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

Who can join

Ages 18 to 65 · All sexes

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.)

About the study

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).

What is being tested

• blood flow restriction (device)

Sponsor: Texas Tech University Health Sciences Center · Participants: 105 · Started: Mar 1, 2026

Contact the study team

• Jenny Hudnall, MS BME · Phone: 806-743-2260
• Evan Hernandez, MBA · Phone: 806-743-4600

Official record on ClinicalTrials.gov — NCT07451210

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.