NCT03699800

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 quality and speed of handwriting in second-grade children. 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
47

participants targeted

Target at P25-P50 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 programSecond grade childrenPrevention and early identificationProcess and product of handwritingQuality and speed of handwriting

Outcome Measures

Primary Outcomes (3)

  • 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 handwriting performance

    Outcome Measure - The Concise Assessment Scale for Children's Handwriting (BHK) to assess quality and speed of handwriting

    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 (2)

  • Sociodemographic characteristics

    0 months

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

    0, 4, 10 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

Age7 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children in the second grade (aged 7 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;
  • Presence of one or more school retentions;
  • 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 (16)

  • Engel-Yeger B, Rosenblum S. The effects of protracted graphomotor tasks on tripod pinch strength and handwriting performance in children with dysgraphia. Disabil Rehabil. 2010;32(21):1749-57. doi: 10.3109/09638281003734375.

    PMID: 20373859BACKGROUND
  • 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
  • Denton PL, Cope S, Moser C. The effects of sensorimotor-based intervention versus therapeutic practice on improving handwriting performance in 6- to 11-year-old children. Am J Occup Ther. 2006 Jan-Feb;60(1):16-27. doi: 10.5014/ajot.60.1.16.

    PMID: 16541981BACKGROUND
  • Schneck C, Amundson S. Prewriting and Handwriting Skills. In Case-Smith J., O'Brien J, cords. Occupational Therapy for Children. Missouri: Elsevier; 2010. p. 555-82.

    BACKGROUND
  • 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
  • Rosenblum S, Aloni T, Josman N. Relationships between handwriting performance and organizational abilities among children with and without dysgraphia: a preliminary study. Res Dev Disabil. 2010 Mar-Apr;31(2):502-9. doi: 10.1016/j.ridd.2009.10.016. Epub 2009 Nov 27.

    PMID: 19945252BACKGROUND
  • Soppelsa R, Abizeid C, Chéron A, Laurent A, Danna J, Albaret, JM. Dysgraphies et rééducation psychomotrice: Données actuelles. In: Albaret JM, Matta Abizeid C, Soppelsa R. Les Entretiens de Bichat. Publisher: Toulouse - Europa Digital & Publishing, Editors; 2016. p 5-11.

    BACKGROUND
  • Rosenblum S, Dror G. Identifying Developmental Dysgraphia Characteristics Utilizing Handwriting Classification Methods. IEEE Transactions on Human-Machine Systems. 2016 Oct; 47(2): 293-8. doi: 10.1109/THMS.2016.2628799

    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
  • Howe TH, Roston KL, Sheu CF, Hinojosa J. Assessing handwriting intervention effectiveness in elementary school students: a two-group controlled study. Am J Occup Ther. 2013 Jan-Feb;67(1):19-26. doi: 10.5014/ajot.2013.005470.

    PMID: 23245779BACKGROUND
  • Hoy MM, Egan MY, Feder KP. A systematic review of interventions to improve handwriting. Can J Occup Ther. 2011 Feb;78(1):13-25. doi: 10.2182/cjot.2011.78.1.3.

    PMID: 21395194BACKGROUND
  • 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