- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06228885
Investigating Handwriting Characteristics and Underlying Factor in Children With Autism Spectrum Disorder
January 24, 2024 updated by: National Cheng-Kung University Hospital
Investigating the Unique Motor Characteristics and Corresponding Cortical Activation During Handwriting -- in 5-12 Year-old Children With Autism Spectrum Disorder
The mechanism of the motor problem in children with autism spectrum disorder (ASD) in handwriting has been investigated in the following three aspects, including collecting dynamic handwriting performance, exploring the related underlying factors, and investigating corresponding brain activities.
This study aimed to investigate the underlying factor of handwriting issue in children with ASD.
There are four study aims.
The first is to examine the differences of handwriting performance between children with ASD and TD using kinetic and kinematic measurements and handwriting difficulties questionnaires.
The second is to investigate the group difference of the underlying motor factors, including fine motor ability and sensorimotor ability.
The third is to explore the relationship between underlying motor factors and handwriting performance.
The fourth is to explore the corresponding cortical activity during writing in children.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tainan, Taiwan, 704
- National Cheng-Kung University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Children with ASD group:
- Meeting the criteria for ASD according to DSM-5 from psychiatrist
- ASD core symptoms: CARS higher than 30
TD group:
- The percentage score of MABC-2 is larger than 25% (not determined as "impaired motor coordination")
Description
Inclusion Criteria:
- Age between 5-12 years old
Exclusion Criteria:
- who have a diagnosis of a seizure disorder, genetic condition, neurological condition, uncorrected significant hearing or visual impairment, and/or intellectual disability
- having non-verbal intelligent ability score lower than 70, determining by TONI-3
- unable to follow instructions during the process
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with Autism Spectrum Disorder
|
Participants will be instructed to participate in a handwriting experiment, which involves utilizing a Force Acquisition Pen (FAP) system and Near Infrared Spectroscopy (NIRS) to collect force data and cortical activation, respectively, during handwriting tasks.
Children will be tasked with completing various assignments, such as tracing lines, writing numbers, and characters, among others.
Additionally, assessments of motor ability and handwriting proficiency will be conducted using the Movement Assessment Battery for Children (MABC) and the Chinese Handwriting Evaluation Form (CHEF).
The Pinch Holding Up Activity (PHUA) Test will also be administered to assess their sensorimotor ability.
|
|
Typical developed children
|
Participants will be instructed to participate in a handwriting experiment, which involves utilizing a Force Acquisition Pen (FAP) system and Near Infrared Spectroscopy (NIRS) to collect force data and cortical activation, respectively, during handwriting tasks.
Children will be tasked with completing various assignments, such as tracing lines, writing numbers, and characters, among others.
Additionally, assessments of motor ability and handwriting proficiency will be conducted using the Movement Assessment Battery for Children (MABC) and the Chinese Handwriting Evaluation Form (CHEF).
The Pinch Holding Up Activity (PHUA) Test will also be administered to assess their sensorimotor ability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Force-acquisition pen (FAP) system
Time Frame: baseline
|
FAP system was used to collect the kinetic data during the process of writing.
During the experiment, children will be asked to perform some tasks: tracing line, writing numbers, writing Bopomofo, and writing characters.
The force of thumb, index, middle fingers and pen tip will be recorded.
This is able to reflect the motor control aspect of handwriting through a variety of parameters.
The following parameters will be calculated: average force, max force ration, numbers of force fluctuation per second, … and so on.
|
baseline
|
|
Pinch-Holding-Up Activity (PHUA) test
Time Frame: baseline
|
The PHUA test is used to measure one's sensorimotor ability.
Through calculating the parameters (max pinch force, max load force, force ratio … etc) to reflect one's ability to integrate sensory and produce a new output.
A higher force ratio reflects a poorer sensorimotor ability.
|
baseline
|
|
Movement Assessment Battery for Children Second Edition (MABC-2)
Time Frame: baseline
|
The MABC test is used to measure children's motor ability, including fine motor, balance and aiming and catching ability.
The score will transform into z score and rank score, to reflect child's performance.
A higher score indicates a better motor ability.
|
baseline
|
|
Chinese Handwriting Evaluation Form (CHEF)
Time Frame: baseline
|
The CHEF is a questionnaire developed to assess and confirm the handwriting difficulties of preschooler (the third year of kindergarten) and school-aged children (grade one to two of elementary school).
The school-aged version includes 25 items within five dimensions of handwriting problem: legibility, accuracy, speed, pencil grip, and directionality; while the preschooler version includes 22 items within four dimensions of handwriting problem: legibility, function (accuracy and speed), pencil grip, and attitude.
The score is rated by teachers, parents, or familiar professionals with a 5-point Likert scale.
A larger score indicates more difficulty in handwriting.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Near Infrared Spectroscopy (NIRS)
Time Frame: baseline
|
The NIRS system measures changes in oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) as parameters to analyze cortical activation data.
During handwriting, the cortical activation will be collected to observe which brain area activates more.
|
baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test of Nonverbal Intelligence, Third Edition (TONI-3)
Time Frame: baseline
|
TONI is a test to evaluate one's nonverbal intelligence, without the influence of the confounding effects of linguistic or motor function.
Children will conduct this test during screening phase.
|
baseline
|
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Childhood Autism rating scale (CARS)
Time Frame: baseline
|
CARS is a 15-items behavioral rating scale, for examining the autism symptoms in children.
A higher score indicates more serious autistic symptoms.
Parents will assist therapists in completing this scale during the screening phase.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 27, 2022
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
December 27, 2023
First Submitted That Met QC Criteria
January 24, 2024
First Posted (Estimated)
January 29, 2024
Study Record Updates
Last Update Posted (Estimated)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-ER-111-277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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