A Handwriting Intervention Program for Children With Tic Disorders

NCT04246112 | Completed

• 2 other identifiers: IRB-300003428Departmental funding
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Tourette Syndrome; Tic Disorders

Keywords

Handwriting; Pediatrics

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Treatment group

EXPERIMENTAL

Participants are diagnosed with tic disorder and/or Tourette syndrome. They will undergo treatment to improve overall handwriting skills.

Other: Handwriting intervention

Interventions

Handwriting intervention OTHER

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

Treatment group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Tourette syndrome
• Diagnosed tic disorder

You may not qualify if:

• Diagnosed anxiety disorder
• Diagnosed learning disability
• Diagnosed dysgraphia

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0104, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan Rowe, Dr OT

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant will practice 5 days p/week, 15-20 minutes p.day for 12 weeks. They will receive only feedback from the software program as they practice handwriting.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: A handwriting skills training software program MovAlyzeR® will be given and downloaded to the children's laptop computer. Participants will be requested to use the software program to practice handwriting 15-20 minutes per day, 5 days a week for 12 weeks. The MovAlyzeR® keeps track (records) all the participants' practice. MovAlyzeR is HIPPA compliant. We use the MovAlyzeR as a training device for handwriting, not for data collection. Since MovAlyzeR provides instant feedback to the user on their handwriting movement, it is a fun way for the children to practice handwriting.

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: January 29, 2020
• Study Start: January 12, 2021
• Primary Completion: December 18, 2023
• Study Completion: May 31, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)