NCT04390035 BFRT in Adolescents After ACL Reconstruction
| NCT ID | NCT04390035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Healthcare of Atlanta |
| Condition | Anterior Cruciate Ligament Rupture |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-09-23 |
| Primary Completion | 2023-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2020-09-23 with a primary completion date of 2023-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jeanne Graf, PT, DPT, ATC
PRINCIPAL INVESTIGATOR
Clinical Site Supervisor, Physical Therapist
Frequently Asked Questions
Who can join the NCT04390035 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Anterior Cruciate Ligament Rupture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04390035 currently recruiting?
Yes, NCT04390035 is actively recruiting participants. Contact the research team at jeannie.graf@chao.org for enrollment information.
Where is the NCT04390035 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT04390035 clinical trial?
NCT04390035 is sponsored by Children's Healthcare of Atlanta. The principal investigator is Jeanne Graf, PT, DPT, ATC at Clinical Site Supervisor, Physical Therapist. The trial plans to enroll 120 participants.