A Handwriting Intervention Program for Children With Tic Disorders

Tourette Syndrome Clinical Trial

Official title:

A Handwriting Intervention Program for Children With Tic Disorders.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246112
• Other study ID #: IRB-300003428
• Status: Completed
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 31, 2024
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Tourette syndrome

• Diagnosed tic disorder

Exclusion Criteria:

• Diagnosed anxiety disorder

• Diagnosed learning disability

• Diagnosed dysgraphia

Related Conditions & MeSH terms

• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores of handwriting competence for legibility	Scores are recorded by standard scores. Children scoring greater than 1 standard deviation below the mean of 100 will receive intervention.	Pre treatment, baseline
Primary	Scores of handwriting competence for legibility	Scores are recorded by standard scores with a mean of 100.	Post treatment, after week 12
Primary	Scores of handwriting competence for speed	Scores are recorded by standard scores. Children scoring greater than 1 standard deviation below the mean of100 will receive intervention.	Pre treatment, baseline
Primary	Scores of handwriting competence for speed	Scores are recorded by standard scores with a mean of 100	Post treatment, after week 12
Primary	Percentage of handwriting competence for reversal of letters	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.	Pre treatment, baseline
Primary	Percentage of handwriting competence for reversal of letters	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).	Post treatment, after week 12
Primary	Percentage of handwriting competence for letters touching one another	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.	Pre treatment, baseline
Primary	Percentage of handwriting competence for letters touching one another	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).	Post treatment, after week 12
Primary	Percentage of handwriting competence for case errors	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.	Pre treatment, baseline
Primary	Percentage of handwriting competence for case errors	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).	Post treatment, after week 12