NCT04149977

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.

Detailed description

The purpose is to restrict venous outflow with an inflatable cuff to create a high intensity environment increases muscle hypertrophy, thus promoting a more efficient form of rehabilitation. Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff. The cuff is placed around the desired limb before a specific exercise, the physical therapist determines the appropriate pressure and time, and the patient completes the exercise as they normally would. The monitor determines the limb occlusion pressure and has an automatic timer that will deflate after the specified time has elapsed. There are also audio and visual alarms that alert the user of under or over pressurization. The specific pressure will vary based on patient's tolerance and will stay consistent through each exercise. Thus far blood flow restriction therapy has been tested in patients with several pathologies but there is limited literature on its effect on lower limb extensor injuries.

Conditions

• Lower Limb Injury

Interventions

Type	Name	Description
BEHAVIORAL	Physical Therapy with pressure cuff	6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a cuff around the affected leg during the exercises.
BEHAVIORAL	Physical Therapy with placebo pressure cuff	6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a pressure cuff around the affected leg during the exercises. The pressure cuff will have 50% of the pressure that will be considered effective.

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2019-11-04
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States