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Evaluating Blood Flow Restriction Therapy for Lower Limb Extensor Injuries A Randomized Double-Blind Study Comparing Therapy Effectiveness
Led by NYU Langone Health · Updated on 2025-09-26
128
Participants Needed
1
Research Sites
17 weeks
Total Duration
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
Research Team
S
Samy Shelbaya
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