ACL 撕裂后使用血流限制疗法
血流限制 (BFR) 疗法在前交叉韧带撕裂后围手术期康复中的应用
Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear
研究概览
详细说明
The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity.
The goal of this investigation is to determine if using BFR during perioperative therapy would lead to increased and expedited strength gains. Additionally we would like to determine if BFR helps patients to pass the standard rehabilitative functional tests and return to play sooner. We will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding ACL tear and reconstruction.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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West Bloomfield、Michigan、美国、48332
- Henry Ford Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ACL tear undergoing reconstruction
Exclusion Criteria:
- History of pulmonary embolism
- History of deep vein thrombosis
- Family history of PE/DVT
- Hypercoaguable disorder
- Multiligamentous knee injury
- Neurovascular injury
- Peripheral vascular disease
- Unable to complete physical therapy
- Unable to tolerate blood flow restriction
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：BFR Treatment
Patients will be recruited following ACL tear and medical screening for history of DVT/PE. Patients allocated to the BFR intervention group will undergo physical therapy with the use of a blood flow restriction cuff. Rehabilitation will consist of a structured home exercise program prior to surgery. We will instruct patients on how to perform home BFR and test them in the office to ensure competence. Following surgery patients will immediately be started in physical therapy. Therapy will consist of a structured program progressing from range of motion, to strength training and then functional tests. Both arms will use the same protocol with the only difference being use of BFR. |
Blood flow restriction cuffs will be used as an augment to physical therapy |
|
无干预：Control
The control arm will undergo the same pre and post operative physical therapy as the BFR group. They will undergo a structure home therapy program prior to surgery and an outpatient physical therapy program under the guidance of a therapist following surgery. |
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 |
|---|---|---|
|
Quadriceps Strength in the Operative Leg
大体时间：Change from Initial Clinic Visit to Pre-op
|
Quadriceps strength via handheld dynamometer. Quadriceps torque generation of operative leg evaluated at Initial Clinic Visit (ICV) and Pre-op (surgery scheduled 2 weeks after ICV) |
Change from Initial Clinic Visit to Pre-op
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Reported Outcome Measurement Information System
大体时间：Initial Clinic Visit
|
Patient reported outcomes measurement information system score on patient physical function. PROMIS-PF: Assesses Activities of Daily Living and Capabilities. Below 30: Severe limitations, 30-40: Moderate limitations, 40-45: Mild limitations, Above 50: Greater than average physical function. Score scale (0-100) PROMIS-PI: Assesses Pain Indication. Below 55: Within normal limits of pain interference, 50-59: Mild interference, 60-69: Moderate interference, Above 70: Severe pain interference. Score scale (0-100) PROMIS-D: Measures Depressive symptoms: Below 55: Normal to slight symptoms, 55-59: Mild symptoms, 60-69: Moderate symptoms, Above 70: Severe depressive symptoms. Score scale (0-100) |
Initial Clinic Visit
|
|
Participants Reporting Pain Using the Visual Analog Scale
大体时间：Three months
|
Visual analog scale pain scores, scale 0-10 higher is more pain |
Three months
|
|
Quadricep Strength in Non-operated Leg
大体时间：Change from Initial Clinic Visit to Pre-Op
|
Quadriceps torque generation of non-operative leg evaluated at Initial Clinic Visit (ICV) and Pre-op (surgery scheduled 2 weeks after ICV) |
Change from Initial Clinic Visit to Pre-Op
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
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