BFRT in Adolescents After ACL Reconstruction

Description

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.

Conditions

Anterior Cruciate Ligament Rupture

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Study Overview

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Study Details

Study overview

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.

Blood Flow Restriction Training in the Adolescent Patient: Effects on Muscle Strength and Overall Function Following Anterior Cruciate Ligament Reconstruction Surgery

BFRT in Adolescents After ACL Reconstruction

Condition
Anterior Cruciate Ligament Rupture
Intervention / Treatment

-

Contacts and Locations

Atlanta

Children's Healthcare of Atlanta Physical Therapy, Atlanta, Georgia, United States, 30342-3269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

12 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Children's Healthcare of Atlanta,

Jeanne Graf, PT, DPT, ATC, PRINCIPAL_INVESTIGATOR, Clinical Site Supervisor, Physical Therapist

Study Record Dates

2023-04