Using blood flow restriction therapy for lower limb injuries
Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study
NA · NYU Langone Health · NCT04149977
This study is testing if using a special cuff during physical therapy can help people with lower limb injuries build strength and muscle better than those who don’t use the cuff.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04149977 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with lower limb extensor injuries who intend to receive physical therapy.
Not a fit: Patients with severe hypertension, impaired circulation, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve rehabilitation outcomes for patients with lower limb extensor injuries.
How similar studies have performed: While blood flow restriction therapy has shown promise in various conditions, its specific application for lower limb extensor injuries is relatively novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lower Limb Injury