Blood Flow Restriction Therapy for Lower Limb Extensor Injuries

This study is looking at how well Blood Flow Restriction Therapy helps people with lower limb extensor injuries, such as tears in the quadriceps or patella tendons, or patella fractures. You could be eligible if you are between 18 and 65 years old, generally healthy (ASA class I-II), and plan to have physical therapy. Participants will receive 6 weeks of physical therapy, either with a pressure cuff that restricts blood flow or a cuff with less pressure (placebo). Researchers will measure the strength in both your legs at the beginning and after 6 weeks to see if the therapy helps improve strength. The study aims to enroll 128 people, but its current status is unclear.

Study design
This interventional study plans to enroll 128 participants. It compares two groups: one receiving physical therapy with a pressure cuff, and another receiving physical therapy with a placebo pressure cuff.
What's involved
You would participate in 6 weeks of physical therapy. Your leg strength will be measured at the start of the study and again after 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your leg strength will be measured at the start of the study and at the end of the 6-week physical therapy period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04149977

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

Recruiting
NAAges 18–65InterventionalTreatment
NYU Langone Health
~128 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:Physical Therapy with pressure cuffPhysical Therapy with placebo pressure cuff

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in extensor strength of both legs
Measured over Visit 1 Day 0
+1 more outcome measured
Lower Limb Injury

NCT04149977

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • NYU Langone Health

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Guillem Gonzales-Lomas, MD · PRINCIPAL_INVESTIGATOR · NYU Langone

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Eligibility criteria

Inclusion

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

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
  • Change in extensor strength of both legsVisit 1 Day 0

    Isokinetic strength testing with a Biodex dynamometer to measure peak torque

  • Change in extensor strength of both legsVisit 3 week 6

    Isokinetic strength testing with a Biodex dynamometer to measure peak torque