Actively Recruiting
Effect of Blood Flow Restriction (BFR) Rehabilitation After Achilles Tendon Rupture Reconstruction
Led by The Methodist Hospital Research Institute · Updated on 2025-05-06
19
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of blood flow restriction (BFR) therapy combined with standard physical therapy after Achilles tendon rupture reconstruction. The goal is to see if BFR can reduce muscle loss, improve ankle motion and strength, and shorten the time it takes for patients to return to play compared to standard rehab alone. Participants will be randomly assigned to one of two groups: one receiving standard rehab exercises modified by a tourniquet device for BFR therapy, and a control group receiving only the standard rehab protocol. Both groups will follow physical therapy twice a week from four weeks to sixteen weeks after surgery. Throughout the study, patients will have body composition scans and complete questionnaires before surgery and at several points up to sixteen weeks after surgery. Researchers will measure muscle mass, bone density, pain, physical activity, ankle range of motion, and heel raise strength to evaluate recovery. The study involves regular assessments during rehab to monitor progress and outcomes.
CONDITIONS
Brief Title
Effect of BFR Rehab After Achilles Tendon Rupture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Achilles rupture confirmed by MRI or Thompson Test
- Adult (18 years or older)
- Scheduled to receive Percutaneous Achilles Repair System (PARS) or open repair surgery
- Planned physical therapy at Methodist location
You will not qualify if you...
- Obesity with BMI greater than 35
- Diabetes
- Cardiovascular, renal, liver, or pulmonary disease
- Active infections
- Cancer current or treated within past 2 years, or coagulation disorder
- Physically unable to participate in intervention
- Unable to complete at least 85% of assigned rehabilitation sessions
- Under 18 years of age
- Pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 weeks post-op
Participants undergo Achilles tendon rupture reconstruction surgery followed by initial post-operative recovery.
Duration - 12 weeks
Starting 4 weeks post-op, participants receive physical therapy twice a week until week 16. The experimental group receives blood flow restriction therapy in addition to standard physical therapy, while the control group receives standard physical therapy alone.
Twice weekly visits for physical therapy from week 4 to week 16 post-op
Duration - Pre-op to 16 weeks post-op
Participants complete full body composition scans and questionnaires before surgery, and at 4, 8, and 16 weeks post-op to evaluate muscle mass, bone density, pain, physical activity, Achilles tendon function, range of motion, and strength.
4 visits (pre-op, 4 weeks, 8 weeks, and 16 weeks post-op)
Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Haley Goble
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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