame: Change from baseline to 12 weeks ]
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (range 0-20, higher score indicates worse pain)

  5. Participant-reported Function [ Time Frame: Change from baseline to 12 weeks ]
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function score (range 0-68, higher score indicates worse function)

  6. 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)

  7. 30STS [ Time Frame: Change from baseline to 12 weeks ]
    In-lab 30 second sit to stand test counts

  8. 40FPW [ Time Frame: Change from baseline to 12 weeks ]
    In-lab 40 meter fast paced walk test (sec)

  9. SCT [ Time Frame: Change from baseline to 12 weeks ]
    In-lab stair climbing test (sec)

  10. SPPB [ Time Frame: Change from baseline to 12 weeks ]
    In-lab Short Physical Performance Battery

  11. gait speed [ Time Frame: Change from baseline to 12 weeks ]
    gait speed measured using lumbar sensor (m/s)


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. Pain catastrophizing [ Time Frame: Change from baseline to 12 weeks ]
    Pain catastrophizing scale (range 0-52, higher score indicate worse outcome)

  6. neuropathic pain [ Time Frame: Change from baseline to 12 weeks ]
    PainDETECT (range 0-32, score over 18 indicates presence of neuropathic pain)

  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. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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).
  • WOMAC Pain subscale NRS ≥ 4 (on a 0-10 scale) in the index knee
  • BMI ≤ 40 kg/m2
  • Able to walk unassisted for at least 20 minutes
  • Can speak and understand English
  • Available for the study duration
  • Own a smartphone

Exclusion Criteria:

  • Contraindication to exercise
  • Other pain in lower back or legs that is greater than knee pain
  • Cancer being treated 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), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget's disease, or tumors.
  • Any knee surgery in the previous 6 months
  • Previous knee osteotomy, uni-compartmental replacement, or total knee replacement in either knee
  • Total joint replacement in any lower extremity joint
  • Planned major treatment for knee OA (e.g., surgery, injections, physical therapy) during the study period
  • 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
  • Use assistive devices (such as a cane or walker) at home
  • Known or suspected non-compliance, drug or alcohol abuse
  • Participation in another clinical trial
  • Persons 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243096


Contacts
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Contact: Deepak Kumar, PT, PhD 617-358-3037 kumard@bu.edu

Locations
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United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University Charles River Campus
Boston University
Pfizer
Investigators
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Principal Investigator: Deepak Kumar, PT, PhD Boston University
Principal Investigator: Tuhina Neogi, MD, PhD Boston University
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Responsible Party: Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT04243096    
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University Charles River Campus:
physical therapy
wearable sensors
gait
pain sensitization
physical activity
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases