Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
Texas Tech University Health Sciences Center
105 participants
Mar 1, 2026
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
Inclusion Criteria3
- Age 18-65 years.
- Post ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope).
- Capability of paying for physical therapy or having insurance coverage for at least 6 weeks of therapy.
Exclusion Criteria12
- Major cardiac or connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome).
- Autoimmune disorders.
- History of stroke or deep vein thrombosis (DVT).
- Bleeding or coagulation disorders.
- Congenital or developmental musculoskeletal disorders (e.g., cerebral palsy, Parkinson's disease).
- Pregnancy (current or planning to become pregnant in the next 4 months)
- Malignancy (cancer).
- Professional athletes.
- Workers compensation insurance status as worker's compensation often does not cover the necessary duration of physical therapy (minimum of 4 weeks).
- Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
- Be deemed unsuitable for inclusion in the study at the discretion of the Investigators
- Cognitively not able to consent or participate in research (dementia; severe developmental delay; language/communication limitations; brain injury; etc.)
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07451210