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OpenTrials
Completed

NCT Number: NCT05650489

Autistic Features in Relation to Motor Function and Quality of Life in Children With an Autism Spectrum Disorder

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

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amira Mahmoud Abd-elmonem

Giza, 12662, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Assessment

Other

correlation between Autistic features, motor function and quality of life

Primary outcomes

  1. Autism Index

    Time frame: baseline assessment

    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

  2. Motor Development

    Time frame: baseline assessment

    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
  3. Pediatric Quality of life Inventory Scale

    Time frame: baseline assessment

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2022
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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