NCT03120052已完成不适用
Defining Components of Physical Therapy Achieving Maximum Function After Total Knee Replacement
University of Massachusetts, Worcester1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2018年1月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Differences in overall functional gain at 6 months
研究概览
简要总结
The overall goal of this study is to identify what Physical Therapy care components are associated with the best patient-reported functional outcome after Total Knee Replacement (TKR) surgery. The investigators are specifically looking at outcomes at 6 and 12 months after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are scheduled to undergo an elective, unilateral primary total knee replacement due to knee osteoarthritis
- •Will receive outpatient PT from a participating physical therapist.
- •Agree to record their exercise and activity for specific time points in the study.
排除标准
- •Total knee replacement scheduled for indications other than OA (e.g., fracture, malignancy, infection, or revision or prior implant)
- •The inability to obtain informed consent due to cognitive conditions.
- •Non-English speakers as the materials used in this project have not yet been tested with non-English speakers
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Differences in overall functional gain at 6 months
时间窗: 6 month follow-up
Differences in pre-operative to 6 month post -operative functional gain, using the SF-36 Physical Component Summary (PCS) Score by physical therapy regimen.
次要结局
- Differences in knee specific functional gain at 6 months(6 month follow-up)
- Differences in knee performance measures at 6 months(6 month follow-up)
研究者
Patricia Franklin
Principal Investigator
University of Massachusetts, Worcester
研究点 (1)
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