Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quadriceps Strength
研究概览
简要总结
Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participant and investigator will be aware of treatment arm allocation. Outcomes will be assessed in a masked fashion
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ACL tear undergoing reconstruction
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Blood flood restriction cuff (Device)
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.
结局指标
主要结局
Quadriceps Strength
时间窗: Three months
Quadriceps strength via handheld dynamometer
次要结局
- Knee range of motion(six months)
- Patient reported outcome measurement information system(Three months)
- Patient reported outcomes measurement information system(Six months)
- Pain scores(six months)
- Quadriceps Strength(six months)
- international knee documentation committee questionnaire(six months)
- Knee range of motion(three months)
- international knee documentation committee questionnaire(three months)
- Pain scores(three months)
研究者
Joseph Tramer
Resident Investigator
Henry Ford Health System