Posture, Hand Functions and Sensory Processing Skills on Nutrition

Autism Spectrum Disorder Clinical Trial

Official title:

The Effect of Posture, Hand Functions and Sensory Processing Skills on Nutrition in Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06209463
• Other study ID #: 5325597167
• Status: Completed
• Start date: November 20, 2023
• Est. completion date: January 2, 2024

Study information

• Verified date: January 2024
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• ASD
• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Eyüp
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Bezmialem Vakif University	Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Margari L, Marzulli L, Gabellone A, de Giambattista C. Eating and Mealtime Behaviors in Patients with Autism Spectrum Disorder: Current Perspectives. Neuropsychiatr Dis Treat. 2020 Sep 11;16:2083-2102. doi: 10.2147/NDT.S224779. eCollection 2020. — View Citation

Matson JL, Kuhn DE. Identifying feeding problems in mentally retarded persons: development and reliability of the screening tool of feeding problems (STEP). Res Dev Disabil. 2001 Mar-Apr;22(2):165-72. doi: 10.1016/s0891-4222(01)00065-8. — View Citation

Matson ML, Matson JL, Beighley JS. Comorbidity of physical and motor problems in children with autism. Res Dev Disabil. 2011 Nov-Dec;32(6):2304-8. doi: 10.1016/j.ridd.2011.07.036. Epub 2011 Sep 3. — View 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 Dis — View Citation

Nilsen AKO, Anderssen SA, Johannessen K, Aadland KN, Ylvisaaker E, Loftesnes JM, Aadland E. Bi-directional prospective associations between objectively measured physical activity and fundamental motor skills in children: a two-year follow-up. Int J Behav — View Citation

Posar A, Visconti P. Sensory abnormalities in children with autism spectrum disorder. J Pediatr (Rio J). 2018 Jul-Aug;94(4):342-350. doi: 10.1016/j.jped.2017.08.008. Epub 2017 Nov 4. — View Citation

Salahzadeh Z, Maroufi N, Ahmadi A, Behtash H, Razmjoo A, Gohari M, Parnianpour M. Assessment of forward head posture in females: observational and photogrammetry methods. J Back Musculoskelet Rehabil. 2014;27(2):131-9. doi: 10.3233/BMR-130426. — View Citation

Tsujiguchi H, Miyagi S, Nguyen TTT, Hara A, Ono Y, Kambayashi Y, Shimizu Y, Nakamura H, Suzuki K, Suzuki F, Nakamura H. Relationship between Autistic Traits and Nutrient Intake among Japanese Children and Adolescents. Nutrients. 2020 Jul 28;12(8):2258. do — View Citation

Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006. — View Citation

Weinstock-Zlotnick G, Mehta SP. A structured literature synthesis of wrist outcome measures: An evidence-based approach to determine use among common wrist diagnoses. J Hand Ther. 2016 Apr-Jun;29(2):98-110. doi: 10.1016/j.jht.2016.03.001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craniovertebral angle	The craniovertebral angle (CVA) measurement was used to evaluate the head posture of children. The CVA is formed by the angle created by the line connecting the midpoint of the tragus of the ear to the spinous process of C7. A marker was placed on the spinous process of C7 and the tragus. Children were instructed to move their heads up and down, gradually reducing this range of motion. After returning to their natural position, photographs were taken from the right side while looking at a fixed point to ensure correct posture. The photo was then loaded into computer software (MB Ruler 5.0), and the angle was calculated using a triangle ruler between the horizontal line passing through the C7 point and the line extending from the tragus to C7. A decrease in the CVA value (<50 degrees) indicates an increase in anterior head posture.	2 weeks
Primary	Pediatric Balance Scale	Pediatric Balance Scale (PBS) was utilized to assess postural control in children. The PBS comprises 14 subdomains, including specific movements such as sitting, standing, turning, and reaching. Each subdomain receives a score between 0 and 4. The maximum achievable score is 56, and a higher score indicates better balance skills.	2 weeks
Primary	Jebsen Taylor Hand Function Test	Jebsen Taylor Hand Function Test (JTHFT) was used to measure children's hand functions. To conduct the JTHFT, the child was seated in front of the table where the test was administered. The test consists of seven tasks, including writing a 24-word sentence, flipping five cards, picking up small objects, mimicking eating with a teaspoon and five beans, stacking four checkers, picking up and carrying five large empty tin cans, and then picking up and carrying five large full tin cans. A longer duration to perform the tasks clinically indicates a poorer hand skill performance for the child.	2 weeks
Primary	Jamar hand dynamometer	The measurement of handgrip strength was conducted with the child sitting in a chair, the arm adhered to the body, shoulders in adduction, elbows in 90° flexion, and the forearm and wrist held in a neutral position using a Jamar hydraulic dynamometer with the dominant hand. The child was instructed to grasp the dynamometer firmly and then release it once. A total of 3 measurements were taken with 30-second rest intervals, including 5-second contraction periods. The grip strength values obtained were recorded in kilograms (kg) by taking the average.	2 weeks
Primary	Dunn Sensory Profile	Children's sensory processing skills were examined using the Turkish version of the Dunn Sensory Profile. The Dunn Sensory Profile questionnaire is filled out by parents/caregivers to assess the sensory processing skills of children aged 3-10. The questionnaire consists of three main sections. The first part measures children's responses to specific sensory inputs. The second part examines the ability of children to regulate sensory inputs to carry out daily life activities. The third part investigates the behavioral and emotional characteristics that arise when children process sensory information.	2 weeks
Primary	Screening Tool of Feeding Problems (STEP)	STEP is an instrument that focuses on specific sections by categorizing the occurring feeding problems, highlighting the section it concentrates on. It is a screening tool designed with 23 questions in a Likert-type format. The test contributes to identifying the most commonly observed problem by categorizing observed feeding problems in individuals.	2 weeks
Primary	The Brief Autism Mealtime Behavior Inventory (BAMBI)	BAMBI, developed by Lukens and Lischeid, was used to identify nutritional problems in children [138]. BAMBI consists of 18 items, each presenting 5 different options indicating the frequency of occurrence.An increase in the total score of BAMBI indicates a higher prevalence of specific negative behaviors related to Oral Sensory Processing.	2 weeks
Primary	Pediatric Quality of Life Inventory-Parents Form	This scale is a tool used to assess the overall quality of life of children and adolescents aged 2-18. It includes various subdomains such as physical health, emotional function, social function, and school function to measure the quality of life of individuals in different age groups. The higher the total score on Pediatric Quality of Life Inventory-Parents Form , the better the quality of life is perceived to be.	2 weeks
Primary	Beck Depression Scale	Parents' depression levels were examined using the Beck Depression Inventory (BDI). The BDI is a 21-item questionnaire that assesses the presence and severity of depression. In the scoring system, scores ranging from 0 to 9 indicate minimal depression, 10 to 18 suggest mild depression, 19 to 29 indicate moderate depression, and scores from 30 to 63 indicate severe depression, reflecting the level of depression.	2 weeks
Primary	Beck Anxiety Scale	Parents' anxiety levels were assessed using the Beck Anxiety Inventory (BAI). The BAI is a brief 21-item questionnaire that evaluates the severity of anxiety. According to the scoring system, scores ranging from 0 to 9 indicate normal anxiety levels, 10 to 18 suggest mild to moderate anxiety, 19 to 29 indicate moderate to severe anxiety, and scores from 30 to 63 indicate a presence of very severe anxiety.	2 weeks
Primary	Trait-State Anxiety Scale	To assess the anxiety levels of parents, the State-Trait Anxiety Scale was utilized. This scale is a self-assessment questionnaire consisting of brief statements and provides a four-point Likert-type measurement. Evaluation is based on the responses of parents to questions that ask them to assess each situation. A score of 1 indicates that the specified situation does not reflect themselves at all, while a score of 4 indicates that the situation completely reflects themselves. In the State Anxiety Scale, responses indicate the intensity of emotion, thought, or behavior, while in the Trait Anxiety Scale, they are asked to specify the frequency of these elements. The total score from both inventories can range from 20 to 80. Higher scores represent higher levels of anxiety, while lower scores indicate lower levels of anxiety.	2 weeks