Rural Access to Physical Therapy for Osteoarthritis Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Recruitment Target
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
This is a single-group study; therefore, no masking is possible.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Recruitment Target
时间窗: 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.
Study-Related Adverse Events / Serious Adverse Events
时间窗: 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
时间窗: 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.
Telehealth Usability Questionnaire
时间窗: 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.
Visit Attendance (75% or higher)
时间窗: 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.
次要结局
- 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: 30-second chair stand test(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(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))
研究者
Allyn Bove
Assistant Professor
University of Pittsburgh