Recruiting

Blood Flow Restriction

Sponsor:

NYU Langone Health

Code:

NCT04149977

Conditions

Lower Limb Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Physical Therapy with pressure cuff

Physical Therapy with placebo pressure cuff

Study Details

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.

Conditions

Lower Limb Injury

Study ID

NCT04149977

Start date

Sep 1, 2021

Status verified date

Sep, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Feb 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

Interventions

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.

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.

Primary outcome measure

  • Change in extensor strength of both legs [ Time Frame: Visit 1 Day 0 ]
  • Change in extensor strength of both legs [ Time Frame: Visit 3 week 6 ]

Central Contacts and Locations

Central contacts

Samy Shelbaya

517-575-5522Samy.shelbaya@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Dhruv Shankar

240-848-8645dhruv.shankar@nyulangone.org

Principal Investigator:

Guillem Gonzalez-Lomas, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-09-26.