Clinical trial NCT04176159: Effectiveness of Motor Imagery and Task-oriented Training in Children With Developmental Coordination Disorder
Official title: Experimental Research Study About the Effectiveness of a Physiotherapy Program Based on Motor Imagery and Task-oriented Training in Children With Developmental Coordination Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Developmental Coordination Disorder
Keywords: Developmental Coordination Disorder
Task-Oriented Training
Motor Imagery
Physical Therapy
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 99
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects will be randomized into 2 groups: an intervention group, which will participate in a program based on the combination of motor imagery and work oriented to the motor task; and a control group, which will carry out their usual school routine.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

After obtaining informed consent, the subjects will be distributed randomly in 2 groups: an intervention group, with a program based on the combination of motor imagery and motor task oriented training; and a control group, which will carry out their usual school routine. In turn, the groups will be subdivided according to the age group in which the participants are (6-9 years and 10-12 years).

Subsequently, the data of each research subject will be codified.

SAMPLE SIZE:

After the application of the corresponding calculations to the sample size, collecting a 95% confidence interval, a statistical power of 80%, and a loss percentage of 10% of the cases, a minimum sample size of 36 individuals is obtained per each group.

TYPE OF EXPERIMENT AND SELECTED DESIGN: Analytical, longitudinal and prospective research study. Randomized controlled clinical trial with a comparison between an intervention group and a control group.

DATA COLLECT:

1. Personal data: anonymized and coded according to current regulations (RGPD 2016/679 - Europe)
2. Clinical research data:

A. MOTOR COMPETITION: Movement Assessment Battery for Children-Version 2 (MABC-2).

B. ANXIETY LEVEL: Spence Children Anxiety Scale.

C. SATISFACTION, ADHERENCE AND PARTICIPATION: Likert scale.

The data regarding motor competence and anxiety will be taken at the beginning and at the end of the program, as well as in a follow-up measurement that will be carried out 4 weeks later. The satisfaction and adherence scales will be passed only at the end of the study.

All these data will be entered into a specific computer program for later statistical management.

INTERVENTION:

A total of 20 sessions divided into two differential modules will be held. A first module will include activities of activation and relaxation of the body, prediction and sequencing of movement and motor imagery. The second module, of work oriented to the motor task, will be divided into a first phase of analytical work of the altered movement components (visual coordination, balance, muscular strength, fine motor skills ...), a second phase of integration into specific tasks and, at the end, the inclusion of the free (and supervised) sport practice.

STATISTICAL ANALYSIS STRATEGY:

A descriptive study of all the variables will be carried out. Quantitative variables will be expressed as a mean together with their standard deviation value.

Subsequently, randomness, normality and homogeneity tests of variances will be carried out. Depending on the results, the comparison of means will be carried out by parametric or non-parametric means.

All p values \<0.05 will be considered statistically significant. The SPSS 23.0 program will be used to proceed with this analysis.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in children´s motor competence
timeFrame: It´s estimated an application time of 20 minutes per evaluation. One application immediately before the intervention and another application immediately after the intervention.
Secondary outcomes:
measure: Changes in anxiety levels
timeFrame: It´s estimated an application time of 30 minutes per evaluation. One application immediately before the intervention and another application immediately after the intervention.
measure: Satisfaction level: Ad Hoc questionnaire used a Likert scale
timeFrame: A single application of 15 minutes at the eighth week.
Other outcomes:
Locations:
city: Betanzos
country: Spain
facility: CEIP Vales Villamarín
state: A Coruña
Study officials:
name: David Moreno
role: PRINCIPAL_INVESTIGATOR
References:
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