Tourette SyndromeNCT04246112
A Handwriting Intervention Program for Children With Tic Disorders
A study testing Handwriting intervention in people with Tourette Syndrome and Tic Disorders, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Tourette Syndrome, Tic Disorders
- What is being tested?
- Handwriting intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Tourette syndrome
- Diagnosed tic disorder
Who cannot join
- Diagnosed anxiety disorder
- Diagnosed learning disability
- Diagnosed dysgraphia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0104
About this study
Official title: A Handwriting Intervention Program for Children With Tic Disorders.
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.
- Conditions
- Tourette Syndrome, Tic Disorders
- Being tested
- Handwriting intervention
- Keywords
- Handwriting, Pediatrics
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handwriting interventionOther
children will practice handwriting 5 days p/week, 15-20 minutes p/day for 12 weeks using the movalyzer software program.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants are diagnosed with tic disorder and/or Tourette syndrome. They will undergo treatment to improve overall handwriting skills. Receives: Other: Handwriting intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre treatment, baseline
Scores of handwriting competence for legibility
Scores are recorded by standard scores with a mean of 100.
Measured: 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.
Measured: Pre treatment, baseline
Scores of handwriting competence for speed
Scores are recorded by standard scores with a mean of 100
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Post treatment, after week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start12 Jan 2021
- Primary completion18 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Rowe, University of Alabama at Birmingham
- Investigators
- Jan Rowe, Dr OT, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246112
- Sponsor's protocol ID
- IRB-300003428
- Other IDs
- Departmental funding
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2019
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Handwriting Intervention Program for Children With Tic Disorders.
- ClinicalTrials.gov ID
- NCT04246112
- Acronym / sponsor ID
- IRB-300003428
- Conditions
- Tourette Syndrome, Tic Disorders
- Keywords
- Handwriting, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Handwriting interventionParticipants are diagnosed with tic disorder and/or Tourette syndrome. They will undergo treatment to improve overall handwriting skills. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Tourette syndrome
- Diagnosed tic disorder
Key exclusion criteria (3 listed)
- Diagnosed anxiety disorder
- Diagnosed learning disability
- Diagnosed dysgraphia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handwriting interventionchildren will practice handwriting 5 days p/week, 15-20 minutes p/day for 12 weeks using the movalyzer software program. | Other | Treatment group |
Primary outcome
Scores of handwriting competence for legibility
Time frame: Pre treatment, baseline
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
Time frame: Post treatment, after week 12
Scores are recorded by standard scores with a mean of 100.
Scores of handwriting competence for speed
Time frame: Pre treatment, baseline
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
Time frame: Post treatment, after week 12
Scores are recorded by standard scores with a mean of 100
Percentage of handwriting competence for reversal of letters
Time frame: 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.
Percentage of handwriting competence for reversal of letters
Time frame: 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).
Percentage of handwriting competence for letters touching one another
Time frame: 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.
Percentage of handwriting competence for letters touching one another
Time frame: 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).
Percentage of handwriting competence for case errors
Time frame: 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.
Percentage of handwriting competence for case errors
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Rowe, Dr OT principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handwriting intervention in people with Tourette Syndrome and Tic Disorders, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of handwriting competence for legibility (time frame: Pre treatment, baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.