跳至主要内容
临床试验/NCT04176159
NCT04176159进行中(未招募)不适用

Experimental Research Study About the Effectiveness of a Physiotherapy Program Based on Motor Imagery and Task-oriented Training in Children With Developmental Coordination Disorder

David Moreno Naya2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2019年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
99
试验地点
2
主要终点
Changes in children´s motor competence

研究概览

简要总结

Experimental study based on the effectiveness of motor imagery and task-oriented training over the motor competence in children with Developmental Coordination Disorder (DCD).

A bilateral hypothesis is assumed for the clinical trial:

  • Null hypothesis: physiotherapeutic intervention programs through motor imagery combined with task-oriented training DO NOT modify the parameters of motor competence, anxiety and participation in children susceptible to observation of DCD.
  • Alternative hypothesis: physiotherapeutic intervention programs through motor imagery combined with task-oriented training MODIFY the parameters of motor competence, anxiety and participation in children susceptible to observation of DCD.

详细描述

An experimental and prospective study that will measure changes in motor competence and anxiety levels of school-age children (6 to 12 years old) with suspected presence of Development Coordination Disorder (DCD), before and after participating in a program of physiotherapy based on the combination of motor imagery and task-oriented work developed in their educational center.

A bilateral hypothesis is assumed for the clinical trial:

  • Null hypothesis: physiotherapeutic intervention programs through motor imagery combined with task-oriented training DO NOT modify the parameters of motor competence, anxiety and participation in children susceptible to observation of DCD.
  • Alternative hypothesis: physiotherapeutic intervention through motor imagery combined with task-oriented training DO modify the parameters of motor competence, anxiety and participation in children susceptible to observation of DCD.

SAMPLE STUDY: the target group will be composed for children of school age, aged between 6 and 12 years (Primary Education), susceptible to diagnosis of Developmental Coordination Disorder.

The recruitment of subjects will be carried out in Primary Education centers framed in the city of A Coruña and its metropolitan area. For this, a first phase of selection or screening will be carried out through the application of a specific questionnaire for the detection of DCD by parents and teachers, and a subsequent analysis of the susceptible subjects through the Movement Assessment Battery for Children, in their second version (MABC-2). The final sample will be composed of those individuals who show a percentile lower than 15 in this battery.

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of school age, aged between 6 and 12, susceptible to the presence of Developmental Coordination Disorder. The sample of participants in the control group will be composed for children with identical characteristics, who will carry out the development of their usual school activity and who will receive the same treatment once the results are obtained.

排除标准

  • diagnosed neurological pathology not associated with DCD or any physical or psychological condition that prevents the completion of the proposed intervention.
  • absence of authorization of informed consent by a father, mother or legal tutor.

研究组 & 干预措施

Motor imagery and task-oriented training group

Experimental

Two modules. A first module of motor imagery. A second module of task-oriented training and the incorporation of collective activities.

干预措施: MOTOR IMAGERY AND TASK-ORIENTED TRAINING (Other)

Usual school routines group

No Intervention

Children continue with the usual school routine. Once the study is completed and the corresponding measurements have been made, the subjects included in this group will be subjected to the same program detailed in the intervention, to not deprive them of their benefits.

结局指标

主要结局

Changes in children´s motor competence

时间窗: It´s estimated an application time of 20 minutes per evaluation. One application immediately before the intervention and another application immediately after the intervention.

Changes are measured with the Movement Assessment Battery for Children - Second Version (MABC-2). The final result is composed of scalar scores (from 1 to 19 points), associated with percentiles. Higher scores refer better result. The MABC-2 is a standardized test of motor competence assessment aimed at the description and diagnosis of motor problems in children respect to the corresponding development to their age group. The test is presented divided into three age ranges (4-6 years; 7-10 years; 11-16 years). In each range are applied a total of 8 items grouped into three dimensions: manual dexterity, aiming and trapping, and balance (static and dynamic).

次要结局

  • Changes in anxiety levels(It´s estimated an application time of 30 minutes per evaluation. One application immediately before the intervention and another application immediately after the intervention.)
  • Satisfaction level: Ad Hoc questionnaire used a Likert scale(A single application of 15 minutes at the eighth week.)

研究者

发起方
David Moreno Naya
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Moreno Naya

Principal Investigator

Universidade da Coruña

研究点 (2)

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