Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

NCT ID: NCT04149977

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2026-06-01

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.

Conditions

Lower Limb Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

blood flow restriction therapy (pressure cuff)

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.

Group Type: EXPERIMENTAL

Physical Therapy with pressure cuff

Intervention Type: BEHAVIORAL

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.

blood flow restriction therapy (placebo)

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

Group Type: PLACEBO_COMPARATOR

Physical Therapy with placebo pressure cuff

Intervention Type: BEHAVIORAL

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.

Interventions

Physical 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.

Intervention Type: BEHAVIORAL

Physical 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillem Gonzales-Lomas, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samy Shelbaya

Role: CONTACT

Samy.shelbaya@nyulangone.org

517-575-5522

Facility Contacts

Dhruv Shankar

Role: primary

dhruv.shankar@nyulangone.org

240-848-8645

Other Identifiers

19-01269

Identifier Type: -

Identifier Source: org_study_id