The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Isometric Quadriceps Strength limb symmetry index
研究概览
简要总结
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?
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Isometric Quadriceps Strength limb symmetry index
时间窗: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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 Limb Symmetry Index
时间窗: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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.
Range of Motion
时间窗: Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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
时间窗: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Isometric strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isometric Hamstring Strength Peak Torque
时间窗: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Isometric strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isokinetic Quadriceps strength
时间窗: Change in strength at 6 months and 9 months post-op
Isokinetic strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isokinetic Hamstrings Strength
时间窗: Change in strength at 6 months and 9 months post-op
Isokinetic strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isokinetic Quadriceps Strength limb symmetry index
时间窗: Change in strength at 6 months and 9 months post-op
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.
Isokinetic Hamstring Strength limb symmetry index
时间窗: Change in strength at 6 months and 9 months post-op
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.
次要结局
- Tegner Activity Scale(changes from pre-operative, 9 months, and 2 years post-operative)
- Quadriceps Hypertrophy(Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op)
- Anterior Cruciate Ligament- Return to Sport after Injury(Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op)
- Pediatric International Knee Documentation Committee(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(Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op)