Clinical trial NCT04149977: Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
Official title: Blood Flow Restriction Therapy in Lower Limb Extensor Injuries: A Randomized Controlled Double-Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Limb Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The purpose is to restrict venous outflow with an inflatable cuff to create a high intensity environment increases muscle hypertrophy, thus promoting a more efficient form of rehabilitation. Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff. The cuff is placed around the desired limb before a specific exercise, the physical therapist determines the appropriate pressure and time, and the patient completes the exercise as they normally would. The monitor determines the limb occlusion pressure and has an automatic timer that will deflate after the specified time has elapsed. There are also audio and visual alarms that alert the user of under or over pressurization. The specific pressure will vary based on patient's tolerance and will stay consistent through each exercise. Thus far blood flow restriction therapy has been tested in patients with several pathologies but there is limited literature on its effect on lower limb extensor injuries.

Eligibility 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

Primary outcomes:
measure: Change in extensor strength of both legs
timeFrame: Visit 1 Day 0
measure: Change in extensor strength of both legs
timeFrame: Visit 3 week 6
Secondary outcomes:
measure: Change in recovery, muscle strength
timeFrame: Visit 1 Day 0
measure: Change in recovery, muscle strength
timeFrame: Visit 1 Week 6
measure: Change in Knee function
timeFrame: Visit 1 Day 0
measure: Change in Knee function
timeFrame: Visit 3 week 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone
name: Guillem Gonzales-Lomas, MD
role: PRINCIPAL_INVESTIGATOR
References: