BFRT in Adolescents After ACL Reconstruction
Children's Healthcare of Atlanta · NCT04390035
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12–18 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 120
- US sites recruiting
- 1
- Study start
- September 23, 2020
- Record last updated
- August 2, 2021
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Blood Flow Restriction using Delfi Personalized Tourniquet System
Conditions: Anterior Cruciate Ligament Rupture
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Adolescent male and female patients, age 12-18
- 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.
- Underwent transphyseal ACLR with quadriceps tendon autograft with one of three sports orthopedic surgeons at CHOA
- Completed pre-surgery strength assessment of bilateral quadriceps, hamstrings, hip abductor and hip adductor musculature.
- 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
- Skeletally immature patients with open growth plates, as determined via standard clinic x-ray imaging
- Concomitant procedures performed during ACLR which require weight-bearing restrictions (i.e. meniscus repair, microfracture, multi-ligament knee reconstruction)
- History of previous knee surgery
- History of cardiovascular disease (e.g. coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, varicose veins)
- 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
- Inability to adhere to treatment protocol (as described in study procedures, BFR-LLT treatment requirements)
- Any adverse events intra-operatively or post-operatively that lead to delay in care, including infection
- 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
Recruiting US locations
Children's Healthcare of Atlanta Physical Therapy
Atlanta, GA 30342-3269
Site contact: Jeanne Graf, PT, DPT, ATC · 404-785-8421 · jeannie.graf@choa.org
Study contacts (from the official record)
- Jeanne Graf, PT, DPT, ATC · 404-785-8421 · jeannie.graf@chao.org
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