Blood flow restriction versus standard physical therapy after ankle ligament reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Center for Orthopedic Surgery
  Lubbock, Texas, United States Recruiting
• Texas Tech University Health Sciences Center
  Lubbock, Texas, United States Recruiting
• 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

Study contacts

• Principal investigator: Jerry Grimes, MD — Texas Tech University Health Sciences Center
• Study coordinator: Jenny Hudnall, MS BME
• Email: jennifer.hudnall@ttuhsc.edu
• Phone: 806-743-2260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.