Clinical Trial

BFRT in Adolescents After ACL Reconstruction

Recruiting

Record status

This record was last updated August 2, 2021 (before its estimated April 2023 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2020-05-14; most recent amendment 2024-04-17.

Status change: Recruiting → Completed 2024-04-17

Status change: Not Yet Recruiting → Recruiting 2021-01-20

Trial Details

NCT Number	NCT04390035
Lead Sponsor	Children's Healthcare of Atlanta
Conditions	Anterior Cruciate Ligament Rupture
Enrollment	120 participants
Start Date	2020-09-23
Primary Completion	2023-04 (estimated)
Study Completion	2023-04 (estimated)
Updated on ClinicalTrials.gov	2021-08-02