Rural Access to Physical Therapy for Osteoarthritis Rehabilitation - Pilot (RAPTOR)

October 2, 2024 updated by: Allyn Bove, University of Pittsburgh

Rural Access to Physical Therapy for Osteoarthritis Rehabilitation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Alexa Vareldzis, BS, SPT
  • Phone Number: 4126249255
  • Email: alv66@pitt.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RAPTOR Physical Therapy Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Target
Time Frame: Through study completion, which is anticipated to take approximately 1 year.
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)
Time Frame: Through study completion, which is anticipated to take approximately 1 year.
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
Time Frame: Measured at post-treatment (last visit, approximately 10 weeks after enrollment)
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
Time Frame: Through study completion, which is anticipated to take approximately 1 year.
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
Time Frame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional outcome measure: 30-second chair stand test
Time Frame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Measures the number of times the participant can stand up and sit down from a chair in a 30-second period.
Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Functional outcome measure: Timed stair climb test
Time Frame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Measures the number of seconds it takes the participant to climb and descend 1 full flight of standard stairs.
Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Functional outcome measure: Timed Up and Go (TUG)
Time Frame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Measures the number of seconds it takes for the participant to stand up from a chair, walk 3 meters, turn around, walk 3 meters back to the chair, and sit back down in the chair.
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
Time Frame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Measures the number of seconds it takes the participant to walk 40 meters at what the participant considers to be a "fast pace".
Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Functional outcome measure: 6-minute walk
Time Frame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Measures the number of meters the participant can walk in 6 minutes at a self-selected pace.
Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Functional outcome measure: Change from baseline in KOOS (Knee Injury and Osteoarthritis Outcome Score) to Post-Treatment
Time Frame: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
The KOOS is a self-reported survey containing five subscales, each of which is considered separately (i.e. there is no "total" KOOS score). The investigators will use three of the KOOS subscales: Pain (Minimum Detectable Change [MDC] 13.4 points for people with KOA), Activities of Daily Living (MDC 15.4 points), and Quality of Life (MDC 21.1 points). Each subscale is measured on a 0-100 scale, with lower scores indicating worse symptoms / worse function.
Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh Medical Center Rehabilitation Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Allyn Bove, DPT, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY21050074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only fully deidentified data will be made available to other researchers upon request and approval by the investigators and the relevant institutional review board.

IPD Sharing Time Frame

Data will be made available upon the conclusion of the study for up to seven years upon request.

IPD Sharing Access Criteria

Requests for data sharing must be agreed to by the investigators and the relevant institutional review board.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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