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Completed

NCT Number: NCT04246112

A Handwriting Intervention Program for Children With Tic Disorders

The purpose of this study is to evaluate the effectiveness of a computerized handwriting training protocol (MovAlyzeR), through daily practice of handwriting on an electronic device to improve handwriting skills in children with tic disorders (TD).

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0104, United States

About this study

Handwriting is a functional skill underlying almost all academic performance of school-aged children, and handwriting impairment is highlighted by the World Health Organization as a barrier to school participation. The available evidence mentioned in the literature suggests handwriting skills are academically crucial, and handwriting deficits may lead to challenges in performing various academic activities both in and outside the classroom.

Given that children with TD are more likely to have handwriting deficits as suggested in a recent study, they are also more likely to have challenges in their academic performance and success as evidenced in the literature.

In the context of education, strong evidence indicated that handwriting has more cognitive and neurological benefits than using a keyboard when taking notes in the classroom. Therefore, reducing tics and improving handwriting skills rather than an adaptation approach using a word processor or computer may be the goal of intervention.

Results of the investigator's previous study showed that children with Tourette Syndrome (TS) or tic disorders (TD) demonstrated handwriting deficits when compared to the general children population, and were consistent with a recent study conducted in France showing that children with TS exhibited handwriting problems. In addition to illegibility issues in handwriting as indicated by the low score on the Test of handwriting skills (THS-R), children with TS or TD also demonstrated writing deficits in the areas of speed of writing and correct letter case formation.

Since handwriting deficit is an area of concern among children with TS or TD, one way to improve these children's handwriting skills is through handwriting practice. NeuroScript, LLC., has developed a software program (MovAlyzeR) that allows children to practice handwriting on an electronic device (such as tablet, laptop, etc). Given that the practice is completed on an electronic device with immediate feedback, this handwriting program may serve as a strong incentive to motivate children practicing handwriting. In order to provide evidence for the educators and therapists on the effectiveness of this software program, it is important to evaluate its effectiveness on improving handwriting skills among children with TS or TD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tourette syndrome
  • Diagnosed tic disorder

Exclusion criteria

  • Diagnosed anxiety disorder
  • Diagnosed learning disability
  • Diagnosed dysgraphia

Treatment and study plan

Handwriting intervention

Other

children will practice handwriting 5 days p/week, 15-20 minutes p/day for 12 weeks using the movalyzer software program.

Primary outcomes

  1. Scores of handwriting competence for legibility

    Time frame: Pre treatment, baseline

    Scores are recorded by standard scores. Children scoring greater than 1 standard deviation below the mean of 100 will receive intervention.

  2. Scores of handwriting competence for legibility

    Time frame: Post treatment, after week 12

    Scores are recorded by standard scores with a mean of 100.

  3. Scores of handwriting competence for speed

    Time frame: Pre treatment, baseline

    Scores are recorded by standard scores. Children scoring greater than 1 standard deviation below the mean of100 will receive intervention.

  4. Scores of handwriting competence for speed

    Time frame: Post treatment, after week 12

    Scores are recorded by standard scores with a mean of 100

  5. Percentage of handwriting competence for reversal of letters

    Time frame: Pre treatment, baseline

    Reversal of letters are scored as an ancillary score using three categorizations: test further (i.e., below 16th percentile or more one standard deviation (SD) below the normative mean or z-score < -1), watch (i.e., between 16th percentile and 50th percentile), and no concern (i.e., 50th percentile and above). Children scoring below 16% or 1 standard deviation below will receive intervention.

  6. Percentage of handwriting competence for reversal of letters

    Time frame: Post treatment, after week 12

    Reversal of letters are scored as an ancillary score using three categorizations: test further (i.e., below 16th percentile or more one standard deviation (SD) below the normative mean or z-score < -1), watch (i.e., between 16th percentile and 50th percentile), and no concern (i.e., 50th percentile and above).

  7. Percentage of handwriting competence for letters touching one another

    Time frame: Pre treatment, baseline

    Letters touching each other are scored as an ancillary score using three categorizations: test further (i.e., below 16th percentile or more one standard deviation (SD) below the normative mean or z-score < -1), watch (i.e., between 16th percentile and 50th percentile), and no concern (i.e., 50th percentile and above). Children scoring below 16% or 1 standard deviation below will receive intervention.

  8. Percentage of handwriting competence for letters touching one another

    Time frame: Post treatment, after week 12

    Letters touching each other are scored as an ancillary score using three categorizations: test further (i.e., below 16th percentile or more one standard deviation (SD) below the normative mean or z-score < -1), watch (i.e., between 16th percentile and 50th percentile), and no concern (i.e., 50th percentile and above).

  9. Percentage of handwriting competence for case errors

    Time frame: Pre treatment, baseline

    Case errors are scored as an ancillary score using three categorizations: test further (i.e., below 16th percentile or more one standard deviation (SD) below the normative mean or z-score < -1), watch (i.e., between 16th percentile and 50th percentile), and no concern (i.e., 50th percentile and above). Children scoring below 16% or 1 standard deviation below will receive intervention.

  10. Percentage of handwriting competence for case errors

    Time frame: Post treatment, after week 12

    Case errors are scored as an ancillary score using three categorizations: test further (i.e., below 16th percentile or more one standard deviation (SD) below the normative mean or z-score < -1), watch (i.e., between 16th percentile and 50th percentile), and no concern (i.e., 50th percentile and above).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Handwriting Intervention Program for Children With Tic Disorders.

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 29, 2020
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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