Trials / Completed
CompletedNCT04374968
Use of Blood Flow Restriction Therapy Following ACL Tear
Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Anterior Cruciate Ligament Tear
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Henry Ford Health System · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Blood flood restriction cuff | Blood flow restriction cuffs will be used as an augment to physical therapy |
Timeline
- Start date
- 2020-07-28
- Primary completion
- 2022-05-01
- Completion
- 2022-05-01
- First posted
- 2020-05-05
- Last updated
- 2023-07-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04374968. Inclusion in this directory is not an endorsement.