Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Injury
• Intervention / Treatment: Behavioral: Physical Therapy with pressure cuff; Behavioral: Physical Therapy with placebo pressure cuff

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 Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samy Shelbaya; Phone Number: 517-575-5522; Email: samy.shelbaya@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Dhruv Shankar; Phone Number: 240-848-8645; Email: dhruv.shankar@nyulangone.org
      • Principal Investigator: Guillem Gonzalez-Lomas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in extensor strength of both legs	Isokinetic strength testing with a Biodex dynamometer to measure peak torque	Visit 1 Day 0
Change in extensor strength of both legs	Isokinetic strength testing with a Biodex dynamometer to measure peak torque	Visit 3 week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in recovery, muscle strength	Having bilateral thigh circumference measured	Visit 1 Day 0
Change in recovery, muscle strength	Having bilateral thigh circumference measured	Visit 1 Week 6
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.	Visit 1 Day 0
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.	Visit 3 week 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Guillem Gonzales-Lomas, MD, NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: 19-01269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No