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?
A single randomized control trial will compare the use of exercises augmented with BFRT with quantitative measurements of strength and patient-reported outcomes. A total of 40 youth and adolescent patients undergoing a surgical procedure for ACLR and subsequent physical therapy at our institution will be recruited for this study. Patients will be randomized into one of two groups using computer randomization for allocation: the intervention group receiving BFRT as part of physical therapy, and the control group will follow the institution's standard ACLR rehabilitation protocol. Both groups will follow a time- and criterion-based standardized rehabilitation protocol. The primary outcomes will be isometric and isokinetic knee peak torque and limb symmetry indices. Secondary outcomes will be quadriceps hypertrophy via mid-thigh circumference and patient-reported outcomes. Target Population Adolescent patients between the ages of 12 and 18 will be recruited at the time of surgery, specifically, those that participate in sports who are undergoing primary ACLR reconstruction at Connecticut Children's Study Group and Control Group Inclusion Criteria · 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 I Sports (4-7 days/week) Jumping, hard pivoting, cutting (basketball, volleyball, football, soccer, gymnastics, skiing. wrestling) Running, twisting, turning (racquet sports, baseball, hockey) Level II sports (1-3 days/week) Jumping, hard pivoting, cutting (basketball, volleyball, football, soccer, gymnastics, skiing. wrestling) Running, twisting, turning (racquet sports, baseball, hockey) * Completion of postoperative rehabilitation following standard protocols * Orthopedic surgical intervention and physical therapy completed at Connecticut Children's.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The 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.
Connecticut Children's Sports Physical Therapy
Farmington, Connecticut, United States
RECRUITINGRange 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
Time frame: Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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.
Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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.
Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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.
Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Isometric Hamstring Strength Limb Symmetry Index
Hamstring limb symmetry index is calculated by taking the values from outcome 3 \[ ( peak torque hamstring involved limb (ft/lbs) / peak torque hamstring uninvolved limb (ft-lbs))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal perfect symmetry.
Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Isokinetic Quadriceps strength
Isokinetic strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Time frame: Change in strength at 6 months and 9 months post-op
Isokinetic 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.
Time frame: Change in strength at 6 months and 9 months post-op
Isokinetic Hamstrings Strength
Isokinetic strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Time frame: Change in strength at 6 months and 9 months post-op
Isokinetic Hamstring Strength limb symmetry index
Hamstring 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.
Time frame: Change in strength at 6 months and 9 months post-op
Quadriceps Hypertrophy
Thigh Circumference measured at location 10cm superior to patella and measured in cm comparing involved to uninvolved lower extremity
Time frame: Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op
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).
Time frame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
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
Time frame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
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
Time frame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
Tegner Activity Scale
Tegner activity scale will measure sport level- higher level equals higher sport competitive level
Time frame: changes from pre-operative, 9 months, and 2 years post-operative
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