NCT03699787

Brief Summary

12-30% of children present handwriting difficulties, which has negative repercussions on their school career. For this reason, it is fundamental to bet on their prevention. The aim of present study is to examine the effects of a graphomotor intervention program on graphomotor competences in children in the last year of preschool education. This experimental study is a randomized controlled trial. The program will run for 8 weeks (2 sessions/week of 30 minutes), followed by 6 months of follow-up without intervention. Participants will be assessed 1) at baseline, 2) at the end of the program, and 3) after the follow-up. Participants will be randomly allocated to two groups: experimental group (graphomotor intervention program) and control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

October 5, 2018

Last Update Submit

March 26, 2020

Conditions

Keywords

Graphomotor intervention programPreschool childrenGraphomotor competencesPrevention

Outcome Measures

Primary Outcomes (4)

  • Change from Baseline, between and within groups comparison, in Manual Preference

    Outcome Measure - Manual Preference Questionnaire to assess manual preference

    0, 4, 10 months

  • Change from Baseline, between and within groups comparison, in Motor Performance

    Outcome Measure - Movement Assessment Battery for Children - Second Edition to assess manual dexterity, aiming and catching and balance

    0, 4, 10 months

  • Change from Baseline, between and within groups comparison, in Visual-Motor Integration

    Outcome Measure - Beery-Buktenica Developmental Test of Visual-Motor Integration, Sixth Edition to assess visual-motor integration, visual perception and motor coordination

    0, 4, 10 months

  • Change from Baseline, between and within groups comparison, in Computerized Handwriting Process Measures

    Outcome Measure - The MovAlyzeR to assess spatial, temporal and kinematic variables of handwriting

    0, 4, 10 months

Secondary Outcomes (1)

  • Sociodemographic characteristics

    0 months

Study Arms (2)

Graphomotor intervention program

EXPERIMENTAL

The experimental group (EG) intervention comprises a graphomotor intervention program according to a psychomotor approach. The program integrates two group sessions (6-8 children)/week of 30 minutes for 8 weeks (16 sessions).

Other: Graphomotor intervention program

Control Group

NO INTERVENTION

The control group (CG) participants will maintain their normal classroom activities. After the study, control group participants will be offered the opportunity to integrate a similar graphomotor intervention program.

Interventions

The graphomotor intervention program aims to promote the development and reinforcement, different skills involved in the learning process of handwriting and has a preventive character. It follows a bodily, playful, multisensory, exploratory (sensory integration) and neuromotor task training approach and focuses on the following intervention domains: segmental awareness, passive relaxation, trunk-limb dissociation, interdigital coordination, attention, planning, spatial organization/orientation and perception.

Graphomotor intervention program

Eligibility Criteria

Age5 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children in the last year of preschool education (aged 5 years old);
  • Participation agreement.

You may not qualify if:

  • Diagnosed or suspected of neurological disabilities (e.g., cerebral palsy, epilepsy), psychiatric and/or behavioural disorders;
  • Presence of uncorrected vision and hearing problems;
  • Referenced by Special Education/National Service of Early Intervention in Childhood;
  • Native language is not Portuguese;
  • Children with direct intervention in graphomotor skills or who had a similar intervention to that proposed less than 1 year ago;
  • Participation in the intervention program of less than 80%;
  • Children undergoing drug therapy (e.g., antihistamines) that interfere with the study variables;
  • Do not wish to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helena Isabel Falcão Coradinho

Evora, 7040, Portugal

Location

Related Publications (19)

  • Alhusaini AA, Melam GR, Buragadda S. Short-term sensorimotor-based intervention for handwriting performance in elementary school children. Pediatr Int. 2016 Nov;58(11):1118-1123. doi: 10.1111/ped.13004. Epub 2016 Jul 7.

    PMID: 27085075BACKGROUND
  • Soppelsa R, Albaret JM. Caractéristiques de la dysgraphie ou du trouble de l'apprentissage de la graphomotricité (TAG) au collège. A.N.A.E. 2014 Fev; 128:1-6. Available at: http://www.psychomot.ups-tlse.fr/Soppelsa-Albaret2014.pdf

    BACKGROUND
  • Lachaux-Parker C. Troubles de l'écriture et psychomotricité. Revue francophone d'orthoptie. 2012; 5:143-7. doi: 10.1016/j.rfo.2013.02.002

    BACKGROUND
  • Borghese NA, Palmiotto C, Essenziale J, Mainetti R, Granocchio E, Molteni B et al. Assessment of Exergames as Treatment and Prevention of Dysgraphia. In: Ibáñez J, González-Vargas J, Azorín J, Akay M, Pons J. Converging Clinical and Engineering Research on Neurorehabilitation II. Cham: Springer; 2017. p. 431-6.

