NCT06228885

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 29, 2024

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

December 27, 2023

Last Update Submit

January 24, 2024

Conditions

Keywords

AutismHandwritingKinetic and kinematicCortical activationSensorimotor

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    baseline

Secondary Outcomes (1)

  • Near Infrared Spectroscopy (NIRS)

    baseline

Other Outcomes (2)

  • Test of Nonverbal Intelligence, Third Edition (TONI-3)

    baseline

  • Childhood Autism rating scale (CARS)

    baseline

Study Arms (2)

Children with Autism Spectrum Disorder

Behavioral: handwriting experiment and motor ability test

Typical developed children

Behavioral: handwriting experiment and motor ability test

Interventions

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.

Children with Autism Spectrum DisorderTypical developed children

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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")

You may qualify if:

  • Age between 5-12 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 29, 2024

Study Start

December 27, 2022

Primary Completion

September 1, 2023

Study Completion

December 31, 2023

Last Updated

January 29, 2024

Record last verified: 2023-12

Locations