BFRT in Adolescents After ACL Reconstruction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04390035|
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Rupture||Device: Blood Flow Restriction Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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.|
|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 :||June 2020|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
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 Training
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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
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
|Contact: Jeanne Graf, PT, DPT, ATCfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Jeanne Graf, PT, DPT, ATC||Clinical Site Supervisor, Physical Therapist|