Ignite Creation Date:
2024-05-06 @ 1:58 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04176159
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2019-11-05
Brief Title:
Effectiveness of Motor Imagery and Task-oriented Training in Children With Developmental Coordination Disorder
Sponsor:
David Moreno Naya
Organization:
Universidade da Coruña
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 2016679 - 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 005 will be considered statistically significant The SPSS 230 program will be used to proceed with this analysis
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 2016679 - 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 005 will be considered statistically significant The SPSS 230 program will be used to proceed with this analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None