    BACKGROUND
  • Graham S, Harris KR. Preventing Writing Difficulties: Providing Additional Handwriting and Spelling Instruction to At-Risk Children in First Grade. Teaching Exceptional Children. 2006 May/Jun; 38(5):64-66. doi: 10.1177/004005990603800509

    BACKGROUND
  • Graham S, Harris KR, & Fink B. Is handwriting causally related to learning to write? Treatment of handwriting problems in beginning writers. Journal of Educational Psychology. 2000; 92(4):620-33. doi: 10.1037/0022-0663.92.4.620

    BACKGROUND
  • Feder KP, Majnemer A. Handwriting development, competency, and intervention. Dev Med Child Neurol. 2007 Apr;49(4):312-7. doi: 10.1111/j.1469-8749.2007.00312.x.

    PMID: 17376144BACKGROUND
  • Morin MF, Bara F, Alamargot D. Apprentissage de la graphomotricité à l'école: Quelles acquisitions? Quelles pratiques? Quels outils?. Scientia Paedagogica Experimentalis. 2017 Jul; 54(1-2):47-84. Available at: https://researchgate.net/publication/204380193_Apprentissage_de_la_graphomotricite_a_l'école_Quelles_acquisitions_Quelles_pratiques_Quels_outils

    BACKGROUND
  • Zeziger P, Deonna T, Mayor C. L'acquisition de l'écriture. Enfance. 2000; 3:295-304. Available at: http://www.persee.fr/doc/enfan_0013-7545_2000_num_53_3_3186

    BACKGROUND
  • Puranik CS, Lonigan CJ. From Scribbles to Scrabble: Preschool Children's Developing Knowledge of Written Language. Read Writ. 2011 May;24(5):567-589. doi: 10.1007/s11145-009-9220-8.

    PMID: 22448101BACKGROUND
  • Marr D, Cermak S, Cohn ES, Henderson A. Fine motor activities in Head Start and kindergarten classrooms. Am J Occup Ther. 2003 Sep-Oct;57(5):550-7. doi: 10.5014/ajot.57.5.550.

    PMID: 14527117BACKGROUND
  • Lifshitz N, Har-Zvi S. A Comparison Between Students Who Receive and Who Do Not Receive a Writing Readiness Interventions on Handwriting Quality, Speed and Positive Reactions. Early Childhood Educ J. 2014 Jan; 43(1):47-55. doi: 10.1007/s10643-013-0629-y

    BACKGROUND
  • Dinehart L. Handwriting in early childhood education: Current research and future implications. Journal of Early Childhood Literacy. 2015 Mar; 15(1):97-118. doi: 10.1177/1468798414522825

    BACKGROUND
  • Donica D, Goins A, Wagner L. Effectiveness of Handwriting Readiness Programs on Postural Control, Hand Control, and Letter and Number Formation in Head Start Classrooms. Journal of Occupational Therapy, Schools, & Early Intervention. 2013 Dec; 6(2):81-93. doi: 10.1080/19411243.2013.810938

    BACKGROUND
  • van Hartingsveldt MJ, De Groot IJ, Aarts PB, Nijhuis-Van Der Sanden MW. Standardized tests of handwriting readiness: a systematic review of the literature. Dev Med Child Neurol. 2011 Jun;53(6):506-15. doi: 10.1111/j.1469-8749.2010.03895.x. Epub 2011 Feb 11.

    PMID: 21309763BACKGROUND
  • Beery KE. The Developmental Test of Visual/Motor Integration. CJeveland: Modern Curriculum Press; 1982.

    BACKGROUND
  • Spanaki I, Venetsanou F, Evaggelinou C, Skordilis E. Graphomotor skills of Greek kindergarten and elementar school children: effect of a fine motor intervention program. Comprehensive Psychology. 2014 Jan; 2(3):1-10. doi: 10.2466/01.09.IT.3.2

    BACKGROUND
  • Lust CA, Donica DK. Effectiveness of a handwriting readiness program in head start: a two-group controlled trial. Am J Occup Ther. 2011 Sep-Oct;65(5):560-8. doi: 10.5014/ajot.2011.000612.

    PMID: 22026324BACKGROUND
  • Matias A, Vieira C. Programa de intervenção grafomotora. [In press].

    BACKGROUND

MeSH Terms

Conditions

Agraphia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Helena IF Coradinho, MSc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

October 15, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations