Wearable Sensors in Knee OA

NCT04243096

Last updated date
Study Location
Boston University
Boston, Massachusetts, 02215, United States
Contact
617-358-3037

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- ≥ 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Wearable Sensors in Knee OA
Official Title  ICMJE Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA)
Brief Summary This is a single-arm clinical trial to investigate wearable sensors for assessing outcomes following physical therapy in people with knee osteoarthritis.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Behavioral: Physical Therapy
Neuromuscular and strength training, OA education, pain education, manual therapy, and physical activity goal setting
Other Name: Exercise
Study Arms  ICMJE Experimental: Physical Therapy
12 week in-person exercise-based physical therapy
Intervention: Behavioral: Physical Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Deepak Kumar, PT, PhD617-358-3037[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04243096
Other Study ID Numbers  ICMJE Not Provided
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party Boston University Charles River Campus
Study Sponsor  ICMJE Boston University Charles River Campus
Collaborators  ICMJE
  • Boston University
  • Pfizer
Investigators  ICMJE
Principal Investigator:Deepak Kumar, PT, PhDBoston University
Principal Investigator:Tuhina Neogi, MD, PhDBoston University
PRS Account Boston University Charles River Campus
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP