A Determination of Efficacy and Therapeutic Benefits of Blood Flow Restriction Training in an Adolescent Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Isometric Quad Strength Peak Torque
研究概览
简要总结
While there are a number studies that have reported on the use of BFR in the adult population, there is limited information about the use of BFR in the adolescent population. This study aims to evaluate the use of BFR training in conjunction with traditional ACL (anterior cruciate ligament) reconstruction rehabilitation in adolescents.
The purpose of this study is to evaluate the addition of BFR-based exercise to traditional methods of physical therapy. Does the use of BFR-based exercise improve strength, hypertrophy, functional and patient reported outcomes after ACL Reconstruction in the adolescent population?
详细描述
The planned pilot study is a prospective case control study utilizing retrospective controls. The investigators will compare the use of exercises augmented with BFR with quantitative measurements of strength and patient reported outcomes. A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study. A review of data from 20 previous patients, matched for age, sex, BMI and surgical procedure that completed physical therapy at Connecticut Children's Sports Physical Therapy will be used as a comparison.
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's, but underwent ACL reconstruction by Elite Sports Medicine. The investigators are unsure of the ability for us to collect prospective controls in a timely manner, hence the investigators will use the above described retrospective cohort as controls if the prospective controls prove difficult to recruit.
Identification and Recruitment:
All potential patients undergoing ACL reconstruction at Elite Sports Medicine will be approached for participation for this study. Eligible patients will be identified at their initial pre-operative appointment with the Sports Medicine Physician, Athletic Trainer, and Sports Physical Therapy Physical Therapist. Subject selection will be completed by those patients meeting the above outlined inclusion and exclusion criteria. At this time, the study purpose and protocol will be explained and a brief summary of the study will be provided.
Consent: Consent will take place at the pre-operative visit. The patient/parent will be given a detailed description of the purpose and methodology for this study. The participants will have the opportunity to read the consent forms and ask any questions they may have about the research. If the patients agree to participate, they will be asked to sign the consent form and a copy will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients between the age of 12 and 18 years at the time of surgery.
- •Post-primary ACL reconstruction
- •Orthopaedic surgical intervention (including all additional procedures at the knee) completed by one of the Elite Sports Medicine physicians.
- •Patient completed postoperative rehabilitation following standard protocols
- •No contraindications to performing BFR, as outlined in the Owens Recovery[18] Science 2018 Personal Blood Flow Restriction manual.
排除标准
- •Patients older than 18 and younger than 12 at the time of surgery
- •Any additional diagnoses or deformity not related to knee injury that could affect knee strength
- •Additional lower extremity injury at time of knee injury (e.g., ankle injury) requiring treatment
- •Previous surgical intervention on the knee (ipsilateral and contralateral)
- •Patients with weight bearing restrictions for greater than two weeks after surgery due to concomitant pathology such as meniscal root/radial repair, chondral pathology, or multi-ligament pathology. . Generic exclusion: "Subjects not meeting all inclusion criteria."
结局指标
主要结局
Isometric Quad Strength Peak Torque
时间窗: 3 month and return to sport post-operative strength (6-8 months post-op)
Isometric strength testing to measure peak torque quadriceps strength (unit: nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isometric Hamstring Strength Peak Torque
时间窗: at 3 months post-op and return to sport (between approximately 6-8 months post-op)
Isometric strength testing to measure peak torque hamstring strength (unit:nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isometric Quad Strength Limb Symmetry Index
时间窗: 3 month and return to sport isometric quad strength limb symmetry
Quadriceps limb symmetry index is calculated by taking the values from outcome 1. \[ ( peak torque quadriceps involved limb (nm-kg)/ peak torque quadriceps uninvolved limb (nm-kg))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry. Should involve limb demonstrate greater strength then uninvolved limb symmetry scores would be greater then 100%
Isometric Hamstring Strength Limb Symmetry Index
时间窗: 3 months post op and return to sport (between approximately 6-8 months post-op)
Hamstring limb symmetry index is calculated by taking the values from outcome 3 \[ ( peak torque hamstring involved limb (nm-kg) / peak torque hamstring uninvolved limb (nm-kg))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal symmetry. For patients that demonstrate a stronger involved limb then uninvolved limb symmetry will be reported as greater then 100%
次要结局
- Pedi-IKDC (International Knee Documentation Committee)(at 3 months post-op and return to sport (between approximately 6-8 months post-op))
研究者
Adam Weaver
Physical Therapist
Connecticut Children's Medical Center