Clinical trial NCT06209463: Posture, Hand Functions and Sensory Processing Skills on Nutrition
Official title: The Effect of Posture, Hand Functions and Sensory Processing Skills on Nutrition in Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Autism
Autism, Mild
ASD
Keywords: Autism Spectrum Disorder
posture
sensory processing
hand functions
nutrition
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2024-01-17
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Age between 5-10 years,
* Diagnosis of Autism Spectrum Disorder (ASD),
* Children scoring between 30-36.5 points on the Childhood Autism Rating Scale (CARS),
* Absence of any oral structural disorders,
* Willingness of the parent to voluntarily participate in the study

Brief summary: To examine the effects of posture, hand functions and sensory processing skills on nutrition in children with autism spectrum disorder.

The study aims to include 40 children diagnosed with Autism Spectrum Disorder (ASD), directed from the Department of Child and Adolescent Psychiatry at Istanbul University, along with their parents/caregivers, and 40 healthy children along with their parents/caregivers.

Detailed description: Parents/caregivers of children diagnosed with ASD will be assessed using a demographic information form; sensory processing (Dunn Sensory Profile); nutrition (Screening Tool for Eating Problems (STEP), Brief Autism Mealtime Behavior Inventory (BAMBI)); quality of life (Pediatric Quality of Life Inventory (PedsQL 4.0)); children will undergo assessments for balance (Pediatric Berg Balance Scale); head posture (Craniovertebral angle method), hand functions (Jebsen Taylor Hand Function Test); grip strength (Jamar Hand Dynamometer); and parents' evaluations for depression, anxiety, and stress levels (Beck Depression Inventory, Beck Anxiety Inventory, Spielberger State-Trait Anxiety Inventory).

The assessment duration, including explanations and questionnaires, will take approximately 1 hour.

Eligibility criteria: Inclusion Criteria:

* Age between 5-10 years,
* Diagnosis of Autism Spectrum Disorder (ASD),
* Children scoring between 30-36.5 points on the Childhood Autism Rating Scale (CARS),
* Absence of any oral structural disorders,
* Willingness of the parent to voluntarily participate in the study.

Exclusion Criteria:

* Absence of physical, visual, and auditory impairments other than Autism Spectrum Disorder (ASD).
* Presence of any additional neurological, genetic, or metabolic disorders.

Primary outcomes:
measure: Craniovertebral angle
timeFrame: 2 weeks
measure: Pediatric Balance Scale
timeFrame: 2 weeks
measure: Jebsen Taylor Hand Function Test
timeFrame: 2 weeks
measure: Jamar hand dynamometer
timeFrame: 2 weeks
measure: Dunn Sensory Profile
timeFrame: 2 weeks
measure: Screening Tool of Feeding Problems (STEP)
timeFrame: 2 weeks
measure: The Brief Autism Mealtime Behavior Inventory (BAMBI)
timeFrame: 2 weeks
measure: Pediatric Quality of Life Inventory-Parents Form
timeFrame: 2 weeks
measure: Beck Depression Scale
timeFrame: 2 weeks
measure: Beck Anxiety Scale
timeFrame: 2 weeks
measure: Trait-State Anxiety Scale
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
state: Eyüp
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
References:
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citation: Narzisi A, Fabbri-Destro M, Crifaci G, Scatigna S, Maugeri F, Berloffa S, Fantozzi P, Prato A, Muccio R, Valente E, Viglione V, Pecchini E, Pelagatti S, Rizzo R, Milone A, Barone R, Masi G. Sensory Profiles in School-Aged Children with Autism Spectrum Disorder: A Descriptive Study Using the Sensory Processing Measure-2 (SPM-2). J Clin Med. 2022 Mar 17;11(6):1668. doi: 10.3390/jcm11061668.
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