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).

- 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
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


- 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.

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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 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.

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: Exercise-based Physical Therapy
Exercises for pain modulation, strengthening, and neuromuscular control
Other Name: Exercise
Study Arms  ICMJE Experimental: Exercise-based Physical Therapy
12 week in-person exercise-based physical therapy
Intervention: Behavioral: Exercise-based 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date May 31, 2022   (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).
  • 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.
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 5540E
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: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.
Responsible Party Deepak Kumar, Boston University Charles River Campus
Study Sponsor  ICMJE Boston University Charles River Campus
Collaborators  ICMJE
  • Boston University
  • Pfizer
  • Eli Lilly and Company
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 December 2020

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