ClinicalTrials.gg
CompletedNCT04246112Updated Dec 20, 2024

A Handwriting Intervention Program for Children With Tic Disorders

An interventional study of Handwriting intervention in Tourette Syndrome and Tic Disorders, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
7 Years to 17 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Tourette Syndrome
  • Tic Disorders

Keywords

  • Handwriting
  • Pediatrics
03

In context

Tourette Syndrome

240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.

This study's enrollment of 12 is below the median of 36 across 183 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Tourette syndrome
  • Diagnosed tic disorder

Exclusion criteria

Exclusion Criteria:

  • Diagnosed anxiety disorder
  • Diagnosed learning disability
  • Diagnosed dysgraphia
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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

Interventions

  • OtherHandwriting intervention

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre treatment, baseline

  2. Scores of handwriting competence for legibility

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

    Time frame: Post treatment, after week 12

  3. 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.

    Time frame: Pre treatment, baseline

  4. Scores of handwriting competence for speed

    Scores are recorded by standard scores with a mean of 100

    Time frame: Post treatment, after week 12

  5. 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.

    Time frame: Pre treatment, baseline

  6. 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).

    Time frame: Post treatment, after week 12

  7. 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.

    Time frame: Pre treatment, baseline

  8. 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).

    Time frame: Post treatment, after week 12

  9. 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.

    Time frame: Pre treatment, baseline

  10. 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).

    Time frame: Post treatment, after week 12

07

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294-0104, United States
08

References and documents

Individual participant data

Plan to share: No — To be determined

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2021 to primary completion in Dec 2023, 35 months.

Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's 35 months is close to that.

Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2019
First posted
Jan 29, 2020
StartActual
Jan 12, 2021
Primary completionActual
Dec 18, 2023
CompletionActual
May 31, 2024
Last update
Dec 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04246112
Responsible party
Jan Rowe (Primary Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Jan 29, 2020
Start date
Jan 12, 2021
Primary completion
Dec 18, 2023
Completion
May 31, 2024
Last update
Dec 20, 2024

Study contacts

Jan Rowe, Dr OT
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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