Trials / Withdrawn
WithdrawnNCT04528992
Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation
Effects of Blood Flow Restriction (BFR) Therapy on Early Anterior Cruciate Ligament (ACL) Graft Maturation
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.
Detailed description
The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol. To be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Blood Flow Restriction Therapy | BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery. |
| OTHER | Standard Postoperative Physical Therapy | This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction. |
Timeline
- Start date
- 2024-09-20
- Primary completion
- 2024-09-20
- Completion
- 2024-09-20
- First posted
- 2020-08-27
- Last updated
- 2024-11-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04528992. Inclusion in this directory is not an endorsement.