Anterior Cruciate Ligament Injuries Clinical Trial
Official title:
The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial
NCT number | NCT05754632 |
Other study ID # | 22-139 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 8, 2023 |
Est. completion date | May 1, 2027 |
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?
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 1, 2027 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | 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) - 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. Exclusion Criteria: - 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 - Contraindications to performing BFRT including known history of central or peripheral neurologic impairments, cardiac or metabolic condition or history of deep vein thrombosis (DVT). |
Country | Name | City | State |
---|---|---|---|
United States | Connecticut Children's Sports Physical Therapy | Farmington | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Connecticut Children's Medical Center | University of Connecticut |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op | |
Primary | 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. | Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op | |
Primary | 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. | Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op | |
Primary | 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. | Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op | |
Primary | 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. | Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op | |
Primary | 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. | Change in strength at 6 months and 9 months post-op | |
Primary | 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. | Change in strength at 6 months and 9 months post-op | |
Primary | 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. | Change in strength at 6 months and 9 months post-op | |
Primary | 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. | Change in strength at 6 months and 9 months post-op | |
Secondary | Quadriceps Hypertrophy | Thigh Circumference measured at location 10cm superior to patella and measured in cm comparing involved to uninvolved lower extremity | Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op | |
Secondary | 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). | Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op | |
Secondary | 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 | Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op | |
Secondary | 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 | Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op | |
Secondary | Tegner Activity Scale | Tegner activity scale will measure sport level- higher level equals higher sport competitive level | changes from pre-operative, 9 months, and 2 years post-operative |
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