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Typical DevelopmentNCT03699800

Graphomotor Intervention Program for Handwriting Difficulties Prevention in School-Age

A study testing Graphomotor intervention program in people with Typical Development and Risk of Dysgraphia, run by University of Évora at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 7 to 7 yearsHealthy volunteers can take part
What is being tested?
Graphomotor intervention program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 sitePortugal
Study dates
15 Oct 2018to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children in the second grade (aged 7 years old);
  • Participation agreement;

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Helena Isabel Falcão Coradinho

    Evora, 7040

Other trials in Portugal

About this study

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

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.

Read the 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.

Being tested
Graphomotor intervention program
Keywords
Graphomotor intervention program, Second grade children, Prevention and early identification, Process and product of handwriting, Quality and speed of handwriting
Medical subject headings
Agraphia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Graphomotor intervention programOther

    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.

Study groups in NCT03699800
Study groupRoleWhat they receive
Graphomotor intervention programExperimentalThe 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).
Receives: Other: Graphomotor intervention program
Control GroupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 0, 4, 10 months

  2. 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

    Measured: 0, 4, 10 months

  3. 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

    Measured: 0, 4, 10 months

Secondary outcomes (2)

  1. 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

    Measured: 0 months

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

    Outcome Measure - Manual Preference Questionnaire to assess manual preference

    Measured: 0, 4, 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start15 Oct 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03699800
Sponsor's protocol ID
06102018
Status last verified
Mar 2020
First submitted
5 Oct 2018
Last updated
27 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20373859

  • 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

  • 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.

    PubMed 16541981

  • 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.

  • 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.

    PubMed 27085075

  • 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

  • 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.

    PubMed 19945252

  • 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.

  • 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

  • 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

  • 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.

  • 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

  • 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

  • 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.

    PubMed 23245779

  • 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.

    PubMed 21395194

Questions about this trial

What is this clinical trial studying?

A study testing Graphomotor intervention program in people with Typical Development and Risk of Dysgraphia, run by University of Évora at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline, between and within groups comparison, in Motor Performance (time frame: 0, 4, 10 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03699800, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.

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