UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059710 |
|---|---|
| Receipt number | R000068295 |
| Scientific Title | A Randomized Controlled Trial of Perceptual-Motor Training on Postural Control and Social Interaction in Children with Autism Spectrum Disorder: Gender Differences in Treatment Outcomes |
| Date of disclosure of the study information | 2025/12/03 |
| Last modified on | 2025/11/10 03:12:27 |
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Basic information
Public title
A Randomized Controlled Trial of Perceptual-Motor Training on Postural Control and Social Interaction in Children with Autism Spectrum Disorder: Gender Differences in Treatment Outcomes
Acronym
A Randomized Controlled Trial of Perceptual-Motor Training on Postural Control and Social Interaction in Children with Autism Spectrum Disorder: Gender Differences in Treatment Outcomes
Scientific Title
A Randomized Controlled Trial of Perceptual-Motor Training on Postural Control and Social Interaction in Children with Autism Spectrum Disorder: Gender Differences in Treatment Outcomes
Scientific Title:Acronym
A Randomized Controlled Trial of Perceptual-Motor Training on Postural Control and Social Interaction in Children with Autism Spectrum Disorder: Gender Differences in Treatment Outcomes
Region
| Asia(except Japan) |
Condition
Condition
Pre- Post
Classification by specialty
| Neurology | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine gender differences in response to perceptual-motor training on postural control and social interaction in children with autism spectrum disorder (ASD) through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postural control (NeuroCom posturography: COG changes in X/Y axes, equilibrium scores across 6 sensory conditions)
Key secondary outcomes
social interaction (SRS-2 total score)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Other |
Interventions/Control_1
6-week perceptual-motor training program
Interventions/Control_2
Control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 7 | years-old | <= |
Age-upper limit
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age between 7 and 13 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) according to DSM-5 criteria and GARS-2 scale scoring at Level 2 or Level 3 (requiring substantial or very substantial support).
Both genders (male and female).
No concurrent neurological disorders (e.g., epilepsy, cerebral palsy, or genetic syndromes associated with motor impairment).
Ability to participate in simple motor activities without requiring full physical assistance or supportive devices (independent ambulation and basic gross motor skills intact).
No use of medications affecting balance, motor control, or social interaction (e.g., antipsychotics, stimulants, anticonvulsants, or benzodiazepines) in the past 3 months.
Informed consent and written assent obtained from parents/legal guardians and, when possible, from the child (according to ethical guidelines for pediatric research).
Key exclusion criteria
Presence of severe sensory impairments (uncorrected profound hearing loss or legal blindness).
Concurrent participation in other interventional studies targeting motor or social skills.
Recent orthopedic injuries or surgeries affecting mobility in the past 6 months.
Intellectual disability (IQ < 70) with significant adaptive functioning deficits that prevent comprehension of simple instructions.
History of aggressive behavior that poses safety risks during group activities.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Rozhin |
| Middle name | |
| Last name | Golestani |
Organization
shahid behshti
Division name
SBU
Zip code
14911-15719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
roozhingolestani@gmail.com
Public contact
Name of contact person
| 1st name | Rozhin |
| Middle name | |
| Last name | Golestani |
Organization
shahid behshti
Division name
SBU
Zip code
14911-15719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
Homepage URL
roozhingolestani@gmail.com
Sponsor or person
Institute
self funding
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shahid Behshti
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
Tel
989336487376
roozhingolestani@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068295
