Actively Recruiting
Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study
Led by NYU Langone Health · Updated on 2025-09-26
128
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating blood flow restriction therapy for patients with lower limb extensor injuries such as quadriceps tendon rupture, patella tendon rupture, and patella fracture. This therapy aims to promote muscle growth and strength by restricting venous outflow using an inflatable cuff, creating a high-intensity environment that may improve rehabilitation. The study is randomized and double-blind to compare this therapy against a placebo treatment. Participants will receive six weeks of physical therapy exercises similar to standard care, but with a pressure cuff placed around the upper thigh of the injured leg. In the experimental group, the cuff pressure will restrict approximately 80% of arterial blood flow, adjusted by a device that monitors and controls pressure. The placebo group will have a cuff with pressure set at 50% less than the effective level. The cuff includes safety features like automatic deflation timers and alarms for under or over pressurization. During the study, participants will have their leg extensor strength and knee function measured at the start and after six weeks. Researchers will track changes in muscle strength and recovery using these assessments. The trial lasts for six weeks of treatment with ongoing monitoring for safety and effectiveness. Participants must be between 18 and 65 years old and intend to receive physical therapy as part of their standard care.
CONDITIONS
Brief Title
Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be at least 18 years of age and younger than 65 years of age
- ASA class I-II
- Diagnosed with a lower limb extensor injury such as quadriceps tendon rupture, patella tendon rupture, or patella fracture
- Intention to receive physical therapy as standard of care
You will not qualify if you...
- Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
- Younger than 18 years of age or older than 65
- Any patient considered a vulnerable subject
- Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension
- Concomitant lower extremity traumatic injuries that delay or prevent participation in therapy
- Immobile or use of mobile assistive device prior to injury
- No prior extensor injuries
- Patients with Sickle cell anemia or venous thromboembolism
- Patients with cancer or lymphectomies
- Patients with increased intracranial pressure
- Patients with intention to receive standard therapy and not the study therapy
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.
1 visit (in-person)
Duration - 6 weeks
Participants receive physical therapy with a pressure cuff placed around the affected leg during exercises for 6 weeks to promote muscle hypertrophy and rehabilitation.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
S
Samy Shelbaya
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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