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

November 13, 2023 updated by: Amira Mahmoud Abd-elmonem, Cairo University
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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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, 12662
        • Amira Mahmoud Abd-elmonem

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

5 months to 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Sample size calculation was performed using G power on the correlation between childhood autism rating scale and Quality of life for Spearman's rank correlation coefficient (rs) because it was the main outcome variable in the present study. a pilot study was performed on 5 patients and showed the correlation value was (r= 0.447226 and p<0.001; and a large effect size (f= 0.447226). On the basis of the results of the pilot study (a minimum sample size of 34 patients was calculated. A sample size was increased to 34 patients, but the number will be increased to 40 to show appropriate results) a minimum sample size of 34 patients was calculated. A sample size was increased to 34 patients, but it was increased to 40 to show appropriate results.

Description

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 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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

baseline assessment
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
baseline assessment
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

baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eman s Albadry, B.S.C, Cairo university, faculty of physical therapy
  • Study Chair: MAI E ABBASS, Cairo university, faculty of physical therapy
  • Principal Investigator: Amr A OTHMAN, Sohag University

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)

April 15, 2020

Primary Completion (Actual)

March 20, 2023

Study Completion (Actual)

March 20, 2023

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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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