BFRT in Adolescents After ACL Reconstruction
ConditionAnterior Cruciate Ligament Rupture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Healthcare of Atlanta
About this trial
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.
Eligibility criteria
Qualifiers
Adolescent male and female patients, age 12-18
Skeletally mature at time of diagnosis, with closed growth plates, as determined via standard clinic x-ray imaging (this specification automatically excludes pre-pubescent children.
Underwent transphyseal ACLR with quadriceps tendon autograft with one of three sports orthopedic surgeons at CHOA
Completed pre-surgery strength assessment of bilateral quadriceps, hamstrings, hip abductor and hip adductor musculature.
Disqualifiers
Skeletally immature patients with open growth plates, as determined via standard clinic x-ray imaging
Concomitant procedures performed during ACLR which require weight-bearing restrictions (i.e. meniscus repair, microfracture, multi-ligament knee reconstruction)
History of previous knee surgery
History of cardiovascular disease (e.g. coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, varicose veins)
Trial design
Treatments tested in this trial
- Blood Flow Restriction using Delfi Personalized Tourniquet System
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov