Use of Blood Flow Restriction Therapy Following ACL Tear
- Conditions
- Anterior Cruciate Ligament TearKnee InjuriesSport Injury
- Interventions
- Device: Blood flood restriction cuff
- Registration Number
- NCT04374968
- Lead Sponsor
- Henry Ford Health System
- Brief Summary
Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- ACL tear undergoing reconstruction
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BFR Treatment Blood flood restriction cuff 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.
- Primary Outcome Measures
Name Time Method Quadriceps Strength Three months Quadriceps strength via handheld dynamometer
- Secondary Outcome Measures
Name Time Method Knee range of motion six months Knee range of motion via goniometer
Patient reported outcome measurement information system Three months Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better
Patient reported outcomes measurement information system Six months Patient reported outcomes measurement information system score on patient physical function, scale 0-100 with higher scores better
Pain scores six months Visual analog scale pain scores, scale 0-10 higher is more pain
Quadriceps Strength six months Quadriceps strength via handheld dynamometer
international knee documentation committee questionnaire six months international knee documentation committee questionnaire, scale 0-100 with higher scores better
Trial Locations
- Locations (1)
Henry Ford Hospital
🇺🇸West Bloomfield, Michigan, United States