BFRT in Adolescents After ACL Reconstruction

Recruiting now · Not applicable

Conditions studied: Anterior Cruciate Ligament Rupture

In brief

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 facts

Study ID

NCT04390035

Run by

Children's Healthcare of Atlanta

People needed

120

Starts

2020-09-23

Expected to finish

2023-04-01

Last updated by the study team

2021-08-02

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• English-speaking adolescents and parents of all races and ethnicities (after preliminary data is achieved, PI will coordinate a larger multi-center study that will include all non-English speaking participants.

You may not qualify if…

• 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)
• ICD-10 diagnosis of bleeding disorder (e.g. hemophilia or blood clotting disorder) or use of anticoagulants or other medications that may affect blood clotting
• Inability to adhere to treatment protocol (as described in study procedures, BFR-LLT treatment requirements)
• Any adverse events intra-operatively or post-operatively that lead to delay in care, including infection
• Failure to adhere to attendance requirements as detailed below:
• Attend first PT visit (PTV) within 5 days post-surgery
• Attend a minimum of 20 total PTVs during weeks 1-16 post-surgery

Where it is running

• Children's Healthcare of Atlanta Physical Therapy — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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