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BFRT in Adolescents After ACL Reconstruction

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2020 to Sep 23, 2020
    • Site details revised
    v3
  3. Start date: Jun 2020 to Jul 2020
    • Interventions: Blood Flow Restriction Training (Device) to Blood Flow Restriction using Delfi Personalized Tourniquet System (Device)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04390035
Lead Sponsor Children's Healthcare of Atlanta
Conditions
(from sponsor)		 Anterior Cruciate Ligament Rupture
Related terms Anterior Cruciate Ligament Injuries
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov