NCT04176159

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Dec 2019Aug 2026

First Submitted

Initial submission to the registry

November 5, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

December 16, 2019

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Expected
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

4 days

First QC Date

November 5, 2019

Last Update Submit

June 12, 2025

Conditions

Keywords

Developmental Coordination DisorderTask-Oriented TrainingMotor ImageryPhysical Therapy

Outcome Measures

Primary Outcomes (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).

    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)

  • 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.

Study Arms (2)

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.

Other: MOTOR IMAGERY AND TASK-ORIENTED TRAINING

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.

Interventions

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.

Motor imagery and task-oriented training group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEIP Vales Villamarín

Betanzos, A Coruña, 15319, Spain

Location

Related Publications (10)

  • 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.

    PMID: 31371960BACKGROUND
  • 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.

    PMID: 21131177BACKGROUND
  • 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.

    PMID: 1463061BACKGROUND
  • 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.

    PMID: 9758192BACKGROUND
  • 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.

    PMID: 30671947BACKGROUND
  • 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.

    PMID: 22320659BACKGROUND
  • 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.

    PMID: 21377831BACKGROUND
  • 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.

    PMID: 23106530BACKGROUND
  • 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.

    PMID: 23106668BACKGROUND
  • 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.

    PMID: 27481937BACKGROUND

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • David Moreno

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 25, 2019

Study Start

December 16, 2019

Primary Completion

December 20, 2019

Study Completion (Estimated)

August 28, 2026

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After the deposit and defense of the Doctoral Thesis, the data will be available in the Repository of the University of A Coruña for free.
Access Criteria
Initially, the data of the study will be available in the Repository of the University of A Coruña for all those researchers who are interested in the subject, in order to contrast ideas and be useful for future research.

Locations