Clinical trial Recruiting at 1 site Interventional Ages 12 to 18

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 typeInterventional
Ages12 Years to 18 Years
SexAll
Enrollment120 (estimated)
SponsorChildren's Healthcare of Atlanta
Academic / other
Locations1 site (Atlanta, Georgia)
StatusRecruiting
StartedSeptember 23, 2020
Main results expectedApril 2023
Study endsApril 2023
Registry record updatedAugust 2, 2021
Trial IDNCT04390035 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

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.