RECRUITING

Blood Flow Restriction Therapy in Lower Limb Extensor Injuries

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-01

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04149977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Michael Moore

CONTACT

347-554-0183

Michael.Moore@nyulangone.org

Principal Investigator

Guillem Gonzales-Lomas, MD

PRINCIPAL_INVESTIGATOR

NYU Langone

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Guillem Gonzales-Lomas, MD, PRINCIPAL_INVESTIGATOR, NYU Langone

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-01

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-09-01

Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

Lower Limb Injury