Rural Access to Physical Therapy for Osteoarthritis Rehabilitation - Pilot

NCT05114512 | Completed

• 1 other identifier: STUDY21050074
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

arthritis; physical therapy; rehabilitation; rural; telehealth; telerehabilitation; knee; osteoarthritis

Outcome Measures

Primary Outcomes (5)

• Recruitment Target

  The investigators' recruitment target is 27 participants, and this outcome will be successful upon enrollment of the 27th participant. This outcome will be used as one component of the overall summary outcome of "feasibility", which is defined as success in all 5 primary outcomes.

  Through study completion, which is anticipated to take approximately 1 year.

• Visit Attendance (75% or higher)

  The percentage of physical therapy visits attended, divided by the number of scheduled visits (10) for each participant. This outcome will be successful if mean visit attendance among all participants is at least 75%. This outcome will be used as one component of the overall summary outcome of "feasibility", which is defined as success in all 5 primary outcomes.

  Through study completion, which is anticipated to take approximately 1 year.

• Telehealth Usability Questionnaire

  The Telehealth Usability Questionnaire (5/7) is a self-reported questionnaire used to assess participant satisfaction with the telehealth services received. It contains 21 items, each rated on a 7-point scale ranging from "strongly disagree" (1 point) to "strongly agree" (7 points). The items are summed to create a total score ranging from 7 - 147 points, with higher numbers indicating greater usability of the telehealth services. This outcome will be successful if the average item rating across all participants is at least 5/7. This outcome will be used as one component of the overall summary outcome of "feasibility", which is defined as success in all 5 primary outcomes.

  Measured at post-treatment (last visit, approximately 10 weeks after enrollment)

• Study-Related Adverse Events / Serious Adverse Events

  This outcome will be successful if there are zero study-related adverse events and serious adverse events among the 27 participants. This outcome will be used as one component of the overall summary outcome of "feasibility", which is defined as success in all 5 primary outcomes.

  Through study completion, which is anticipated to take approximately 1 year.

• Clinically Important Improvement on ONE Functional Outcome Measure

  The final component of the overall primary outcome of feasibility will be met if each participant achieves mean improvement on at least one functional outcome measure that exceeds the minimum clinically important difference. This may occur on a self-reported outcome measure (the KOOS, described below) or a performance-based outcome measure (30-second chair stand test, timed stair climb test, Timed Up and Go test, 40-meter fast-paced walk test, 6-minute walk test). All of these outcome measures are individually considered to be Secondary Outcome Measures and are described below in greater detail.

  Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)

Secondary Outcomes (6)

• Functional outcome measure: 30-second chair stand test

  Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)

• Functional outcome measure: Timed stair climb test

  Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)

• Functional outcome measure: Timed Up and Go (TUG)

  Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)

• Functional outcome measure: 40-meter fast-paced walk test

  Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)

• Functional outcome measure: 6-minute walk

  Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)

Study Arms (1)

RAPTOR Physical Therapy Intervention

EXPERIMENTAL

RAPTOR intervention: hybrid in-person + telehealth physical therapy care for rural-dwelling individuals with knee osteoarthritis

Other: RAPTOR protocol: hybrid in-person + telehealth physical therapy services

Interventions

RAPTOR protocol: hybrid in-person + telehealth physical therapy services OTHER

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.

RAPTOR Physical Therapy Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Pittsburgh Medical Center Rehabilitation Institute: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Allyn Bove, DPT, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single-group study; therefore, no masking is possible.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single cohort of 27 individuals

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: November 10, 2021
• Study Start: December 20, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available upon the conclusion of the study for up to seven years upon request.
• Access Criteria: Requests for data sharing must be agreed to by the investigators and the relevant institutional review board.

Locations

US (1)