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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03699800
Other study ID # 06102018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date December 31, 2019

Study information

Verified date March 2020
Source University of Évora
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

According to estimates (1), 30% to 60% of the school day is spent performing tasks involving handwriting. It is also in this period that the formal learning of handwriting begins (2). However, not all children are able to develop proficient handwriting (3-4).

According to Alhusaini, Melam and Buragadda (5) 12% to 30% of children present difficulties in handwriting, with negative consequences for school success (6).

Children who fail to develop proficient handwriting are entitled to "poor writers" or "dysgraphics" (7-8).

Dysgraphia refers to a "disturbance or difficulty in the production of written language related to the mechanics of writing" (9). Ajuriaguerra (8) defines it as a writing whose quality is deficient, without any neurological or intellectual deficit explaining it. Generally, handwriting is less legible and organized, contains more erasures and corrections, and exhibits a slower speed (9).

In addition, this is one of the main reasons for referral and consultation in psychomotricity in school-age (10), for this reason it is fundamental to bet on the prevention of them.

The need for prevention and early intervention is indisputable (11). Several studies indicate that both the benefits of late intervention are well-known, because the time is often difficult to correct handwriting difficulties (12-13).

Most of the existing studies focus on remediation of handwriting (14). There is evidence of its efficacy in handwriting improvement, depending on its duration, frequency and method of treatment (5, 7, 15).

There are few studies dedicated to the prevention of handwriting difficulties (14). In addition, to my knowledge, there is no study whose intervention is based on a psychomotor approach. Based on this, a graphomotor intervention program with a psychomotor approach was developed, by Matias and Vieira (16), who will apply in this study to children in the second grade of elementary school.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 7 Years
Eligibility Inclusion Criteria:

- Children in the second grade (aged 7 years old);

- Participation agreement;

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Graphomotor intervention program
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.

Locations

Country Name City State
Portugal Helena Isabel Falcão Coradinho Évora

Sponsors (1)

Lead Sponsor Collaborator
University of Évora

Country where clinical trial is conducted

Portugal, 

References & Publications (16)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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

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

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. — View Citation

Hoy MM, Egan MY, Feder KP. A systematic review of interventions to improve handwriting. Can J Occup Ther. 2011 Feb;78(1):13-25. Review. — View Citation

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

Matias A, Vieira C. Programa de intervenção grafomotora. [In press].

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. — View Citation

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

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.

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.

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

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

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Sociodemographic characteristics The Sociodemographic Questionnaire collects data on the identification of the child, the parents, the sociodemographic context and the socioeconomic status of the family based on the Graffar Social Classification Scale Adapted 0 months
Secondary Change from Baseline, between and within groups comparison, in Manual Preference Outcome Measure - Manual Preference Questionnaire to assess manual preference 0, 4, 10 months
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