Trials / Completed
CompletedNCT05114512
Rural Access to Physical Therapy for Osteoarthritis Rehabilitation - Pilot
Rural Access to Physical Therapy for Osteoarthritis Rehabilitation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- University of Pittsburgh · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
This is a pilot study involving a hybrid in-person + telerehabilitation intervention for rural adults with knee osteoarthritis. The primary purpose is to demonstrate feasibility and safety of the RAPTOR program, and the secondary purpose is to estimate clinical effectiveness of the RAPTOR program on participants' pain, function, and quality of life.
Detailed description
The purpose of the RAPTOR pilot study is to determine feasibility of a rural telerehabilitation intervention by assessing (1) attendance rate for telerehabilitation visits among participants in the pilot program; (2) participants satisfaction with the program; and (3) participant outcomes regarding pain, function, and quality of life. This pilot study will provide preliminary data to support efforts to obtain external funding for a future randomized trial comparing traditional physical therapy (PT) to the RAPTOR approach. The primary purpose of the RAPTOR pilot study is to demonstrate feasibility and safety of the RAPTOR program in rural adults with knee osteoarthritis (KOA). The secondary purpose is to estimate clinical effectiveness of the RAPTOR program on participants' pain, function, and health-related quality of life. This will enable the investigators to determine a sample size estimate for a future trial comparing RAPTOR to a traditional face-to-face physical therapy approach in this population. Specific Aim 1: To assess feasibility of the Rural Access to Physical Therapy for Osteoarthritis Rehabilitation (RAPTOR) program in delivering a hybrid telerehabilitation program to rural people with KOA. Hypothesis 1: Participants in the RAPTOR program will attend at least 80% of study-related in-person and telerehabilitation visits, and will experience no serious adverse events. Specific Aim 2: To determine preliminary clinical effectiveness of the RAPTOR program by assessing pain, physical function, and health-related quality of life via patient-reported and performance-based outcomes. Hypothesis 2: A majority of RAPTOR participants will demonstrate clinically meaningful improvement in patient-reported pain, physical function, and/or health-related quality of life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | RAPTOR protocol: hybrid in-person + telehealth physical therapy services | All participants will receive the RAPTOR intervention, which includes 2 in-person physical therapy visits and 8 telerehabilitation visits. Participants will attend an initial in-person PT evaluation to meet their provider, receive a hands-on assessment of their impairments and functional limitations, and receive instruction in an initial home exercise program. The remainder of their visits will be completed remotely, using a telerehabilitation platform. At the conclusion of care, the patient will return to the clinic for a follow-up assessment and training on their final home exercise program. |
Timeline
- Start date
- 2021-12-20
- Primary completion
- 2024-09-30
- Completion
- 2024-09-30
- First posted
- 2021-11-10
- Last updated
- 2024-10-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05114512. Inclusion in this directory is not an endorsement.