BFRT in Adolescents After ACL Reconstruction
ConditionAnterior Cruciate Ligament Rupture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Healthcare of Atlanta
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Blood Flow Restriction using Delfi Personalized Tourniquet System
DeviceParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Test (BFRT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Quadriceps Strength
Quadriceps strength will be evaluated throughout the study using handheld dynamometry and percentage improvement will be compared between the control group and intervention group.
Time frame
0-24 weeks post-surgery2
Hop Test Results
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.
Time frame
24 weeks3
Y-Balance Test Results
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.
Time frame
24 weeksSecondary outcomes
1
Quality of life via Lysholm Knee Scale Score
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.
Time frame
At time of enrollment and 6, 12, and 24 weeks post-surgery2
Discomfort during BFRT via Visual Analogue Scale
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
Time frame
0-16 weeks post-surgery3
Perceived Exertion during BFRT via the Children's OMNI Resistance Training Scale.
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.
Time frame
0-16 weeks post-surgerySponsors and contacts
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Source ClinicalTrials.gov