Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

NCT04149977 | Recruiting DMC

• 1 other identifier: 19-01269
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Injury

Outcome Measures

Primary Outcomes (2)

• Change in extensor strength of both legs

  Isokinetic strength testing with a Biodex dynamometer to measure peak torque

  Visit 1 Day 0

• Change in extensor strength of both legs

  Isokinetic strength testing with a Biodex dynamometer to measure peak torque

  Visit 3 week 6

Secondary Outcomes (4)

• Change in recovery, muscle strength

  Visit 1 Day 0

• Change in recovery, muscle strength

  Visit 1 Week 6

• Change in Knee function

  Visit 1 Day 0

• Change in Knee function

  Visit 3 week 6

Study Arms (2)

blood flow restriction therapy (pressure cuff)

EXPERIMENTAL

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.

Behavioral: Physical Therapy with pressure cuff

blood flow restriction therapy (placebo)

PLACEBO COMPARATOR

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

Behavioral: Physical Therapy with placebo pressure cuff

Interventions

Physical Therapy with pressure cuff 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 (pressure cuff)

Physical Therapy with placebo pressure cuff 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.

blood flow restriction therapy (placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Leg Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Guillem Gonzales-Lomas, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samy Shelbaya

CONTACT

517-575-5522; Samy.shelbaya@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: September 1, 2021
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.

Locations

US (1)