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临床试验/NCT02397161
NCT02397161Unknown不适用

Improving Mental Attention, Timing of Muscle Activation and Reactive Balance Control in Children With Developmental Coordination Disorder: A Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
172
试验地点
1
主要终点
Change in motor control test composite latency score

研究概览

简要总结

Objective: To compare the effectiveness of EEG biofeedback mental attention-neuromuscular training (AT-NMT), neuromuscular training (NMT) alone, EEG biofeedback mental attention training (AT) alone, and no intervention for improving reactive balance performance among children with developmental coordination disorder (DCD).

Design: A single-blinded, randomized controlled clinical trial. Sample: 172 children with DCD. Interventions: AT-NMT, NMT, AT, or no intervention for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and 3-month follow-up. A motor control test (MCT) will give a composite latency score, prefrontal cortex EEG recordings during MCT will measure the mental attention level, and surface electromyography recordings during MCT will indicate the lower limb muscle onset latency.

详细描述

Hypothesis

The Investigators hypothesize that the reactive balance performance in children with DCD can be best improved by treating both their mental attention and neuromuscular deficits.

Objective

To compare the effectiveness of AT-NMT, NMT alone, AT alone, and no intervention for improving reactive balance performance among children with DCD.

Design: A single-blinded, randomized controlled clinical trial. Sample: 172 children with DCD. Interventions: AT-NMT, NMT, AT, or no intervention for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and 3-month follow-up. A motor control test (MCT) will give a composite latency score, prefrontal cortex EEG recordings during MCT will measure the mental attention level, and surface electromyography recordings during MCT will indicate the lower limb muscle onset latency.

Anticipated results and clinical significance: Children with DCD who receive AT-NMT will have the best reactive balance performance outcomes. If the results are positive, this novel training regime can be readily adopted in clinical practice. AT-NMT will improve overall well-being in these children and have positive socio-economic implications such as shorter rehabilitation periods and reduced healthcare costs.

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
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 6 to 9 years old;
  • a formal diagnosis of DCD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) at a child assessment center;
  • a Bruininks-Oseretsky Test of Motor Proficiency giving a gross motor composite score of ≤42;
  • a Child Behavior Checklist attention problem subscale T score of ≥54.5, indicating an attention deficit;
  • attending a local mainstream school;
  • an intelligence level within the normal range; and
  • no experience in using the Brain Computer Interface system or similar apparatus.

排除标准

  • a diagnosis of neurological or other movement disorder;
  • any cognitive, psychiatric (comorbid ADHD will not be excluded), congenital, musculoskeletal or cardiopulmonary disorder that can affect motor performance;
  • receiving active therapies or treatments including complementary and alternative medicine;
  • demonstrating excessive disruptive behavior; or
  • those unable to follow instructions adequately.

结局指标

主要结局

Change in motor control test composite latency score

时间窗: Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months)

次要结局

  • Change in EEG mental attention level(Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months))
  • Change in surface EMG lower limb muscle onset latency(Baseline (0 month), post-intervention (3 months), and 3-month follow-up (6 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shirley S.M. Fong

Assistant Professor, DRPC chairperson

The University of Hong Kong

研究点 (1)

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