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NCT Number: NCT06228885

Investigating Handwriting Characteristics and Underlying Factor in 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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

handwriting experiment and motor ability test

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Investigating the Unique Motor Characteristics and Corresponding Cortical Activation During Handwriting -- in 5-12 Year-old Children With Autism Spectrum Disorder

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2024
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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