Clinical trial NCT05114512: Rural Access to Physical Therapy for Osteoarthritis Rehabilitation - Pilot
Official title: Rural Access to Physical Therapy for Osteoarthritis Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: arthritis
physical therapy
rehabilitation
rural
telehealth
telerehabilitation
knee
osteoarthritis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center Rehabilitation Institute
First posted: 2021-11-10
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single cohort of 27 individuals
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Potential participants who meet all of the following criteria will be included:

* Participant meets American College of Rheumatology criteria for the clinical diagnosis of knee osteoarthritis
* Participant's home address is in a rural (non-core) western Pennsylvania county
* Participant is willing to travel to Centers for Rehab Services - Bedford clinic for two face-to-face sessions with a licensed physical therapist
* Participant has access to high-speed internet and/or LTE wireless service and a device (tablet, computer, or smartphone) to access the telerehabilitation platform
* Participant is aged 40 or over

Potential participants will be excluded if any of the following criteria apply:

* Chronic neurological disorder affecting balance or coordination
* Any other disorder that affects balance or gait
* Two or more falls in the past 12 months, OR sought medical attention for any fall within the past 12 months

Primary outcomes:
measure: Recruitment Target
timeFrame: Through study completion, which is anticipated to take approximately 1 year.
measure: Visit Attendance (75% or higher)
timeFrame: Through study completion, which is anticipated to take approximately 1 year.
measure: Telehealth Usability Questionnaire
timeFrame: Measured at post-treatment (last visit, approximately 10 weeks after enrollment)
measure: Study-Related Adverse Events / Serious Adverse Events
timeFrame: Through study completion, which is anticipated to take approximately 1 year.
measure: Clinically Important Improvement on ONE Functional Outcome Measure
timeFrame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Secondary outcomes:
measure: Functional outcome measure: 30-second chair stand test
timeFrame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
measure: Functional outcome measure: Timed stair climb test
timeFrame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
measure: Functional outcome measure: Timed Up and Go (TUG)
timeFrame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
measure: Functional outcome measure: 40-meter fast-paced walk test
timeFrame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
measure: Functional outcome measure: 6-minute walk
timeFrame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
measure: Functional outcome measure: Change from baseline in KOOS (Knee Injury and Osteoarthritis Outcome Score) to Post-Treatment
timeFrame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Allyn Bove, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: