Rehabilitation After Lower Extremity Nailing Trial (ReLENT)
The goal of this clinical trial is to learn if outpatient physical therapy (PT) results in differing functional outcomes compared to a self-guided home exercise program (HEP) in tibial or femoral nail patients. The hypothesis is that outpatient PT does not result in superior functional outcomes when compared to a self-guided home exercise program. Outpatient physical therapy for mobility and gait training is the current standard of care following lower extremity fractures.
To test this question, patients will be randomized into either PT or HEP group with PT serving as the control. Researchers will compare the PT and HEP groups to see if patient outcomes differ.
People who agree to join the study will be asked to attend 5 visits over one year. During these visits, they will receive surveys and physical assessments. They will also be asked to answer survey questions about their pain, recovery, and therapy through an email survey. The emailed surveys will be weekly for the first 3 months, then every 2 weeks until 6 months, then every 4 weeks until one year. There are 24 emailed surveys total.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Age 18 or older
- Unstable femoral or tibial shaft fracture treated with a locked intramedullary nail
- Willing and able to provide informed consent
Exclusion Criteria:
- Patients with weight-bearing or range of motion restrictions
- Patients treated surgically more than 3 weeks prior
- Previously non-ambulatory patients
- Pre-existing functional deficit of the lower extremities
- Patients over the age of 60 years
- Non-English-speaking patients
- Patients unwilling or unlikely to attend follow-up visits
Patients who sustain:
- Polytraumatic injuries that preclude the use of assistive devices
- Closed head injury limiting cognition
- Nerve injury resulting in motor deficits
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Formal Physical Therapy (PT)
Patients will be provided with a standardized prescription for outpatient PT.
The details of the prescription have been developed with the University of Chicago Medicine Physical Therapy Department.
Treatment will be prescribed for 2 sessions per week for a period of 6 weeks.
|
Formal Physical Therapy (PT)
|
|
有源比较器：Home Exercise Program (HEP)
Home exercise program (HEP) instructions will be provided to the HEP cohort and will include standardized exercises divided into three phases.
Progress through phases is based on functional criteria and is self-determined.
|
Home Exercise Program (HEP)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in SFMA (Selective Functional Movement Assessment) at 90 days
大体时间：Baseline, 90 days
|
The Selective Functional Movement Assessment (SFMA) is a functional movement assessment method to observe movement restrictions in individuals.
|
Baseline, 90 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Any difference in hip, knee, and ankle ROM (range of motion) measured with goniometer
大体时间：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measured in degrees
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in thigh circumference
大体时间：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measured in cm.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in gait speed
大体时间：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measured by timing how long it takes to walk a set distance and dividing the distance by the time.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in 30-second chair stand
大体时间：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Count the number of times the patient comes to a full standing position in 30 seconds from a chair.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in stair climb power test
大体时间：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
Measure of ability to ascend and descend a flight of stairs.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Any difference in VAS Pain Scale
大体时间：Participants will complete the following surveys in-person at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
The Visual Analogue Scale (VAS) for pain is a 100 mm line labeled "no pain" at 0 mm and "worst imaginable pain" at 100 mm
|
Participants will complete the following surveys in-person at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in OSPRO-YF (Optimal Screening for Prediction of Referral and Outcome-Yellow Flag)
大体时间：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
The OSPRO-YF is designed to help healthcare practitioners identify pain-related psychological characteristics in outpatient orthopedic settings.
As OSPRO-YF summarizes 11 psychological questionnaires, it is not scored like a conventional screening tool.
Quartile scores are used instead of cutoff scores for consistency and assessment of a wide range of outpatient orthopedic patients.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
|
Any difference in PROMIS Physical Function 8b short form
大体时间：Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
The PROMIS Physical Function form is a self-reported questionnaire assessing an individual's capability to perform daily physical activities.
|
Measured at 2-weeks, 6-weeks, 3-months, 6-months, and 1 year
|
合作者和调查者
调查人员
- 首席研究员：Mary K Erdman, M.D.、The University of Chicago Medical Center
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB25-0850
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.