Physical Therapy vs Remote Exercise for Knee Pain Due to Osteoarthritis (OA)

Study Purpose

The purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with SimpleTherapy, participants with clinical indications of knee OA will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens.

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	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adults (age ≥ 18 years) - Living in the tristate area - CT/NY/NJ.

- Symptomatic OA (National Institute for Health and Care Excellence clinical criteria for OA) - Chronic knee pain (>3 months) as a primary pain complaint.

- Average pain score ≥ 4 on an 11-point numeric rating scale at baseline.

- Access to a device with internet connection.

- KL Stages 1-2-3.

Exclusion Criteria:

- Prior documented history of cognitive impairment; - History of total knee arthroplasty; - History of: Inflammatory arthritis (e.g. rheumatoid arthritis); or any neuropathies affecting the lower limbs, spinal cord injury, spine fractures, advanced heart disease, bleeding issues (i.e. hemophilia), surgery within the last 90 days; fall within 90 days; high risk of fracture; - History of knee injury, within the last 3 months; - Currently engaged with other PT or strengthening program; - Present unstable/uncontrolled cardiovascular condition.

- Undergoing active chemotherapy for cancer

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.	NCT06167304
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.	Icahn School of Medicine at Mount Sinai
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Laura Tabacof
Principal Investigator Affiliation	Icahn School of Medicine at Mount Sinai
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis, Chronic Pain

Arms & Interventions

Arms

Experimental: Technology-implemented exercise therapy

Therapy plans performed at home overseen by a remote physical therapist via SimpleTherapy. Allocation to this group will require using smart devices or a computer/laptop to receive care. Remote visits with a PT typically last 45min long and home exercises suggested by the app are self-paced.

Active Comparator: Traditional Physical Therapy

Participants will be prescribed an exercise plan by a physical therapist as normally would occur as part of standards of care outside the context of a research study. In-person assessments and at-home exercise suggestions will be decided by the physical therapist. Duration of PT appointments is typically 45 minutes long two times per week and are supplemented by PT recommended self-paced at-home exercises.

Interventions

Other: - Technology-implemented exercise therapy

Therapy plans are performed at home overseen by a remote physical therapist via SimpleTherapy.

Other: - Traditional Physical Therapy

Traditional physical therapy per Standard of care.

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.

Abilities Research Center, New York, New York

Status

Recruiting

Address

Abilities Research Center

New York, New York, 10029

Site Contact

Sophia I Salazar, BSc

[email protected]

212-241-8454

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