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Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

Primary Purpose

Lower Limb Injury

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical Therapy with pressure cuff

Physical Therapy with placebo pressure cuff

About this trial

This is an interventional treatment trial for Lower Limb Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

blood flow restriction therapy (pressure cuff)

blood flow restriction therapy (placebo)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in extensor strength of both legs

Isokinetic strength testing with a Biodex dynamometer to measure peak torque

Change in extensor strength of both legs

Isokinetic strength testing with a Biodex dynamometer to measure peak torque

Secondary Outcome Measures

Change in recovery, muscle strength

Having bilateral thigh circumference measured

Change in recovery, muscle strength

Having bilateral thigh circumference measured

Change in Knee function

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

Full Information

NCT ID

NCT04149977

First Posted

October 31, 2019

Last Updated

September 6, 2023

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT04149977

Brief Title

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lower Limb Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Masking Description

double blind

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

blood flow restriction therapy (pressure cuff)

Arm Type

Experimental

Arm Description

Arm Title

blood flow restriction therapy (placebo)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Physical Therapy with pressure cuff

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Physical Therapy with placebo pressure cuff

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in extensor strength of both legs

Description

Isokinetic strength testing with a Biodex dynamometer to measure peak torque

Time Frame

Visit 1 Day 0

Title

Change in extensor strength of both legs

Description

Isokinetic strength testing with a Biodex dynamometer to measure peak torque

Time Frame

Visit 3 week 6

Secondary Outcome Measure Information:

Title

Change in recovery, muscle strength

Description

Having bilateral thigh circumference measured

Time Frame

Visit 1 Day 0

Title

Change in recovery, muscle strength

Description

Having bilateral thigh circumference measured

Time Frame

Visit 1 Week 6

Title

Change in Knee function

Description

Time Frame

Visit 1 Day 0

Title

Change in Knee function

Description

Time Frame

Visit 3 week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Moore

Phone

347-554-0183

Michael.Moore@nyulangone.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillem Gonzales-Lomas, MD

Organizational Affiliation

NYU Langone

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dhruv Shankar

Phone

240-848-8645

dhruv.shankar@nyulangone.org

First Name & Middle Initial & Last Name & Degree

Guillem Gonzalez-Lomas, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) may be available upon reasonable request. Requests should be directed to Jordan.Fried@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data.

Learn more about this trial

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

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