Blood Flow Restriction Following ACLR w/Quad Autograft
Part of paid clinical trials in Kansas City, Kansas.
- Sponsor
- University of Kansas Medical Center
- Study ID
- NCT06636045
- Status
- Enrolling By Invitation
Conditions
- Anterior Cruciate Ligament Reconstruction
- Autografts
- Blood Flow Restriction Therapy
- Quadriceps Muscle Strength
- Rehabilitation Outcome
Eligibility Criteria
- Sex
- ALL
- Age
- 14 Years - 40 Years
- Healthy Volunteers
- Not accepted
Interventions
- Not applicable- observational study — OTHERNo intervention. Observational study.
Study Details
This project is intended to acquire objective measurements of implementing BFR rehabilitation in ACL reconstructions to show any changes upon completion of the BFR protocol. The results in this study will hopefully represent valuable data in the support of using autografts for ACL reconstructions in high level athletes wanting a full recovery and return to high level of sport. It has been speculated that use of autografts in ACL reconstructions leads to more quad weakness and muscle atrophy due to tendon harvesting. (Slone et al., 2015) More recently, BFR has shown promise in expediting the recovery and rehabilitation process post-surgically. By implementing BFR following ACL reconstructions with autografts, we hope to mitigate the major deterrent for autograft use and giving patients a more cost-effective approach to surgery. (Hughes et al., 2019)
Key Dates
- Start date
- Sep 5, 2024
- Status verified
- Aug 2024
- Primary completion
- Oct 31, 2026
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 40 participants (estimated)
Arms
- Arm: BFR GroupBlood Flow Restriction (BFR) will be administered in conjunction with regular physical therapy exercises. BFR training will begin as early as 2 weeks post-op. For 2-3 times/week, as indicated by the patient's physical therapist. This is part of standard practice. Each session will consist of 4 sets (30, 15, 15, and 15 reps) at 80% limb occlusion pressure.
- Arm: Control GroupThis group will perform physical therapy without the use of BFR
Primary Outcome Measure
Quad muscle Strength [ Time Frame: At 6 week post surgical timepoints ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Kansas medical Center | Kansas City | Kansas | 66160 | - |
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