RecruitingNot ApplicableNCT07451210

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


Sponsor

Texas Tech University Health Sciences Center

Enrollment

105 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called blood flow restriction for people with ankle reconstruction, blood flow restriction therapy, and other related conditions. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEblood flow restriction

The intervention group will receive the standard of care PT performed with BFR on affected limb. The intervention group will be treated with a BFR Smarttools SmartCuffs versions 3.0 or higher. During the baseline visit, the device will be placed over the affected limb's greater trochanter and inflated to 60% of their limb occlusion pressure. This will be titrated up to 80% over the first week to ensure subject comfort. During the remaining physical therapy sessions, patients will perform exercises prescribed by a licensed t-PT to perform under occlusion with a load of 30% of the subjects estimated 1-rep max.


Locations(5)

Physical Therapy Today (PTT)

Lubbock, Texas, United States

University Medical Center

Lubbock, Texas, United States

Northstar Surgery Center

Lubbock, Texas, United States

The Center for Orthopedic Surgery

Lubbock, Texas, United States

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

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NCT07451210


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