Using blood flow restriction therapy for lower limb injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of blood flow restriction therapy in enhancing strength and muscle mass in patients with lower limb extensor injuries. The therapy involves applying an inflatable cuff to restrict venous outflow during physical therapy exercises, creating a high-intensity environment that promotes muscle hypertrophy. Participants will undergo physical therapy with either a pressure cuff or a placebo cuff, with their progress monitored through pre and post-treatment assessments. The study seeks to fill a gap in existing literature regarding the application of this therapy for specific lower limb injuries.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Guillem Gonzales-Lomas, MD — NYU Langone
• Study coordinator: Samy Shelbaya
• Email: Samy.shelbaya@nyulangone.org
• Phone: 517-575-5522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.