Blood flow restriction training for adolescents after ACL surgery
Official title: Blood Flow Restriction Training in the Adolescent Patient: Effects on Muscle Strength and Overall Function Following Anterior Cruciate Ligament Reconstruction Surgery
Run by Children's Healthcare of Atlanta · NCT04390035 · Data updated 2026-11-12
This study is testing if blood flow restriction training can help teenagers recover better and get stronger after ACL surgery compared to regular rehab.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 18 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Children's Healthcare of Atlanta Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | September 23, 2020 |
| Main results expected | April 2023 |
| Study ends | April 2023 |
| Registry record updated | August 2, 2021 |
| Trial ID | NCT04390035 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adolescents aged 12-18 who have undergone ACL reconstruction with closed growth plates.
✕Probably not a fit
Patients who are skeletally immature with open growth plates or have undergone additional procedures requiring weight-bearing restrictions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study investigates the effects of blood flow restriction training (BFRT) on adolescents aged 12-18 who have undergone anterior cruciate ligament reconstruction (ACLR). Participants will be divided into two groups: one receiving BFRT and the other undergoing standard rehabilitation. The study will assess improvements in quadriceps muscle strength, quality of life, and overall tolerability of the BFRT approach over a 16-week period. Eight physical therapists will oversee the rehabilitation sessions at four sports medicine physical therapy sites, with regular measurements taken to evaluate outcomes.
Why it matters
Potential benefit: If successful, this approach could enhance muscle strength and quality of life for adolescents recovering from ACL surgery.
How similar studies have gone: Previous studies have shown promising results with blood flow restriction training in various populations, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adolescent male and female patients, age 12-18 2. 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. 3. Underwent transphyseal ACLR with quadriceps tendon autograft with one of three sports orthopedic surgeons at CHOA 4. Completed pre-surgery strength assessment of bilateral quadriceps, hamstrings, hip abductor and hip adductor musculature. 5. 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. Exclusion Criteria: 1. Skeletally immature patients with open growth plates, as determined via standard clinic x-ray imaging 2. Concomitant procedures performed during ACLR which require weight-bearing restrictions (i.e. meniscus repair, microfracture, multi-ligament knee reconstruction) 3. History of previous knee surgery 4. History of cardiovascular disease (e.g. coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, varicose veins) 5. 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 6. Inability to adhere to treatment protocol (as described in study procedures, BFR-LLT treatment requirements) 7. Any adverse events intra-operatively or post-operatively that lead to delay in care, including infection 8. 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's running
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Children's Healthcare of Atlanta Physical Therapy
Atlanta, Georgia, United States Recruiting
Study contacts
- Principal investigator: Jeanne Graf, PT, DPT, ATC — Clinical Site Supervisor, Physical Therapist
- Study coordinator: Jeanne Graf, PT, DPT, ATC
- Email: jeannie.graf@chao.org
- Phone: 404-785-8421
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Quadriceps tendon vs peroneus longus tendon grafts for ACL reconstruction
This randomized trial tests whether using a quadriceps tendon autograft works as well as a peroneus longus tendon autograft for ACL reconstruction in adults, looking at knee function and donor-site effects.
-
Proprioceptive exercises to aid recovery after ACL surgery
This trial will see if adding proprioceptive exercises to standard balance training helps people aged 20–40 during the early rehab period after ACL surgery.
-
All-inside versus complete tibial tunnel ACL reconstruction using hamstring grafts
This trial will test whether the all-inside or the complete tibial tunnel surgical technique leads to better recovery in adults (18–65) having ACL reconstruction with hamstring grafts.
-
Cross bracing versus early ACL reconstruction for recent ACL rupture
This will try whether a 12-week cross bracing program plus supervised physiotherapy helps people aged 16–40 with a recent complete ACL tear more than early ACL reconstruction surgery.
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Hockey slideboard training with blood flow restriction for ACL rehabilitation
This study is testing if combining hockey slideboard training with blood flow restriction can help people recover better and safer after ACL surgery.
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Using a robotic system to improve ACL surgery precision
This study tests if using a robotic system during ACL surgery can make the surgery more accurate and improve recovery for patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.