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临床试验/NCT06544317
NCT06544317Enrolling By Invitation不适用

Motor Intervention for Children With Developmental Coordination Disorder

Zhiguang Ji1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
1
主要终点
Reaction time (RT) of modified Stroop task

研究概览

简要总结

This study focuses on the effects of physical activity in schools on the cognitive function and physical fitness of children with and without developmental coordination disorder (DCD). Methods: 58 children with DCD participated in an 8-week exercise program. Children's standing broad jump (SBJ), 50m dash, 50m*8 shuttle run, mental rotation and executive functions were assessed before and after training. A mixed-design analysis of variance (ANOVA) was conducted separately for each performance variable.

详细描述

Potential children were identified from elementary schools in three districts of Shanghai. The study protocol was approved by the Ethics Committee of Shanghai Uni-versity of Medicine and Health Sciences. In order to select the research sample, recruitment letters were sent to the parents of all children; these letters detailed the purpose, significance and research process of the study, and a consent form was attached. If parents were willing to participate in the study, they were asked to sign the consent form and scan the QR code to fill in the questionnaire, including DCDQ, the Attention Deficit/Hyperactivity Disorder (ADHD) Rating Scale-VI and other personal information. All questionnaire contents were only accessible to research team members, and the researcher's name and telephone number were provided in case parents had questions. A total of 2,761 children and their parents volunteered to participate in this study. Children were screed using the Developmental Coordination Disorder Questionnaire (DCDQ) . Teachers selected those children with probable DCD but without any intellectual or cognitive impairment. These children were then tested using the Movement Assessment Battery for Children, 2nd edition. Finally, 116 pDCD children were randomly divided into a training group (TG, mean age 10.67 ± 1.25 years, 50 boys and 8 girls) and a control group (CG, mean age 10.27 ± 1.04 years, 48 boys and 10 girls) and gender matched typically developing (TD, mean age 10.35 ± 1.87 years; 48 boys and 12 girls) controls were included in the study. TG and TD will receive an additional 8 weeks of physical training intervention, while CG will not participate in the physical training intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • DCDQ scores as follows: (8-9 years: < 56 points; 10-12 years: < 58 points)
  • one subitem of the MABC-2 rank below 15%
  • age 9 to 11 years old (elementary school age)

排除标准

  • Children with other mental illness who are unable to exercise

结局指标

主要结局

Reaction time (RT) of modified Stroop task

时间窗: 8 weeks

The computerized modified Stroop task includes the following two conditions: a naming (non-execution) and execution condition. In the naming condition, the screen will display a colored "XXX" and the children need to press the key corresponding to the color. In the execution condition, the stimulus will show a distracting-colored word, similar to the classic Stroop, showing Chinese characters in either blue or red; in this test, the children need to press the key corresponding to the color of the word, rather than the meaning of the Chinese character. When the color of the word is consistent with its meaning, the condition is congruent; when the color of the word is inconsistent with its meaning, it is the condition is incongruent.

Standing broad jump

时间窗: 8 weeks

The SBJ test, which is completed on a flat surface, is used to evaluate the explosive strength of the lower limbs.

Safety and Tolerability

时间窗: 8 weeks

There were no safety and adverse events

Reaction time (RT) of mental rotation tasks

时间窗: 8 weeks

The experiment involved simultaneously presenting children with two pictures of "giraffes". The image on the left was fixed as the target, and the image on the right showed angle or mirror differences. The angular disparities were 0°, 60°, 120° or 180°. Through rotation, the children were asked to determine, as quickly and accurately as possible, whether the two images were identical.

50m*8 shuttle run

时间窗: 8 weeks

children are required to run back and forth between two points as quickly as possible.

50m sprint

时间窗: 8 weeks

The 50m sprint test requires students to start in a standing position and complete a 50m sprint with all their strength. The test is conducted twice, and the fastest result is recorded.

次要结局

  • Height(8 weeks)
  • Weight(8 weeks)

研究者

发起方
Zhiguang Ji
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhiguang Ji

doctor

Shanghai University of Medicine and Health Sciences

研究点 (1)

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