Blood flow restriction training for adolescents after ACL surgery
Blood Flow Restriction Training in the Adolescent Patient: Effects on Muscle Strength and Overall Function Following Anterior Cruciate Ligament Reconstruction Surgery
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Healthcare of Atlanta Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04390035 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 who have undergone ACL reconstruction with closed growth plates.
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.
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 performed: Previous studies have shown promising results with blood flow restriction training in various populations, suggesting potential for success in this novel application.
Eligibility criteria
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 this trial is running
Atlanta, Georgia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.