A Pilot Study to Test the Feasibility of a Hybrid Preoperative Physical Therapy Intervention for Patients Undergoing Total Joint Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b
研究概览
简要总结
This study aims to determine the feasibility of implementing a hybrid physical therapy intervention prior to total joint replacement surgery.
详细描述
Study objectives include: 1) testing the feasibility of a hybrid preoperative physical therapy intervention for physically deconditioned patients undergoing total hip and knee replacement, and 2) observing differences in post-surgical outcomes such as pain, pain interference, function and healthcare utilization, between patients who receive the intervention and those who do not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is above 55 years old, indicated for primary total knee or hip replacement surgery and is deconditioned based on the surgeon's clinical judgement (i.e., Use of walker, limited or staggered gait, difficulty in sit to stand) as recorded in study log.
- •Patient falls below the median score on the HOOS/KOOS JR/PROMIS physical function (<47.4, <49.8, ≤ 37 respectively and below the median score on the PROMIS Pain Interference score (≥63).
- •Patient has access to technology to participate in telehealth.
排除标准
- •Patient is not ambulatory
- •Patient is scheduled for bilateral arthroplasty or revision arthroplasty.
- •Patient is morbidly obese (BMI >40).
- •Patient has pre-existing medical condition that is contraindicated for exercise such as unstable cardiomyopathy
结局指标
主要结局
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b
时间窗: Month 2, Month 5
PROMIS - Pain Interference - Short Form 6b measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional physical, and recreational activities. Pain Interference items utilize a 7-day recall period ("the past 7 days"). PROMIS - PI - Short Form 6b consists of 6 items. Each question is scored between 1 to 5. The total score range is 6-30; the higher the score the more of the concept is being measured (more pain interference).
次要结局
- Average Number of Physical Therapy Sessions Since Enrollment in the Study(Month 2)
- Number of Readmissions(Month 5)
- Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a(Month 2, Month 5)
- Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)(Month 2, Month 5)
- Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)(Month 2, Month 5)
- Average Number of Times Per Week Participants Had Physical Therapy(Month 2)
- Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)(Month 2, Month 5)