Clinical trial NCT04246112: A Handwriting Intervention Program for Children With Tic Disorders
Official title: A Handwriting Intervention Program for Children With Tic Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome
Tic Disorders
Keywords: Handwriting
Pediatrics
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 12
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Tourette syndrome
* Diagnosed tic disorder

Exclusion Criteria:

* Diagnosed anxiety disorder
* Diagnosed learning disability
* Diagnosed dysgraphia

Primary outcomes:
measure: Scores of handwriting competence for legibility
timeFrame: Pre treatment, baseline
measure: Scores of handwriting competence for legibility
timeFrame: Post treatment, after week 12
measure: Scores of handwriting competence for speed
timeFrame: Pre treatment, baseline
measure: Scores of handwriting competence for speed
timeFrame: Post treatment, after week 12
measure: Percentage of handwriting competence for reversal of letters
timeFrame: Pre treatment, baseline
measure: Percentage of handwriting competence for reversal of letters
timeFrame: Post treatment, after week 12
measure: Percentage of handwriting competence for letters touching one another
timeFrame: Pre treatment, baseline
measure: Percentage of handwriting competence for letters touching one another
timeFrame: Post treatment, after week 12
measure: Percentage of handwriting competence for case errors
timeFrame: Pre treatment, baseline
measure: Percentage of handwriting competence for case errors
timeFrame: Post treatment, after week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jan Rowe, Dr OT
role: PRINCIPAL_INVESTIGATOR
References: