RecruitingNot ApplicableNCT04149977

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

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


Sponsor

NYU Langone Health

Enrollment

128 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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

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Interventions

BEHAVIORALPhysical 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.

BEHAVIORALPhysical 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.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT04149977


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