Blood flow restriction versus standard physical therapy after ankle ligament reconstruction

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

This project will test whether adding blood flow restriction (BFR) to regular physical therapy helps adults recovering from ankle ligament reconstruction regain muscle and function faster.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Texas Tech University Health Sciences Center (Academic / other)
• Locations: 5 sites (Lubbock, Texas and 4 other locations)
• Trial ID: NCT07451210 on ClinicalTrials.gov

What this trial studies

This randomized, single-blinded trial compares standard physical therapy (SoC) to physical therapy with blood flow restriction (BFR) for patients after ankle ligament reconstruction. Participants receive a minimum of six weeks of supervised physical therapy delivered by certified therapists, with outcome measures taken at the start and at the end of the therapy period. Key outcomes include muscle atrophy (circumference), strength and fatigability via manual muscle testing, ankle function using the FADI, pain using a visual analog scale, and resting cardiovascular measures. The study is conducted at participating sites in Lubbock, Texas.

Who should consider this trial

Good fit: Adults aged 18–65 who have had ankle ligament reconstruction and can attend and pay for or have insurance coverage for at least six weeks of physical therapy, and who do not have major cardiac, clotting, autoimmune, neurologic, pregnancy, cancer, or worker's compensation exclusions.

Not a fit: Patients with major cardiac or connective tissue disorders, clotting problems or recent DVT/stroke, autoimmune disease, pregnancy, active cancer, professional athletes, or those on worker's compensation are excluded and unlikely to derive benefit from participation.

Why it matters

Potential benefit: If successful, adding BFR could speed muscle recovery, reduce pain, and improve ankle function after reconstruction.

How similar studies have performed: Smaller orthopedic rehabilitation studies of BFR have shown promising gains in muscle size and strength, but high-quality evidence specifically after ankle ligament reconstruction is limited.

Eligibility criteria

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.)

Where this trial is running

Lubbock, Texas and 4 other locations

• Physical Therapy Today (PTT) — Lubbock, Texas, United States (Active_not_recruiting)
• University Medical Center — Lubbock, Texas, United States (Active_not_recruiting)
• Northstar Surgery Center — Lubbock, Texas, United States (Active_not_recruiting)
• The Center for Orthopedic Surgery — Lubbock, Texas, United States (Recruiting)
• Texas Tech University Health Sciences Center — Lubbock, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Jerry Grimes, MD — Texas Tech University Health Sciences Center
• Study coordinator: Jenny Hudnall, MS BME

Conditions Ankle Reconstruction; Blood Flow Restriction Therapy; Physical Therapy; ankle reconstruction; physical therapy; blood flow restriction therapy; BFR