Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||50 Years and Over|
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.
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.
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|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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
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.