Autism Spectrum DisorderNCT05131347
Effects of Motor Skill Occupational Therapy Intervention ON ASD (Motion ASD)
A study testing motor intervention and cognitive intervention in people with Autism Spectrum Disorder, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
The study will be a randomized controlled trial, which will aim to establish the appropriate and feasible content of the planned motor intervention program. A sample of 30 young children with ASD (4 to 5 years old) will be randomly assigned to treatment and control groups. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- motor intervention and cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 May 2022to 13 Nov 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 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with ASD by registered pediatric psychiatrists according to the Diagnostic and Statistical Manual-5th Edition
- aged 48 to 71 months old
- had no sensory impairments, such as visual or hearing impairments
Who cannot join
- diagnosed with additional diseases, comorbidities, or presence of other disorders, such as epilepsy, attention deficit hyperactivity disorder (ADHD), or Fragile X syndrome
- children with physical disabilities caused by head injuries, or neurological disorders
- the inability to follow researcher's instructions and complete the research procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Motor Intervention Program on Motor Skills and Adaptive Functions for Children With Autism Spectrum Disorder
The study will be a randomized controlled trial, which will aim to establish the appropriate and feasible content of the planned motor intervention program. A sample of 30 young children with ASD (4 to 5 years old) will be randomly assigned to treatment and control groups. Children in the treatment group will receive a 8-week motor skill intervention program. Children in the control group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration. Outcome measurements will consist of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition Brief Form and Vineland Adaptive Behavior Scales-Third Edition. A two-factor mixed design ANOVA will be conducted to compare pre- and post-tests differences in the treatment and control groups. The findings of the proposed study will be useful for occupational therapists and clinicians to assist caregivers in implementing the intervention program and will contribute to knowledge regarding the effects of motor intervention program on increasing the motor skills of young children with ASD in Taiwan. Practitioners can design a standard treatment manual and provide information for implementing the motor intervention program. The expected results will help clinicians apply empirical knowledge to provide and promote the health and development of young children with ASD.
Read the detailed description
Introduction: Preschool children with autism spectrum disorder may have motor difficulties in performing daily activities. Therefore, effective and economical interventions are very important to support them. However, the empirical evidence was still weak due to poor research designs and little research was comprehensively investigated children's motor performance. Aim: This study will implement a dose-matched control group and comprehensive measurements to examine if the motor skill intervention program will improve children's motor performance. Hypotheses: The hypothesis will be that the better improvements would show in the motor skill intervention program than those in the cognitive training program. Method: Thirty preschool children with autism spectrum disorder will be recruited and randomly assigned to either the motor skill intervention program group or the cognitive training program group after pretest phase. Both groups will conduct 8-week intervention programs and be assessed after interventions. Children's motor performance will be assessed by the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition Brief Form and the Vineland Adaptive Behavior Scales.
- Conditions
- Autism Spectrum Disorder
- Being tested
- motor intervention, cognitive intervention
- Keywords
- autism spectrum disorder, motor skills, adaptive functions
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor interventionBehavioural
Children in the motor intervention group will receive motor skills training based on motor learning theory. Movement activities include playing on trampoline and tilt board, walking on knees, toes and heels, creeping and crawling under different obstacles, jumping forward and backward, driving scooter board, playing balance devices, hopping, and visual motor coordinated movement. These activities are designed from easy to complex.
cognitive interventionBehavioural
Children in the cognitive intervention group will receive cognitive training. The activities consist of 12 exercises with progressive cognitive demands at 10 levels to improve cognitive functions such as attention, cognitive flexibility, inhibitory control, and working memory.
| Study group | Role | What they receive |
|---|---|---|
| motor intervention | Experimental | Children in the motor intervention group will receive a 8-week motor intervention program. Each week will be of 1.5-hour duration. Receives: Behavioral: motor intervention |
| cognitive intervention | Active comparator | Children in the cognitive intervention group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration. Receives: Behavioral: cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form
The Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form uses a subtest and composite structure that highlights motor performance in the broad functional areas of stability, mobility, strength, coordination, and object manipulation. Scale scores (mean = 15, standard deviation = 5), confidence intervals, age equivalents, and descriptive categories are used to describe subtest performance. Standard scores (mean = 50, standard deviation = 10), confidence intervals, percentile ranks, and descriptive categories are used to describe motor performance. The higher the scores are, the better performance the children achieve.
Measured: 8 weeks
Vineland Adaptive Behavior Scales-Third Edition
The Vineland Adaptive Behavior Scales-Third Edition (VABS-3) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start6 May 2022
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Yi Lin, National Cheng Kung University
- Investigators
- Ling-Yi Lin, ScD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131347
- Sponsor's protocol ID
- A-BR-109-011
- Status last verified
- May 2025
- First submitted
- 28 Oct 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alsaedi RH. An Assessment of the Motor Performance Skills of Children with Autism Spectrum Disorder in the Gulf Region. Brain Sci. 2020 Sep 3;10(9):607. doi: 10.3390/brainsci10090607.
