A Handwriting Intervention Program for Children With Tic Disorders

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Tourette Syndrome; Tic Disorders
• Intervention / Treatment: Other: Handwriting intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Rowe, Dr. OT; Phone Number: 205-638-6820; Email: Jan.rowe@childrensal.org

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0104
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Tourette syndrome
• Diagnosed tic disorder

Exclusion Criteria:

• Diagnosed anxiety disorder
• Diagnosed learning disability
• Diagnosed dysgraphia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Participants are diagnosed with tic disorder and/or Tourette syndrome. They will undergo treatment to improve overall handwriting skills.	Other: Handwriting intervention; children will practice handwriting 5 days p/week, 15-20 minutes p/day for 12 weeks using the movalyzer software program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Scores of handwriting competence for legibility	Scores are recorded by standard scores with a mean of 100.	Post treatment, after week 12
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
Scores of handwriting competence for speed	Scores are recorded by standard scores with a mean of 100	Post treatment, after week 12
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Jan Rowe, Dr OT, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Actual): December 18, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Handwriting; Pediatrics
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tourette Syndrome; Tic Disorders; Tics
• Other Study ID Numbers: IRB-300003428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No