Back to resultsSensory Integration Versus Fine Motor Intervention in Children With Autism
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fine motor skills
sensory integration
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Quality of life, sensory integration, fine motor skills
Eligibility Criteria
Inclusion Criteria:
- Age ranges from 8 to 12 years.
- Mild to moderate autistic features according Gilliam autism rating scale: (scores from 60 to 110).
- Mild to moderate mental retardation (IQ of 35-70).
- Can understand and follow simple instructions.
Exclusion Criteria:
- Significant visual or auditory defects.
- History of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder).
- History of surgical interference or fractures of the upper limbs in the last 12 months.
Sites / Locations
- faculty of physical therapy, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
conventional training
sensory integration training
Arm Description
children in this group will receive fine motor exercises to enhance fine motor skills for one hour for each child, three times per week along a period of three months
Children in this group will receive designed sensory integration program, one hour for each child, three times per week along a period of three months.
Outcomes
Primary Outcome Measures
Gilliam autism rating scale
Items on the developmental sub scale address behaviors and milestones in the first 36 months of life. The four sub scales are summed to provide an autism index. The higher the autism index, the higher the probability the individual has autism and the more severe the autistic behavior
Secondary Outcome Measures
Bruininks-Oseretsky Test Of Motor Proficiency
Fine manual control domain will be assessed in the current study. The fine manual control domains contain two sub tests fine motor precision and fine motor integration. Total motor composite and subtest measures are available as a raw score, standard score, percentile rank and descriptive category ("well below average", "below average', "average" above average and "well above average"). Gender specific norms were used for scoring as the scale's authors report these as being more accurate than combined gender norms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04696133
Brief Title
Sensory Integration Versus Fine Motor Intervention in Children With Autism
Official Title
Therapeutic Outcomes of Sensory Integration Versus Fine Motor Intervention on Autistic Features and Fine Motor Skills in Children With Autism: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
August 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Clinically, infants with Autism spectrum often display gross motor delays in supine, prone, and sitting skills in their first year of life. Delay in crawling, walking, and achieving other motor milestones are frequently observed in toddler hood. In addition, difficulties in fine motor skills are frequent in individuals with Autism spectrum.
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, Quality of life, sensory integration, fine motor skills
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional training
Arm Type
Experimental
Arm Description
children in this group will receive fine motor exercises to enhance fine motor skills for one hour for each child, three times per week along a period of three months
Arm Title
sensory integration training
Arm Type
Experimental
Arm Description
Children in this group will receive designed sensory integration program, one hour for each child, three times per week along a period of three months.
Intervention Type
Other
Intervention Name(s)
fine motor skills
Intervention Description
stretching and strengthening exercises in addition to exercises to enhance fine motor skills
Intervention Type
Other
Intervention Name(s)
sensory integration
Intervention Description
Tactile stimulation
Proprioceptive stimulation
Heavy work activities (i.e., proprioceptive input)
Primary Outcome Measure Information:
Title
Gilliam autism rating scale
Description
Items on the developmental sub scale address behaviors and milestones in the first 36 months of life. The four sub scales are summed to provide an autism index. The higher the autism index, the higher the probability the individual has autism and the more severe the autistic behavior
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Bruininks-Oseretsky Test Of Motor Proficiency
Description
Fine manual control domain will be assessed in the current study. The fine manual control domains contain two sub tests fine motor precision and fine motor integration. Total motor composite and subtest measures are available as a raw score, standard score, percentile rank and descriptive category ("well below average", "below average', "average" above average and "well above average"). Gender specific norms were used for scoring as the scale's authors report these as being more accurate than combined gender norms
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ranges from 8 to 12 years.
Mild to moderate autistic features
Exclusion Criteria:
• Significant visual or auditory defects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emam H El-Negamy, professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
kamilia saad
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
dalia galal
Organizational Affiliation
Cairo university, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of physical therapy, Cairo university
City
Giza
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Sensory Integration Versus Fine Motor Intervention in Children With Autism
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