Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

Sponsor

NYU Langone Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT04149977

Collaborator

(none)

100

Enrollment

Location

Arms

23.9

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lower Limb Injury	Behavioral: Physical Therapy with pressure cuff Behavioral: Physical Therapy with placebo pressure cuff	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

double blind

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 5, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: blood flow restriction therapy (pressure cuff) The cuff will be placed around the upper thigh of the injured leg and set at a pressure that will prevent approximately 80% arterial blood flow. The machine will determine what pressure is required to reach that 80%, when placed on the leg and turned on.	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.
Placebo Comparator: blood flow restriction therapy (placebo) Patients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm	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.

Arm

Intervention/Treatment

Experimental: blood flow restriction therapy (pressure cuff)

The cuff will be placed around the upper thigh of the injured leg and set at a pressure that will prevent approximately 80% arterial blood flow. The machine will determine what pressure is required to reach that 80%, when placed on the leg and turned on.

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.

Placebo Comparator: blood flow restriction therapy (placebo)

Patients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm

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.

Outcome Measures

Primary Outcome Measures

Change in extensor strength of both legs [Visit 1 Day 0]
Isokinetic strength testing with a Biodex dynamometer to measure peak torque
Change in extensor strength of both legs [Visit 3 week 6]
Isokinetic strength testing with a Biodex dynamometer to measure peak torque

Secondary Outcome Measures

Change in recovery, muscle strength [Visit 1 Day 0]
Having bilateral thigh circumference measured
Change in recovery, muscle strength [Visit 1 Week 6]
Having bilateral thigh circumference measured
Change in Knee function [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.
Change in Knee function [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 (quadriceps tendon rupture, patella tendon rupture, patella fracture)
Intention to receive physical therapy as standard of care

Exclusion Criteria:

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, delaying or precluding the subject's ability to participate in the 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Guillem Gonzales-Lomas, MD, NYU Langone

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT04149977

Other Study ID Numbers:

19-01269

First Posted:

Nov 4, 2019

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wounds and Injuries

Leg Injuries

Study Results

No Results Posted as of Nov 19, 2021