Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

NYU Langone Health

Status: Enrolling

Conditions: Lower Limb Injury

Treatments: Behavioral: Physical Therapy with placebo pressure cuff; Behavioral: Physical Therapy with pressure cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT04149977

19-01269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

blood flow restriction therapy (pressure cuff)

Experimental group

Description:

The cuff will be placed around the upper thigh of the injured leg and set at a pressure that will prevent approximately 80% arterial blood flow. The machine will determine what pressure is required to reach that 80%, when placed on the leg and turned on.

Treatment:

Behavioral: Physical Therapy with pressure cuff

blood flow restriction therapy (placebo)

Placebo Comparator group

Description:

Patients with a placebo pressure will have a pressure setting, 50% lower than the effective setting as stated in the experimental arm

Treatment:

Behavioral: Physical Therapy with placebo pressure cuff