UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057209 |
|---|---|
| Receipt number | R000065393 |
| Scientific Title | The Effects of Sensory-Motor Integration Exercises on Sensory Processing and Balance in Children with Autism Spectrum Disorder: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/03/14 |
| Last modified on | 2025/03/14 09:27:27 |
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Basic information
Public title
The Effects of Sensory-Motor Integration Exercises on Sensory Processing and Balance in Children with Autism Spectrum Disorder
Acronym
ESMIE-ASD
Scientific Title
The Effects of Sensory-Motor Integration Exercises on Sensory Processing and Balance in Children with Autism Spectrum Disorder: A Randomized Controlled Trial
Scientific Title:Acronym
ESMIE-ASD RCT
Region
| Africa |
Condition
Condition
Autism Spectrum Disorder (ASD)
Classification by specialty
| Nephrology | Psychosomatic Internal Medicine | Pediatrics |
| Psychiatry | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
- To evaluate the effects of sensory-motor integration exercises on sensory processing and balance in children with Autism Spectrum Disorder (ASD).
- To compare improvements in sensory processing and balance between children receiving sensory-motor integration exercises and those receiving conventional therapy.
- To determine the efficacy of a structured 16-week intervention in enhancing motor coordination and sensory regulation in children with ASD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
- Outcome Name: Improvement in Sensory Processing
- Measurement Tool: Short Sensory Profile (SSP)
- Time of Measurement: Baseline (Pre-Intervention) and Post-Intervention (Week 16)
- Description: The Short Sensory Profile (SSP) is a standardized parent-reported questionnaire assessing sensory processing across different domains. The score will be used to evaluate changes in sensory integration following the intervention.
Key secondary outcomes
- Outcome Name: Improvement in Balance and Postural Control
- Measurement Tool: Berg Balance Scale (BBS)
- Time of Measurement: Baseline (Pre-Intervention) and Post-Intervention (Week 16)
- Description: The Berg Balance Scale (BBS) assesses functional balance and postural stability through a 14-item test. Changes in BBS scores will indicate the intervention's effect on balance.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group will undergo a structured sensory-motor integration exercise program designed to enhance sensory processing and balance skills. The program will include:
- Balance training using stability platforms and sensory mats.
- Proprioceptive exercises such as weighted vests and resistance bands.
- Vestibular stimulation with balance boards and swings.
- Tactile stimulation using different textured materials.
- Sessions will be conducted 3 times per week for 8 weeks, each lasting 45 minutes.
Interventions/Control_2
Participants in the control group will receive usual care without any specific sensory-motor training. They will continue with their regular daily activities and therapy routines as prescribed by their healthcare providers.
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Diagnosis of Autism Spectrum Disorder (ASD) confirmed by a pediatric neurologist or psychologist.
- Aged between 6 and 12 years.
- Ability to follow basic instructions and participate in structured physical activities.
- No severe motor impairments that would prevent participation in the exercises.
- Parental/guardian consent to participate in the study.
Key exclusion criteria
- Co-occurring neurological disorders, such as cerebral palsy or epilepsy.
- Severe behavioral issues that could interfere with intervention sessions.
- Current participation in another structured sensory-motor therapy program.
- Use of medications affecting motor or cognitive function (e.g., sedatives, muscle relaxants).
- Severe visual or auditory impairments that would hinder engagement in balance-related exercises.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Mohamed |
| Middle name | Sayed Hamed |
| Last name | Aly |
Organization
Assiut University
Division name
Faculty of Sport Science, Department of Educational Sciences and Sports Psychology
Zip code
71515
Address
Faculty of Sport Science, Assiut University, Assiut, Egypt
TEL
+201128923543
mohamed.aly@aun.edu.eg
Public contact
Name of contact person
| 1st name | Mohamed |
| Middle name | Sayed Hamed |
| Last name | Aly |
Organization
Assiut University
Division name
Faculty of Sport Science, Department of Educational Sciences and Sports Psychology
Zip code
71515
Address
Faculty of Sport Science, Assiut University, Assiut, Egypt
TEL
+201128923543
Homepage URL
https://www.aun.edu.eg/physical_education/mohammed-aly
mohamed.aly@aun.edu.eg
Sponsor or person
Institute
Assiut University
Institute
Department
Personal name
Mohamed Sayed Hamed Aly
Funding Source
Organization
Assiut University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Assiut University, Faculty of Sport Sciences, Ethics Committee
Address
Faculty of Sport Science, Assiut University, Assiut, Egypt
Tel
00201013030392
e.hassan@aun.edu.eg
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
Faculty of Sport Science, Assiut University (Egypt)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 14 | 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
16
Results
The study enrolled 16 participants aged 6-12 years to assess the effects of a sensory play activity program on sensory processing and balance in children with Autism Spectrum Disorder (ASD). The intervention group demonstrated significant improvements in sensory processing and balance compared to the control group. Statistical analyses confirmed the effectiveness of the program, indicating potential benefits for children with ASD. No adverse effects were reported.
Results date posted
| 2025 | Year | 03 | Month | 05 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 15 | 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 | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065393
