- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696133
Sensory Integration Versus Fine Motor Intervention in Children With Autism
March 7, 2024 updated by: Amira Mahmoud Abd-elmonem, Cairo University
Therapeutic Outcomes of Sensory Integration Versus Fine Motor Intervention on Autistic Features and Fine Motor Skills in Children With Autism: A Randomized Controlled Trial
Clinically, infants with Autism spectrum often display gross motor delays in supine, prone, and sitting skills in their first year of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Many studies demonstrated that improvements in sensory-motor skills, motor planning, and reading related skills in children with learning and intellectual disabilities were seen using sensory integration and fine motor intervention.
However, there are limited studies investigating the effectiveness of sensory integration/occupational therapy on autistic features (stereotype movement, communication, and social interaction).
Fine motor skills and quality of life of children with Autism spectrum are markedly affected which might be related to the stereotype movement and limited social interactions.
Therefore, this study will be conducted to investigate and compare between the therapeutic outcomes of sensory SI and fine motor intervention on autistic features, fine motor skills and quality of life of children with Autism spectrum.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 8 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ranges from 8 to 12 years.
- Mild to moderate autistic features
Exclusion Criteria:
• Significant visual or auditory defects.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: conventional training
children received fine motor exercises
|
stretching and strengthening exercises in addition to exercises to enhance fine motor skills
Other Names:
|
|
Experimental: sensory integration training
Children received designed sensory integration program
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gilliam autism rating scale
Time Frame: 3 months
|
higher the autism index, indicate the probability the individual has autism
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bruininks-Oseretsky Test Of Motor Proficiency
Time Frame: 3 months
|
Fine manual control domain will be assessed in the current study.
Gender specific norms were used for scoring as the scale's authors report these as being more accurate than combined gender norms
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Emam H El-Negamy, professor, Cairo University
- Study Director: kamilia saad, Cairo University
- Principal Investigator: dalia galal, cairo university, Egypt
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2020
Primary Completion (Actual)
May 15, 2022
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
January 3, 2021
First Submitted That Met QC Criteria
January 4, 2021
First Posted (Actual)
January 6, 2021
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Autism spectrum
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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