About this trial
While there are a number studies that have reported on the use of blood flow restriction training (BFRT) in the adult population, there is limited information about the use of BFRT in the adolescent population. This study aims to evaluate the use of BFRT in conjunction with traditional anterior ligament reconstruction (ACLR) rehabilitation in adolescents.
The purpose of this study is to compare the addition of a BFRT based exercise protocol to a standard ACL rehabilitation protocol in adolescents. Does the addition of BFRT-based exercise improve strength, hypertrophy, and patient reported outcomes after ACLR in the adolescent population?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Prior to surgery participated in >50 hours/year of level I or II sports as defined by Noyes et al and planned to return to prior level.
Level II sports (1-3 days/week) Jumping, hard pivoting, cutting (basketball, volleyball,football, soccer, gymnastics, skiing. wrestling)
Completion of postoperative rehabilitation following standard protocols
Orthopedic surgical intervention and physical therapy completed at Connecticut Children's.
Disqualifiers
An additional lower extremity injury at time of knee injury or previous surgical intervention on the knee (ipsilateral and contralateral)
Multiple ligament ruptures or trauma
Weight bearing restrictions for greater than 4 weeks after surgery due to concomitant pathology such as meniscal root/radial repair, chondral pathology, or multi-ligament pathology
Follow-up surgical procedures including, but not limited to, post-operative arthrofibrosis Inability to attend regular physical therapy sessions (≥80% of patient treatment sessions and all assessment visits
Trial design
Parallel
Treatments tested in this trial
Blood Flow Restriction using Delfi Personalized Tourniquet System
DeviceThe Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device.
Treatment groups
Trial outcomes
Primary outcomes
Range of Motion
Active knee range of motion: Knee AROM will be measured in supine position using a goniometer and standardized procedures reported by Norkin and White
Isometric Quad strength Peak Torque
Isometric strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isometric Quadriceps Strength limb symmetry index
Quadriceps limb symmetry index is calculated by taking the values from outcome 1. \[ ( peak torque quadriceps involved limb (ft/lbs)/ peak torque quadriceps uninvolved limb (ft-lbs))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry.
Isometric Hamstring Strength Peak Torque
Isometric strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Secondary outcomes
Quadriceps Hypertrophy
Thigh Circumference measured at location 10cm superior to patella and measured in cm comparing involved to uninvolved lower extremity
Pediatric International Knee Documentation Committee
Patient Reported Outcome Measure- Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Knee Outcomes and Osteoarthritis Scale
Patient Reported Outcome Measure- The score is a percentage score from 0 to 100, with 0 representing extreme problems and 100 representing no problems. This scoring direction, 100 indicating no problems
Anterior Cruciate Ligament- Return to Sport after Injury
Patient Reported Outcome Measure- The scores range from 0 to 100, with higher scores representing patients who are more ready to return to sport
Sponsors and contacts
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Connecticut Children's Medical Center
Lead sponsor
University of Connecticut
Collaborator