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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05650489
Other study ID # autism spectrum disorder
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date March 20, 2023

Study information

Verified date November 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Although motor limitations are not currently considered a as clinical manifestation of autism spectrum disorder, should not be ignored due to their high incidence and considerable influence on life quality functional activity


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 20, 2023
Est. primary completion date March 20, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: - Both sex, - age ranges from 3 to 5 years, - mild to moderate autistic features according to childhood autism rating scale , - were able to sit alone independently Exclusion Criteria: - Significant visual or auditory defects, - history of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
assessment
correlation between Autistic features, motor function and quality of life

Locations

Country Name City State
Egypt Amira Mahmoud Abd-elmonem Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Autism Index Gilliam autism rating scale:
Items on the developmental subscale address behaviors and milestones in the first 36 months of life. Items on the first three behavioral subscales are rated on a four point like scale ranging from Never Observed (0) to Frequently Observed (3). After completing it, the examiner calculated the total raw scores then converted into scaled scores and percentile ranks according to the examiner's manual. Higher scaled scores on a subscale represent severe autistic behavior. Finally, the total scaled scores were calculated to measure the autism index according to the examiner's manual. The higher the autism index, the higher the probability the individual has autism and the more severe the autistic behavior
baseline assessment
Primary Motor Development The Peabody Developmental Motor Scales-Second Edition:
The gross motor function domain will be assessed in the current study. The gross motor function domains contain four subtests. Reflexes, Stationary ,Locomotion and Object Manipulation .
Grading and Scoring of the PDMS-2 The therapist will ask the child to do a specific item and observes how the child is doing the task. Items are scored as 2, 1 or 0.
0 = child cannot or will not attempt an item or the attempt does not indicate that the specific skill is emerging
child's performance shows a clear resemblance to item mastery criteria but does not fully meet the criteria or there are signs of an emerging skill
child performs item according to the criteria specified for mastering the skill
baseline assessment
Primary Pediatric Quality of life Inventory Scale Pediatric Quality of life Inventory Scale:
The Arabic version will be used to assess quality of life. It contains questions about child's physical, emotional, social, and school functioning in the past 7 days. Parents/ child self-administered the quality of life after introductory instructions from the administrator. On the quality of life Generic Core Scales, for ease of interpretability, items are 22 reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related quality of Life. To reverse score, transform the 0-4 scale items to 0-100 as follows: 0-100, 1=75, 2= 50, 3= 25 and 4= 0. Finally, the Scale Score for each dimension and Total Scale Score were calculated
baseline assessment
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