Clinical Trial

Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction

Study acronym: BFRankle recon
Recruiting
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Summary
The goal of this single blinded clinical trial is to investigate blood flow restriction (BFR) for rehabilitation of patients after ankle ligament reconstruction surgery. Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention. Following standard surgical procedures, both groups will undergo physical therapy by a certified physical therapist for a minimum of 6 weeks. The SOC group will receive standard physical therapy without use of BFR. The BFR group will receive physical therapy with BFR. Outcome measures of interest will be taken at the start of physical therapy (time 0) and at the end of physical therapy (minimum of 6 weeks of PT) for both groups. Outcome measures of interest include: * muscle atrophy; * ankle function; * fatigability/manual muscle testing; * pain scores; * cardiovascular effects (heart rate, blood pressure).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-27.
Status change: Not Yet Recruiting → Recruiting 2026-03-13
Trial Details
NCT Number NCT07451210
Lead Sponsor Texas Tech University Health Sciences Center
Collaborators: The Center for Orthopedic Surgery, UMC Health System, H2 Health (Physical Therapy Today), Northstar Surgery Center
Conditions Ankle Reconstruction, Blood Flow Restriction Therapy, Physical Therapy
Enrollment 105 participants
Start Date 2026-03-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-17