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临床试验/NCT02754700
NCT02754700已完成2 期

Effects of Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) Training on Risk of Anterior Cruciate Ligament Injury

High Point University0 个研究点目标入组 150 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
150
主要终点
Knee abduction load

研究概览

简要总结

This study will identify the most optimal, focused approach for biofeedback in adolescent females at high risk for anterior cruciate ligament (ACL) injury. A six-week randomized, pre/post-testing design will be used to identify biofeedback training effects. The investigators will also determine the effects of hip strategy on retention of decreased knee abduction load with focused biofeedback. A six-month follow-up design will be used to test retention of real-time biofeedback intervention.

详细描述

Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) represents an innovative new approach to reduce traumatic anterior cruciate ligament (ACL) injuries. Over the last four decades, these debilitating injuries have occurred at a 2 to 10-fold greater rate in female compared to male athletes with the highest prevalence occurring between the ages of 16-18 years. As a consequence, there is a large population of females that endure significant pain, functional limitations and knee osteoarthritis (OA) as early as 5 years after the initial unintentional injury. To reduce the burden of OA, The National Public Health Agenda for Osteoarthritis recommends both expanding and refining evidence-based prevention of ACL injury. There currently is a gap in knowledge regarding how to maximize the effectiveness of injury prevention training in young female athletes. The long-term goal is to reduce ACL injuries in young female athletes. The objective of this application is to increase the efficacy of biofeedback training to reduce the risk of ACL injury. This proposal tests the central hypothesis that biofeedback methodology is needed to maximize the effectiveness of neuromuscular prophylactic interventions. The rationale supporting this proposal is that once the proposed research is completed, health professionals will be more successful at preventing devastating ACL injuries through properly optimized and targeted biofeedback training for young at-risk females. This research is innovative because it represents a new and substantive departure from the status quo by recognizing the need to optimize the application of biofeedback training. The work will contribute clinically relevant data in support of a future more robust clinical trial. The proposed research will be significant because it will lead to reduced rates of ACL injury in young females. Reduction of female injury rates to equal that of males would allow females annually to continue the health benefits of sports participation and avoid the long-term complications of osteoarthritis, which occurs with a 10 to 100-fold greater incidence in ACL-injured than in uninjured athletes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
9 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Currently participating on club or school sponsored soccer team

排除标准

  • Current injury that limits participating in sport
  • Cannot participate in a 6-week intervention due to time or other constraints

研究组 & 干预措施

Biofeedback Hip

Experimental

Hip focused biofeedback with neuromuscular training

干预措施: Hip Focused ROBUST Training (Other)

Biofeedback Knee

Experimental

Knee focused biofeedback with neuromuscular training

干预措施: Knee Focused ROBUST Training (Other)

Neuromuscular Training

Active Comparator

Neuromuscular Training component

干预措施: Neuromuscular Training (Other)

结局指标

主要结局

Knee abduction load

时间窗: 6 weeks

Knee abduction load will be the primary outcome measure. This is assessed with three-dimensional motion analysis techniques and a detailed full-body biomechanical model during dynamic landing tasks immediately before and after 6 weeks of the study intervention. The unit of measure for knee abduction load is Nm and will be normalized to participant mass when appropriate.

次要结局

  • Knee abduction load(6 months)

研究者

申办方类型
Other
责任方
Sponsor

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