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

NCT ID: NCT06167304

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2025-08-31

Brief Summary

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.

Conditions

Knee Osteoarthritis; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Technology-implemented exercise therapy

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Traditional Physical Therapy

Intervention Type: OTHER

Traditional physical therapy per Standard of care.

Interventions

Technology-implemented exercise therapy

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

Intervention Type: OTHER

Traditional Physical Therapy

Traditional physical therapy per Standard of care.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Laura Tabacof

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Tabacof

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Abilities Research Center

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-22-01430

Identifier Type: -

Identifier Source: org_study_id