Actively Recruiting
Blood Flow Restriction Training in Adolescents After Anterior Cruciate Ligament Reconstruction Surgery: Effects on Muscle Strength and Function
Led by Children's Healthcare of Atlanta · Updated on 2021-08-02
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating blood flow restriction training (BFRT) in adolescents aged 12 to 18 following anterior cruciate ligament reconstruction surgery (ACLR). This study aims to understand how BFRT affects quadriceps muscle strength, overall function, and quality of life in these patients. The research focuses on determining the tolerability and benefits of BFRT compared to standard post-surgery rehabilitation. It addresses a critical need as adolescents have higher risks of reinjury and persistent muscle weakness despite current therapy approaches. Participants are randomly assigned to one of two groups: a control group receiving standard physical therapy and a test group receiving the same physical therapy supplemented with BFRT. Both groups attend two physical therapy visits weekly for 16 weeks, with the test group performing exercises using the Delfi Personalized Tourniquet System to partially restrict blood flow during training. After 16 weeks, both groups continue standard rehabilitation until 24 weeks post-surgery. Physical therapists trained in the protocol oversee all sessions, which last about 60 minutes each. Throughout the study, participants complete strength tests, functional hop and balance assessments, and four patient-reported outcome questionnaires at multiple time points up to 24 weeks. Researchers also monitor discomfort and exertion during BFRT sessions. Data collection includes demographic, physiological, and radiographic information stored securely. The study's total duration for each participant is six months, allowing comprehensive evaluation of muscle strength recovery and quality of life after ACLR surgery with or without BFRT.
CONDITIONS
Brief Title
BFRT in Adolescents After ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents aged 12 to 18 years
- Skeletally mature with closed growth plates confirmed by x-ray imaging
- Underwent ACL reconstruction surgery with quadriceps tendon autograft by a CHOA orthopedic surgeon
- Completed pre-surgery strength assessment of quadriceps, hamstrings, hip abductors, and 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 reconstruction requiring weight-bearing restrictions
- History of previous knee surgery
- History of cardiovascular disease such as coronary artery disease or unstable hypertension
- Diagnosed bleeding disorders or use of blood clotting medications
- Unable to follow the treatment protocol or attend required physical therapy visits
- Any complications during or after surgery causing care delays, including infection
- Failure to attend first physical therapy visit within 5 days post-surgery or less than 20 visits during weeks 1-16 post-surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks post-surgery
Participants begin their post-surgery physical therapy rehabilitation. Those assigned to the test group perform exercises supplemented with blood flow restriction training using a personalized tourniquet system. Participants attend physical therapy visits twice a week, with each session lasting about 60 minutes. This treatment lasts from 2-5 days post-surgery through 16 weeks post-surgery.
Twice-weekly visits for up to 16 weeks
Duration - Weeks 17 to 24 post-surgery
After completing the initial treatment phase, participants continue standard post-surgery rehabilitation without blood flow restriction through week 24 post-surgery and complete functional testing and patient-reported outcome assessments.
Additional visits as part of standard care up to 24 weeks post-surgery
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here