Children With Autism Spectrum DisorderNCT06228885
Investigating Handwriting Characteristics and Underlying Factor in Children With Autism Spectrum Disorder
An observational study of Children With Autism Spectrum Disorder and Typical Developed Children, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Autism Spectrum Disorder, Typical Developed Children
- What is being tested?
- handwriting experiment and motor ability test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Dec 2022to 31 Dec 2023
- Phase
- Observational
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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")
Who may be able to join
- Age between 5-12 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- handwriting experiment and motor ability test
- Keywords
- Autism, Handwriting, Kinetic and kinematic, Cortical activation, Sensorimotor
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handwriting experiment and motor ability testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with Autism Spectrum Disorder | Not described Receives: Behavioral: handwriting experiment and motor ability test | |
| Typical developed children | Not described Receives: Behavioral: handwriting experiment and motor ability test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force-acquisition pen (FAP) system
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.
Measured: baseline
Pinch-Holding-Up Activity (PHUA) test
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.
Measured: baseline
Movement Assessment Battery for Children Second Edition (MABC-2)
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.
Measured: baseline
Chinese Handwriting Evaluation Form (CHEF)
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.
Measured: baseline
Secondary outcomes (1)
Near Infrared Spectroscopy (NIRS)
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start27 Dec 2022
- Primary completion1 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228885
- Sponsor's protocol ID
- A-ER-111-277
- Status last verified
- Dec 2023
- First submitted
- 27 Dec 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Unique Motor Characteristics and Corresponding Cortical Activation During Handwriting -- in 5-12 Year-old Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06228885
- Acronym / sponsor ID
- A-ER-111-277
- Keywords
- Autism, Handwriting, Kinetic and kinematic, Cortical activation, Sensorimotor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Jan 2024 (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 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Autism Spectrum Disorder | – | Behavioral: handwriting experiment and motor ability test |
| Typical developed children | – | Behavioral: handwriting experiment and motor ability test |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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")
Key inclusion criteria (1 listed)
- Age between 5-12 years old
Key exclusion criteria (3 listed)
- 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
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 experiment and motor ability testParticipants 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. | Behavioural | Children with Autism Spectrum Disorder, Typical developed children |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Near Infrared Spectroscopy (NIRS)
Time frame: baseline
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 29 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children With Autism Spectrum Disorder and Typical Developed Children, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 1 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 29 Jan 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 Taiwan. 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?
Force-acquisition pen (FAP) system (time frame: baseline). The study lists 4 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 29 Jan 2024.