跳至主要内容
临床试验/NCT03838614
NCT03838614Unknown不适用

Rhythmical Auditory Stimulation Gait Training and Muscle Power Training for Primary School 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 76 人开始时间: 2019年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
76
试验地点
1
主要终点
Changes in spatiotemporal gait parameter - stride length (cm)

研究概览

简要总结

Objectives: To compare the effectiveness of RAS-MPT, RAS alone, MPT alone, and usual care (as a control) for improving the overall gait performance of and reducing falls in children with developmental coordination disorder (DCD) and to explore the relationship between gait performance and falls in this population.

Design: A randomized controlled trial. Sample: 76 children with DCD. Interventions: RAS-MPT, RAS alone, MPT alone, or usual care (12 weeks). Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and a 6-month follow-up. Comprehensive gait analysis will produce spatiotemporal gait parameters (e.g., velocity and stride length), kinematic gait parameters (e.g., knee joint motions), and leg muscle EMG outcomes; an isokinetic test will quantify leg muscle strength and force production time; and fall histories will be obtained via interviews. Anticipated results and significance: The RAS-MPT group is predicted to display the best gait performance, which is associated with reduced fall incidents. This novel training regime can be readily adopted in school, clinical, or home settings to improve locomotor ability in children with DCD, an outcome with positive socioeconomic implications.

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
  • classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V
  • < 5th percentile on the Movement Assessment Battery for Children-2 (MABC-2)
  • a total score of < 46 (for children aged 6 to 7 years 11 months) or < 55 (for children aged 8 to 9 years) on the DCD questionnaire 2007 (Chinese version)
  • attending a mainstream school (i.e., intelligence level within the normal range).

排除标准

  • any congenital, cognitive, psychiatric (e.g., comorbid attention deficit hyperactivity disorder or autism spectrum disorder), neurological, sensory, hearing, visual, vestibular, musculoskeletal, or cardiopulmonary disorder that may affect test performance
  • obesity (body mass index [BMI] >95th percentile)
  • receiving active treatment such as physiotherapy
  • those unable to follow instructions.

研究组 & 干预措施

RAS-MPT group

Experimental

Rhythmical auditory stimulation gait training and muscle power training group

干预措施: Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT) (Behavioral)

RAS group

Experimental

Rhythmical auditory stimulation gait training group

干预措施: Rhythmical auditory stimulation gait training (RAS) (Behavioral)

MPT group

Experimental

Muscle power training group

干预措施: Muscle power training (MPT) (Behavioral)

Control group

Other

Usual care group

干预措施: Controls (Other)

结局指标

主要结局

Changes in spatiotemporal gait parameter - stride length (cm)

时间窗: 9 months

Changes in spatiotemporal gait parameter - cadence (steps/min)

时间窗: 9 months

Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)

时间窗: 9 months

Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)

时间窗: 9 months

Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)

时间窗: 9 months

Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)

时间窗: 9 months

Changes in spatiotemporal gait parameter - gait velocity (m/s)

时间窗: 9 months

次要结局

  • Changes in kinematic gait parameters(9 months)
  • Changes in leg muscle peak electromyographic values(9 months)
  • Changes in leg muscle maximum strength(9 months)
  • Changes in leg muscle force production time(9 months)
  • Changes in self-reported falls(9 months)

研究者

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

Shirley S.M. Fong

Principal Investigator

The University of Hong Kong

研究点 (1)

Loading locations...

相似试验