Wearable Sensors in Knee OA

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04243096
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boston University Charles River Campus
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Deepak Kumar, PT, PhDTuhina Neogi, MD, PhD
Principal Investigator Affiliation Boston UniversityBoston University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherIndustry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Physical Therapy

12 week in-person exercise-based physical therapy

Interventions

Behavioral: - Physical Therapy

Neuromuscular and strength training, OA education, pain education, manual therapy, and physical activity goal setting

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston University, Boston, Massachusetts

Status

Address

Boston University

Boston, Massachusetts, 02215