PubMed 32899306
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Motor Intervention Program on Motor Skills and Adaptive Functions for Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05131347
- Acronym / sponsor ID
- A-BR-109-011
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, motor skills, adaptive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 23 Nov 2021 (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 study will be a randomized controlled trial, which will aim to establish the appropriate and feasible content of the planned motor intervention program. A sample of 30 young children with ASD (4 to 5 years old) will be randomly assigned to treatment and control groups. Children in the treatment group will receive a 8-week motor skill intervention program. Children in the control group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration. Outcome measurements will consist of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition Brief Form and Vineland Adaptive Behavior Scales-Third Edition. A two-factor mixed design ANOVA will be conducted to compare pre- and post-tests differences in the treatment and control groups. The findings of the proposed study will be useful for occupational therapists and clinicians to assist caregivers in implementing the intervention program and will contribute to knowledge regarding the effects of motor intervention program on increasing the motor skills of young children with ASD in Taiwan. Practitioners can design a standard treatment manual and provide information for implementing the motor intervention program. The expected results will help clinicians apply empirical knowledge to provide and promote the health and development of young children with ASD.
Detailed description
Introduction: Preschool children with autism spectrum disorder may have motor difficulties in performing daily activities. Therefore, effective and economical interventions are very important to support them. However, the empirical evidence was still weak due to poor research designs and little research was comprehensively investigated children's motor performance. Aim: This study will implement a dose-matched control group and comprehensive measurements to examine if the motor skill intervention program will improve children's motor performance. Hypotheses: The hypothesis will be that the better improvements would show in the motor skill intervention program than those in the cognitive training program. Method: Thirty preschool children with autism spectrum disorder will be recruited and randomly assigned to either the motor skill intervention program group or the cognitive training program group after pretest phase. Both groups will conduct 8-week intervention programs and be assessed after interventions. Children's motor performance will be assessed by the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition Brief Form and the Vineland Adaptive Behavior Scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| motor intervention | Experimental | Behavioral: motor interventionChildren in the motor intervention group will receive a 8-week motor intervention program. Each week will be of 1.5-hour duration. |
| cognitive intervention | Active comparator | Behavioral: cognitive interventionChildren in the cognitive intervention group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosed with ASD by registered pediatric psychiatrists according to the Diagnostic and Statistical Manual-5th Edition
- aged 48 to 71 months old
- had no sensory impairments, such as visual or hearing impairments
Key exclusion criteria (3 listed)
- diagnosed with additional diseases, comorbidities, or presence of other disorders, such as epilepsy, attention deficit hyperactivity disorder (ADHD), or Fragile X syndrome
- children with physical disabilities caused by head injuries, or neurological disorders
- the inability to follow researcher's instructions and complete the research procedures
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 |
|---|---|---|
| motor interventionChildren in the motor intervention group will receive motor skills training based on motor learning theory. Movement activities include playing on trampoline and tilt board, walking on knees, toes and heels, creeping and crawling under different obstacles, jumping forward and backward, driving scooter board, playing balance devices, hopping, and visual motor coordinated movement. These activities are designed from easy to complex. | Behavioural | motor intervention |
| cognitive interventionChildren in the cognitive intervention group will receive cognitive training. The activities consist of 12 exercises with progressive cognitive demands at 10 levels to improve cognitive functions such as attention, cognitive flexibility, inhibitory control, and working memory. | Behavioural | cognitive intervention |
Primary outcome
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form
Time frame: 8 weeks
The Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form uses a subtest and composite structure that highlights motor performance in the broad functional areas of stability, mobility, strength, coordination, and object manipulation. Scale scores (mean = 15, standard deviation = 5), confidence intervals, age equivalents, and descriptive categories are used to describe subtest performance. Standard scores (mean = 50, standard deviation = 10), confidence intervals, percentile ranks, and descriptive categories are used to describe motor performance. The higher the scores are, the better performance the children achieve.
Vineland Adaptive Behavior Scales-Third Edition
Time frame: 8 weeks
The Vineland Adaptive Behavior Scales-Third Edition (VABS-3) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.
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 30 May 2025.
- Background: PubMed 32899306Alsaedi RH. An Assessment of the Motor Performance Skills of Children with Autism Spectrum Disorder in the Gulf Region. Brain Sci. 2020 Sep 3;10(9):607. doi: 10.3390/brainsci10090607.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Ling-Yi Lin, ScD principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor intervention and cognitive intervention in people with Autism Spectrum Disorder, run by National Cheng Kung University 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 3 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 30 May 2025. 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?
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05131347, which also lists 1 linked publication.
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 30 May 2025.