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NCT Number: NCT04149977

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Dhruv Shankar

CONTACT

[email protected]

240-848-8645

Guillem Gonzalez-Lomas, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy with pressure cuff

Behavioral

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.

Physical Therapy with placebo pressure cuff

Behavioral

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 outcomes

  1. Change in extensor strength of both legs

    Time frame: Visit 1 Day 0

    Isokinetic strength testing with a Biodex dynamometer to measure peak torque

  2. Change in extensor strength of both legs

    Time frame: Visit 3 week 6

    Isokinetic strength testing with a Biodex dynamometer to measure peak torque

Secondary outcomes

  1. Change in recovery, muscle strength

    Time frame: Visit 1 Day 0

    Having bilateral thigh circumference measured

  2. Change in recovery, muscle strength

    Time frame: Visit 1 Week 6

    Having bilateral thigh circumference measured

  3. Change in Knee function

    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.

  4. Change in 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samy Shelbaya

CONTACT

[email protected]

517-575-5522

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2019
Registry last updated
Sep 26, 2025

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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