Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04390035
NA

BFRT in Adolescents After ACL Reconstruction

Sponsor: Children's Healthcare of Atlanta

View on ClinicalTrials.gov

Summary

This is an interventional study that will examine effects of blood flow restriction training (BFRT) in adolescents aged 12-18 after anterior cruciate ligament reconstruction surgery (ACLR). The study aims to identify the effect of BFRT on quadriceps muscle strength and the patient's quality of life, and the overall tolerability of BFRT will be examined. Eight physical therapists at four sports medicine physical therapy (PT) sites will oversee all post-operative PT sessions. Subjects allocated to the BFR group will undergo BFRT, while control group will undergo standard-of-care ACLR rehabilitation, 2 days per week for 16 weeks. Measurements of strength, quality of life, and overall function will be completed at regular intervals.

Official title: Blood Flow Restriction Training in the Adolescent Patient: Effects on Muscle Strength and Overall Function Following Anterior Cruciate Ligament Reconstruction Surgery

Key Details

Gender

All

Age Range

12 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2020-09-23

Completion Date

2023-04

Last Updated

2021-08-02

Healthy Volunteers

Yes

Interventions

DEVICE

Blood Flow Restriction using Delfi Personalized Tourniquet System

Participants assigned to the test group will undergo blood flow restriction training 2 days per week beginning at week 1-2 post-surgery and continuing through week 16 post-surgery using the FDA-approved Delfi Personalized Tourniquet System (PTS) with personalized pressure of 80% of the limb occlusion pressure (LOP). The LOP is the amount of pressure required to fully occlude arterial and venous blood flow to the limb. Otherwise, both the test group and control group will follow a standard 6-month post-surgery rehabilitation protocol which is standard of care for ACLR recovery.

Locations (1)

Children's Healthcare of Atlanta Physical Therapy

Atlanta, Georgia, United States