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Effects of Motor Skill Occupational Therapy Intervention ON ASD (Motion ASD)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
motor intervention
cognitive intervention
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism spectrum disorder, motor skills, adaptive functions

Eligibility Criteria

4 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

motor intervention

cognitive intervention

Arm Description

Children in the motor intervention group will receive a 8-week motor intervention program. Each week will be of 1.5-hour duration.

Children in the cognitive intervention group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2021
Last Updated
March 21, 2023
Sponsor
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT05131347
Brief Title
Effects of Motor Skill Occupational Therapy Intervention ON ASD (Motion ASD)
Official Title
Effects of a Motor Intervention Program on Motor Skills and Adaptive Functions for Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism spectrum disorder, motor skills, adaptive functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
motor intervention
Arm Type
Experimental
Arm Description
Children in the motor intervention group will receive a 8-week motor intervention program. Each week will be of 1.5-hour duration.
Arm Title
cognitive intervention
Arm Type
Active Comparator
Arm Description
Children in the cognitive intervention group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration.
Intervention Type
Behavioral
Intervention Name(s)
motor intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
cognitive intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form
Description
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.
Time Frame
8 weeks
Title
Vineland Adaptive Behavior Scales-Third Edition
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling-Yi Lin, ScD
Phone
+88662353535
Ext
5917
Email
lingyi@mail.ncku.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Ru Jin, BS
Phone
+88662353535
Ext
5944
Email
siywe30a@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling-Yi Lin, ScD
Organizational Affiliation
National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling-Yi Lin, ScD
Phone
+88662353535
Ext
5917
Email
lingyi@mail.ncku.edu.tw
First Name & Middle Initial & Last Name & Degree
Yu-Ru Jin, BS
Phone
+88662353535
Ext
5944
Email
siywe30a@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32899306
Citation
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.
Results Reference
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Effects of Motor Skill Occupational Therapy Intervention ON ASD (Motion ASD)

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