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Developmental Coordination DisorderNCT04176159

Effectiveness of Motor Imagery and Task-oriented Training in Children With Developmental Coordination Disorder

A study testing MOTOR IMAGERY AND TASK-ORIENTED TRAINING in people with Developmental Coordination Disorder, run by David Moreno Naya at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Developmental Coordination Disorder
What is being tested?
MOTOR IMAGERY AND TASK-ORIENTED TRAINING
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteSpain
Study dates
16 Dec 2019to 28 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • CEIP Vales Villamarín

    Betanzos, A Coruña, 15319

Other trials in Spain

About this study

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

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.
Read the 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:
  3. MOTOR COMPETITION: Movement Assessment Battery for Children-Version 2 (MABC-2).
  4. ANXIETY LEVEL: Spence Children Anxiety Scale.
  5. 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.

Being tested
MOTOR IMAGERY AND TASK-ORIENTED TRAINING
Keywords
Developmental Coordination Disorder, Task-Oriented Training, Motor Imagery, Physical Therapy
Medical subject headings
Motor Skills Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOTOR IMAGERY AND TASK-ORIENTED TRAININGOther

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

    The investigators will apply 20 sessions of 40 minutes.

Study groups in NCT04176159
Study groupRoleWhat they receive
Motor imagery and task-oriented training groupExperimentalTwo modules. A first module of motor imagery. A second module of task-oriented training and the incorporation of collective activities.
Receives: Other: MOTOR IMAGERY AND TASK-ORIENTED TRAINING
Usual school routines groupNo interventionChildren 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in children´s motor competence

    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).

    Measured: 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 (2)
  1. Changes in anxiety levels

    Changes are measures with Spence Children´s Anxiety Scale. It consists of 44 items divided into 8 domains: generalized anxiety, panic, separation anxiety, obsessive compulsive disorder, social phobia, fear of physical damage, agoraphobia and compensation of biases.

    Scores range from 0 to 132 points. A higher score identifies greater anxiety.

    Measured: It´s estimated an application time of 30 minutes per evaluation. One application immediately before the intervention and another application immediately after the intervention.

  2. Satisfaction level: Ad Hoc questionnaire used a Likert scale

    Numerical variables that will be extracted through an Ad Hoc questionnaire used a Likert scale. There are no validated satisfaction scales in this area of research, so it has been decided to develop a scale of its own.

    Scores range from 5 to 35 points. A higher score identifies greater satisfaction.

    Measured: A single application of 15 minutes at the eighth week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2019
  2. Study start16 Dec 2019
  3. Primary completion20 Dec 2019
  4. Study completion28 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04176159
Sponsor's protocol ID
PT29394474
Status last verified
Jun 2025
First submitted
5 Nov 2019
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study protocol will be published. This protocol is part of a doctoral thesis project linked to the University of A Coruña. The results will be available in the University Repository for free. Subsequently, it will be published in scientific journals and will be available in Research Gate and other similar platforms.

Publications

  • Biotteau M, Danna J, Baudou E, Puyjarinet F, Velay JL, Albaret JM, Chaix Y. Developmental coordination disorder and dysgraphia: signs and symptoms, diagnosis, and rehabilitation. Neuropsychiatr Dis Treat. 2019 Jul 8;15:1873-1885. doi: 10.2147/NDT.S120514. eCollection 2019.

    PubMed 31371960
  • Gheysen F, Van Waelvelde H, Fias W. Impaired visuo-motor sequence learning in Developmental Coordination Disorder. Res Dev Disabil. 2011 Mar-Apr;32(2):749-56. doi: 10.1016/j.ridd.2010.11.005. Epub 2010 Dec 4.

    PubMed 21131177
  • McHale K, Cermak SA. Fine motor activities in elementary school: preliminary findings and provisional implications for children with fine motor problems. Am J Occup Ther. 1992 Oct;46(10):898-903. doi: 10.5014/ajot.46.10.898.

    PubMed 1463061
  • Wilson PH, McKenzie BE. Information processing deficits associated with developmental coordination disorder: a meta-analysis of research findings. J Child Psychol Psychiatry. 1998 Sep;39(6):829-40.

    PubMed 9758192
  • Blank R, Barnett AL, Cairney J, Green D, Kirby A, Polatajko H, Rosenblum S, Smits-Engelsman B, Sugden D, Wilson P, Vincon S. International clinical practice recommendations on the definition, diagnosis, assessment, intervention, and psychosocial aspects of developmental coordination disorder. Dev Med Child Neurol. 2019 Mar;61(3):242-285. doi: 10.1111/dmcn.14132. Epub 2019 Jan 22.

    PubMed 30671947
  • Blank R. European Academy of Childhood Disability (EACD): Recommendations on the definition, diagnosis and intervention of developmental coordination disorder (pocket version). German-Swiss interdisciplinary clinical practice guideline S3-standard according to the Association of the Scientific Medical Societies in Germany. Pocket version. Definition, diagnosis, assessment, and intervention of developmental coordination disorder (DCD). Dev Med Child Neurol. 2012 Nov;54(11):e1-7. doi: 10.1111/j.1469-8749.2011.04175.x. Epub 2012 Feb 9. No abstract available.

    PubMed 22320659
  • Pratt ML, Hill EL. Anxiety profiles in children with and without developmental coordination disorder. Res Dev Disabil. 2011 Jul-Aug;32(4):1253-9. doi: 10.1016/j.ridd.2011.02.006. Epub 2011 Mar 5.

    PubMed 21377831
  • Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.

    PubMed 23106530
  • Wilson PH, Ruddock S, Smits-Engelsman B, Polatajko H, Blank R. Understanding performance deficits in developmental coordination disorder: a meta-analysis of recent research. Dev Med Child Neurol. 2013 Mar;55(3):217-28. doi: 10.1111/j.1469-8749.2012.04436.x. Epub 2012 Oct 29.

    PubMed 23106668
  • Preston N, Magallon S, Hill LJ, Andrews E, Ahern SM, Mon-Williams M. A systematic review of high quality randomized controlled trials investigating motor skill programmes for children with developmental coordination disorder. Clin Rehabil. 2017 Jul;31(7):857-870. doi: 10.1177/0269215516661014. Epub 2016 Aug 1.

    PubMed 27481937

Questions about this trial

What is this clinical trial studying?

A study testing MOTOR IMAGERY AND TASK-ORIENTED TRAINING in people with Developmental Coordination Disorder, run by David Moreno Naya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in children´s motor competence (time frame: It´s estimated an application time of 20 minutes per evaluation. One application immediately before the intervention and another application immediately after the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04176159, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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