A Handwriting Intervention Program for Children With Tic Disorders

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04246112
Collaborator
(none)
20
1
1
35.5
0.6

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Handwriting intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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.
Primary Purpose:
Treatment
Official Title:
A Handwriting Intervention Program for Children With Tic Disorders.
Actual Study Start Date :
Jan 12, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Scores of handwriting competence for legibility [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 [Post treatment, after week 12]

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

  3. Scores of handwriting competence for speed [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 [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 [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 [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 [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Tourette syndrome

  • Diagnosed tic disorder

Exclusion Criteria:
  • Diagnosed anxiety disorder

  • Diagnosed learning disability

  • Diagnosed dysgraphia

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294-0104

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jan Rowe, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT04246112
Other Study ID Numbers:
  • IRB-300003428
First Posted:
Jan 29, 2020
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jan Rowe, Primary Investigator, University of Alabama at Birmingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022