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

RecruitingNAAges 18 Years - 65 YearsAllTexas Tech University Health Sciences Center
NCT07451210 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-65 years. 2. Post ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope). 3. Capability of paying for physical therapy or having insurance coverage for at least 6 weeks of therapy. Exclusion Criteria: 1. Major cardiac or connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome). 2. Autoimmune disorders. 3. History of stroke or deep vein thrombosis (DVT). 4. Bleeding or coagulation disorders. 5. Congenital or developmental musculoskeletal disorders (e.g., cerebral palsy, Parkinson's disease). 6. Pregnancy (current or planning to become pregnant in the next 4 months) 7. Malignancy (cancer). 8. Professional athletes. 9. Workers compensation insurance status as worker's compensation often does not cover the necessary duration of physical therapy (minimum of 4 weeks). 10. Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or 11. Be deemed unsuitable for inclusion in the study at the discretion of the Investigators 12. Cognitively not able to consent or participate in research (dementia; severe developmental delay; language/communication limitations; brain injury; etc.)
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What it tests

  • blood flow restriction
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Where

5 sites
Physical Therapy Today (PTT)
Lubbock, United States
University Medical Center
Lubbock, United States
Northstar Surgery Center
Lubbock, United States
The Center for Orthopedic Surgery
Lubbock, United States
Texas Tech University Health Sciences Center
Lubbock, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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