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

NCT05650489 | Completed

• 1 other identifier: autism spectrum disorder
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Autism Spectrum Disorder

Keywords

Autism; Motor function; quality of life; autistic features

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

assessment OTHER

correlation between Autistic features, motor function and quality of life

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Significant visual or auditory defects,
• history of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Amira Mahmoud Abd-elmonem

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Eman s Albadry, B.S.C

  Cairo university, faculty of physical therapy

  PRINCIPAL INVESTIGATOR

• Amr A OTHMAN

  Sohag University

  PRINCIPAL INVESTIGATOR

• MAI E ABBASS

  Cairo university, faculty of physical therapy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: April 15, 2020
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

EG (1)