Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04176159
Study type Interventional
Source Universidade da Coruña
Contact
Status Active, not recruiting
Phase N/A
Start date December 16, 2019
Completion date January 28, 2025

See also
  Status Clinical Trial Phase
Completed NCT05092893 - Social Skills in Children With Developmental Coordination Disorder (DCD)
Recruiting NCT04490187 - tDCS and Motor Learning in Children With DCD N/A
Completed NCT01313325 - Hippotherapy to Improve the Balance of Children With Movement Disorders N/A
Completed NCT04126395 - An Explorative RVA of the Motor Development of Children With DCD <2y
Completed NCT03690843 - Development of Children With DCD Before the Age of Six
Recruiting NCT06012903 - Lower Urinary Tract Symptoms and School Functioning in Children
Active, not recruiting NCT06311110 - Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD
Active, not recruiting NCT03150784 - Rhythmic Motor Learning in Children With Developmental Coordination Disorders N/A
Not yet recruiting NCT06006767 - Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children
Recruiting NCT04122820 - Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD). N/A
Not yet recruiting NCT05079490 - Motor Intervention for Preschooler With Motor Coordination Deficits N/A
Completed NCT00766051 - A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU. N/A
Recruiting NCT06183411 - Theory of Mind in Children With DCD N/A
Completed NCT03595826 - Co Morbid Attention Deficit and Hyperactivity Disorder(ADHD) and Developmental Co Ordination Disorder (DCD) N/A
Completed NCT03112746 - Efficacy of the CO-OP Approach With Brazilian Children With Developmental Coordination Disorder N/A
Active, not recruiting NCT02393404 - Functional Movement-power Training for Children With Developmental Coordination Disorder: A Randomised Controlled Trial N/A
Completed NCT06015347 - The Relationship Between Developmental Level in Infancy and Preschool Motor Performance in Risky Infants
Not yet recruiting NCT03838614 - Gait and Muscle Power Training for Children With Developmental Coordination Disorder N/A
Completed NCT03453983 - Does tDCS Improve Motor Learning in Children With DCD? N/A
Recruiting NCT06161168 - Bootle Blast: Understanding the Family Experience N/A