Osteoarthritis, KneeRAPTORNCT05114512
Rural Access to Physical Therapy for Osteoarthritis Rehabilitation - Pilot
A study testing RAPTOR protocol: hybrid in-person + telehealth physical therapy services in people with Osteoarthritis, Knee, run by University of Pittsburgh at 1 site in United States.
Trial 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'… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- RAPTOR protocol: hybrid in-person + telehealth physical therapy services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: 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.
Read the 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
- Osteoarthritis, Knee
- Being tested
- RAPTOR protocol: hybrid in-person + telehealth physical therapy services
- Keywords
- arthritis, physical therapy, rehabilitation, rural, telehealth, telerehabilitation, knee, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAPTOR protocol: hybrid in-person + telehealth physical therapy servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RAPTOR Physical Therapy Intervention | Experimental | RAPTOR intervention: hybrid in-person + telehealth physical therapy care for rural-dwelling individuals with knee osteoarthritis Receives: Other: RAPTOR protocol: hybrid in-person + telehealth physical therapy services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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: 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.
Measured: 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.
Measured: 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
Measures the number of times the participant can stand up and sit down from a chair in a 30-second period.
Measured: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Functional outcome measure: Timed stair climb test
Measures the number of seconds it takes the participant to climb and descend 1 full flight of standard stairs.
Measured: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Functional outcome measure: Timed Up and Go (TUG)
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.
Measured: 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
Measures the number of seconds it takes the participant to walk 40 meters at what the participant considers to be a "fast pace".
Measured: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Functional outcome measure: 6-minute walk
Measures the number of meters the participant can walk in 6 minutes at a self-selected pace.
Measured: 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
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.
Measured: Baseline (measured at first visit) and post-treatment (measured at last visit, approximately 10 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start20 Dec 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single cohort of 27 individuals
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center Rehabilitation Institute
- Responsible party
- Principal investigator, Allyn Bove, University of Pittsburgh
- Investigators
- Allyn Bove, DPT, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114512
- Sponsor's protocol ID
- STUDY21050074
- Acronym
- RAPTOR
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2021
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only fully deidentified data will be made available to other researchers upon request and approval by the investigators and the relevant institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Access to Physical Therapy for Osteoarthritis Rehabilitation
- ClinicalTrials.gov ID
- NCT05114512
- Acronym / sponsor ID
- RAPTOR / STUDY21050074
- Conditions
- Osteoarthritis, Knee
- Keywords
- arthritis, physical therapy, rehabilitation, rural, telehealth, telerehabilitation, knee, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center Rehabilitation Institute
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single cohort of 27 individuals
| Arm | Type | Receives |
|---|---|---|
| RAPTOR Physical Therapy Intervention | Experimental | Other: RAPTOR protocol: hybrid in-person + telehealth physical therapy servicesRAPTOR intervention: hybrid in-person + telehealth physical therapy care for rural-dwelling individuals with knee osteoarthritis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAPTOR protocol: hybrid in-person + telehealth physical therapy servicesAll 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. | Other | RAPTOR Physical Therapy Intervention |
Primary outcome
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.
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.
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.
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.
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.
6 secondary outcomes
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)
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)
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)
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)
Functional outcome measure: 6-minute walk
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: Yes. Only fully deidentified data will be made available to other researchers upon request and approval by the investigators and the relevant institutional review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allyn Bove, DPT, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAPTOR protocol: hybrid in-person + telehealth physical therapy services in people with Osteoarthritis, Knee, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Target (time frame: Through study completion, which is anticipated to take approximately 1 year.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.