BFRT in Adolescents After ACL Reconstruction

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Children's Healthcare of Atlanta
Study ID
NCT04390035
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Rupture

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Blood Flow Restriction using Delfi Personalized Tourniquet System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 23, 2020
Status verified
Jul 2021
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    Participants in the control arm will follow the standard-of-care treatment exercises for the 6 months following ACL reconstruction surgery.
  • Experimental: Test (BFRT)
    Participants in the test arm will follow the identical physical therapy exercises as the control arm but will perform the exercises with BFRT during the first 16 weeks post-surgery. After reaching the 16-week mark, participants will complete the identical standard-of-care rehabilitation between weeks 16-24.

Primary Outcome Measure

Quadriceps Strength [ Time Frame: 0-24 weeks post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Healthcare of Atlanta Physical TherapyAtlantaGeorgia30342-3269
Jeanne Graf, PT, DPT, ATC
[email protected]
404-785-8421

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By research site
Children's Healthcare of Atlanta Physical Therapy· Atlanta, GA

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