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Graphomotor Intervention Program for Handwriting Difficulties Prevention in School-Age

Primary Purpose

Typical Development, Risk of Dysgraphia, Dysgraphia

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Graphomotor intervention program
Sponsored by
University of Évora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Typical Development focused on measuring Graphomotor intervention program, Second grade children, Prevention and early identification, Process and product of handwriting, Quality and speed of handwriting

Eligibility Criteria

7 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Helena Isabel Falcão Coradinho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Graphomotor intervention program

Control Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
Change from Baseline, between and within groups comparison, in Manual Preference
Outcome Measure - Manual Preference Questionnaire to assess manual preference

Full Information

First Posted
October 5, 2018
Last Updated
March 26, 2020
Sponsor
University of Évora
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1. Study Identification

Unique Protocol Identification Number
NCT03699800
Brief Title
Graphomotor Intervention Program for Handwriting Difficulties Prevention in School-Age
Official Title
The Effects of a Graphomotor Intervention Program According to a Psychomotor Approach on Quality and Speed of Handwriting in School-Age Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Évora

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typical Development, Risk of Dysgraphia, Dysgraphia
Keywords
Graphomotor intervention program, Second grade children, Prevention and early identification, Process and product of handwriting, Quality and speed of handwriting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Graphomotor intervention program
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Graphomotor intervention program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline, between and within groups comparison, in Motor Performance
Description
Outcome Measure - Movement Assessment Battery for Children - Second Edition to assess manual dexterity, aiming and catching and balance
Time Frame
0, 4, 10 months
Title
Change from Baseline, between and within groups comparison, in handwriting performance
Description
Outcome Measure - The Concise Assessment Scale for Children's Handwriting (BHK) to assess quality and speed of handwriting
Time Frame
0, 4, 10 months
Title
Change from Baseline, between and within groups comparison, in Computerized Handwriting Process Measures
Description
Outcome Measure - The MovAlyzeR to assess spatial, temporal and kinematic variables of handwriting
Time Frame
0, 4, 10 months
Secondary Outcome Measure Information:
Title
Sociodemographic characteristics
Description
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
Time Frame
0 months
Title
Change from Baseline, between and within groups comparison, in Manual Preference
Description
Outcome Measure - Manual Preference Questionnaire to assess manual preference
Time Frame
0, 4, 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena IF Coradinho, MSc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helena Isabel Falcão Coradinho
City
Évora
ZIP/Postal Code
7040
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20373859
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.
Results Reference
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Citation
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
Results Reference
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PubMed Identifier
16541981
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
27085075
Citation
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.
Results Reference
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Citation
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
Results Reference
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PubMed Identifier
19945252
Citation
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.
Results Reference
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Citation
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.
Results Reference
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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
Results Reference
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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
Results Reference
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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.
Results Reference
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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
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Citation
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Citation
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Results Reference
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Citation
Matias A, Vieira C. Programa de intervenção grafomotora. [In press].
Results Reference
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Graphomotor Intervention Program for Handwriting Difficulties Prevention in School-Age

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