A Handwriting Intervention Program for Children With Tic Disorders
Primary Purpose
Tourette Syndrome, Tic Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Handwriting intervention
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome focused on measuring Handwriting, Pediatrics
Eligibility Criteria
Inclusion Criteria:
- Tourette syndrome
- Diagnosed tic disorder
Exclusion Criteria:
- Diagnosed anxiety disorder
- Diagnosed learning disability
- Diagnosed dysgraphia
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Participants are diagnosed with tic disorder and/or Tourette syndrome. They will undergo treatment to improve overall handwriting skills.
Outcomes
Primary Outcome Measures
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.
Scores of handwriting competence for legibility
Scores are recorded by standard scores with a mean of 100.
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.
Scores of handwriting competence for speed
Scores are recorded by standard scores with a mean of 100
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.
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).
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.
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).
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04246112
First Posted
October 14, 2019
Last Updated
August 15, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04246112
Brief Title
A Handwriting Intervention Program for Children With Tic Disorders
Official Title
A Handwriting Intervention Program for Children With Tic Disorders.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Tic Disorders
Keywords
Handwriting, Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Participants are diagnosed with tic disorder and/or Tourette syndrome. They will undergo treatment to improve overall handwriting skills.
Intervention Type
Other
Intervention Name(s)
Handwriting intervention
Intervention Description
children will practice handwriting 5 days p/week, 15-20 minutes p/day for 12 weeks using the movalyzer software program.
Primary Outcome Measure Information:
Title
Scores of handwriting competence for legibility
Description
Scores are recorded by standard scores. Children scoring greater than 1 standard deviation below the mean of 100 will receive intervention.
Time Frame
Pre treatment, baseline
Title
Scores of handwriting competence for legibility
Description
Scores are recorded by standard scores with a mean of 100.
Time Frame
Post treatment, after week 12
Title
Scores of handwriting competence for speed
Description
Scores are recorded by standard scores. Children scoring greater than 1 standard deviation below the mean of100 will receive intervention.
Time Frame
Pre treatment, baseline
Title
Scores of handwriting competence for speed
Description
Scores are recorded by standard scores with a mean of 100
Time Frame
Post treatment, after week 12
Title
Percentage of handwriting competence for reversal of letters
Description
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.
Time Frame
Pre treatment, baseline
Title
Percentage of handwriting competence for reversal of letters
Description
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).
Time Frame
Post treatment, after week 12
Title
Percentage of handwriting competence for letters touching one another
Description
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.
Time Frame
Pre treatment, baseline
Title
Percentage of handwriting competence for letters touching one another
Description
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).
Time Frame
Post treatment, after week 12
Title
Percentage of handwriting competence for case errors
Description
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.
Time Frame
Pre treatment, baseline
Title
Percentage of handwriting competence for case errors
Description
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).
Time Frame
Post treatment, after week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Tourette syndrome
Diagnosed tic disorder
Exclusion Criteria:
Diagnosed anxiety disorder
Diagnosed learning disability
Diagnosed dysgraphia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Rowe, Dr OT
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To be determined
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A Handwriting Intervention Program for Children With Tic Disorders
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