NYU Langone Health
New York, 10016, United States
Location status: Recruiting
Location contact
Dhruv Shankar
CONTACT
Guillem Gonzalez-Lomas, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04149977
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
New York, 10016, United States
Location status: Recruiting
Dhruv Shankar
CONTACT
Guillem Gonzalez-Lomas, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Visit 1 Day 0
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Time frame: Visit 3 week 6
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Time frame: Visit 1 Day 0
Having bilateral thigh circumference measured
Time frame: Visit 1 Week 6
Having bilateral thigh circumference measured
Time frame: Visit 1 Day 0
The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function.
Time frame: Visit 3 week 6
The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function.
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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