Actively Recruiting
BFRT in Adolescents After ACL Reconstruction
Led by Children's Healthcare of Atlanta · Updated on 2021-08-02
120
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BFRT in Adolescents After ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescent male and female patients aged 12 to 18 years
- Skeletally mature with closed growth plates confirmed by X-ray
- Underwent transphyseal ACL reconstruction with quadriceps tendon autograft by specified orthopedic surgeons
- Completed pre-surgery strength assessment of quadriceps, hamstrings, hip abductors, and hip adductors
- English-speaking adolescents and parents of all races and ethnicities
You will not qualify if you...
- Skeletally immature patients with open growth plates
- Underwent additional procedures during ACL surgery requiring weight-bearing restrictions (e.g., meniscus repair, microfracture, multi-ligament reconstruction)
- History of previous knee surgery
- History of cardiovascular disease such as coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, or varicose veins
- Diagnosed bleeding disorders or use of blood clotting medications
- Inability to follow the treatment protocol including blood flow restriction training requirements
- Any surgical or post-operative complications causing delay in care, including infection
- Failure to attend the first physical therapy visit within 5 days post-surgery or attend at least 20 therapy visits during weeks 1 to 16 after surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Healthcare of Atlanta Physical Therapy
Atlanta, Georgia, United States, 30342-3269
Actively Recruiting
Research Team
J
Jeanne Graf, PT, DPT, ATC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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