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Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
NYU Langone Health
New York, New York, United States
Start Date
September 1, 2021
Primary Completion Date
February 1, 2026
Completion Date
June 1, 2026
Last Updated
September 26, 2025
128
ESTIMATED participants
Physical Therapy with pressure cuff
BEHAVIORAL
Physical Therapy with placebo pressure cuff
BEHAVIORAL
Lead Sponsor
NYU Langone Health
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04535635