Actively Recruiting
Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
Led by Texas Tech University Health Sciences Center · Updated on 2026-03-17
105
Participants Needed
5
Research Sites
95 weeks
Total Duration
On this page
Sponsors
T
Texas Tech University Health Sciences Center
Lead Sponsor
T
The Center for Orthopedic Surgery
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years
- Have undergone ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope)
- Able to pay for physical therapy or have insurance coverage for at least 6 weeks of therapy
You will not qualify if you...
- Major cardiac or connective tissue disorders such as Ehlers-Danlos syndrome or Marfan syndrome
- Autoimmune disorders
- History of stroke or deep vein thrombosis (DVT)
- Bleeding or coagulation disorders
- Congenital or developmental musculoskeletal disorders like cerebral palsy or Parkinson's disease
- Current pregnancy or planning pregnancy within 4 months
- Malignancy (cancer)
- Professional athletes
- Workers compensation insurance status due to therapy coverage limitations
- Enrolled in another interventional clinical study within past 30 days
- Deemed unsuitable for study participation by investigators
- Unable to consent or participate due to cognitive or communication impairments
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Physical Therapy Today (PTT)
Lubbock, Texas, United States, 79407
Active, Not Recruiting
2
University Medical Center
Lubbock, Texas, United States, 79415
Active, Not Recruiting
3
Northstar Surgery Center
Lubbock, Texas, United States, 79416
Active, Not Recruiting
4
The Center for Orthopedic Surgery
Lubbock, Texas, United States, 79416
Actively Recruiting
5
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Actively Recruiting
Research Team
J
Jenny Hudnall, MS BME
CONTACT
E
Evan Hernandez, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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