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Trial record 1 of 1 for:    blood flow restriction | ( Map: Georgia, United States )
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BFRT in Adolescents After ACL Reconstruction

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ClinicalTrials.gov Identifier: NCT04390035
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Jeanne Graf, Children's Healthcare of Atlanta

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Device: Blood Flow Restriction using Delfi Personalized Tourniquet System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized into either a control group or the test group at time of enrollment at a 1:1 ratio. Participants will undergo standard post-surgery rehabilitation (control group) or standard post-surgery rehabilitation with supplemental blood flow restriction (test group).
Masking: None (Open Label)
Masking Description: Given that the intervention involves a device that will be physically applied to the participant's post-operative leg, masking is not feasible for this study.
Primary Purpose: Treatment
Official Title: Blood Flow Restriction Training in the Adolescent Patient: Effects on Muscle Strength and Overall Function Following Anterior Cruciate Ligament Reconstruction Surgery
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Participants in the control arm will follow the standard-of-care treatment exercises for the 6 months following ACL reconstruction surgery.
Experimental: Test (BFRT)
Participants in the test arm will follow the identical physical therapy exercises as the control arm but will perform the exercises with BFRT during the first 16 weeks post-surgery. After reaching the 16-week mark, participants will complete the identical standard-of-care rehabilitation between weeks 16-24.
Device: Blood Flow Restriction using Delfi Personalized Tourniquet System
Participants assigned to the test group will undergo blood flow restriction training 2 days per week beginning at week 1-2 post-surgery and continuing through week 16 post-surgery using the FDA-approved Delfi Personalized Tourniquet System (PTS) with personalized pressure of 80% of the limb occlusion pressure (LOP). The LOP is the amount of pressure required to fully occlude arterial and venous blood flow to the limb. Otherwise, both the test group and control group will follow a standard 6-month post-surgery rehabilitation protocol which is standard of care for ACLR recovery.




Primary Outcome Measures :
  1. Quadriceps Strength [ Time Frame: 0-24 weeks post-surgery ]
    Quadriceps strength will be evaluated throughout the study using handheld dynamometry and percentage improvement will be compared between the control group and intervention group.

  2. Hop Test Results [ Time Frame: 24 weeks ]
    The hop test battery includes four hop tests (single leg hop for distance, triple hop for distance, 6-meter timed hop, triple crossover hop). Symmetry of performance between operative and non-operative lower extremity will be compared between control group and intervention group. The test will be performed at 24 weeks post-surgery.

  3. Y-Balance Test Results [ Time Frame: 24 weeks ]
    Symmetry of performance between operative and non-operative lower extremity will be compared between control group and intervention group. This test will be performed at 24 weeks post-surgery.


Secondary Outcome Measures :
  1. Quality of life via Lysholm Knee Scale Score [ Time Frame: At time of enrollment and 6, 12, and 24 weeks post-surgery ]
    The Lysholm Knee Scoring Scale is a patient-reported outcome which will be used to assess participant quality of life throughout the recovery following surgery. This tool asks eight questions and the score total ranges from 0-100 with 100 being the better outcome.

  2. Discomfort during BFRT via Visual Analogue Scale [ Time Frame: 0-16 weeks post-surgery ]
    The Visual Analogue scale is a patient-reported outcome, the score ranges from 0 - 10, with 0 being no pain. Pain level pre-treatment and during training will be assessed at each session

  3. Perceived Exertion during BFRT via the Children's OMNI Resistance Training Scale. [ Time Frame: 0-16 weeks post-surgery ]
    The children's OMNI resistance training scale is a patient-reported outcome, the score ranges from 0 - 10, with 0 being no exertion. Perceived exertion will be assessed at each treatment session.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390035


Contacts
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Contact: Jeanne Graf, PT, DPT, ATC 404-785-8421 jeannie.graf@chao.org

Locations
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United States, Georgia
Children's Healthcare of Atlanta Physical Therapy
Atlanta, Georgia, United States, 30342-3269
Contact: Jeanne Graf, PT, DPT, ATC    404-785-8421    jeannie.graf@choa.org   
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
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Principal Investigator: Jeanne Graf, PT, DPT, ATC Clinical Site Supervisor, Physical Therapist
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Responsible Party: Jeanne Graf, Clinical Site Supervisor, Physical Therapist, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT04390035    
Other Study ID Numbers: STUDY00000434
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jeanne Graf, Children's Healthcare of Atlanta:
Adolescents
Blood Flow Restriction Training
Patient-reported Outcomes
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries