NCT06209463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

January 5, 2024

Last Update Submit

September 23, 2025

Conditions

Keywords

Autism Spectrum Disorderposturesensory processinghand functionsnutrition

Outcome Measures

Primary Outcomes (11)

  • 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. A significant difference was found between the study and control groups in terms of CVA values, in favor of the control group (p\<0.05).

    2 weeks

  • 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. A significant difference in PBS scores was found between the study and control groups, favoring the control group (p\<0.05).

    2 weeks

  • 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. A difference was found between the two groups in terms of all JTHFT subparameter values and handgrip strength values (p\<0.05). It was observed that subjects with ASD took longer to perform all JTHFT subtests and had lower handgrip strength values.

    2 weeks

  • 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. A significant difference was found between the two groups in terms of hand grip strength values (p\<0.05). Hand grip strength values were observed to be lower in patients with ASD.

    2 weeks

  • 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. A difference was found between the study and control groups in terms of the Sensory Profile Scale subsection and total scores, in favor of the control group (p\<0.05).

    2 weeks

  • 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. A difference was found between the study and control groups in favor of the control group in all other STEP subgroup scores except for the 'aspiration risk' score (p\<0.05).

    2 weeks

  • 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. A difference was found between the study and control groups in terms of BAMBI total score, with the difference favoring the control group (p\<0.05).

    2 weeks

  • 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. A difference was found between the study and control groups in terms of Pediatric Quality of Life Inventory-Parents Form subgroups and total scores, favoring the control group (p\<0.05). Patients with ASD were observed to have lower Pediatric Quality of Life Inventory-Parents Form scores.

    2 weeks

  • 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. A difference was found between the study and control groups in terms of BDI scores (p\<0.05). It was observed that the parents of ASD patients had higher depression scores.

    2 weeks

  • 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. A difference was found between the study and control groups in terms of BAI scores (p\<0.05). It was observed that the anxiety levels of the parents of the ASD patients were higher.

    2 weeks

  • 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. A difference was found between the study and control groups in terms of State-Trait Anxiety Scale scores (p\<0.05).

    2 weeks

Study Arms (2)

Study group

40 children with autism underwent postural assessments, including measurement of craniovertebral angle (CVA) for head posture and Pediatric Balance Scale (PBS) for postural control; hand function assessments, including Jebsen Taylor Hand Function Test (JTHFT) for hand skills and Jamar hand dynamometer for hand grip strength; sensory processing assessments using Dunn Sensory Profile; nutrition problem assessments using the Screening Tool of Feeding Problems (STEP) and The Brief Autism Mealtime Behavior Inventory (BAMBI); and evaluation of life quality using the Pediatric Quality of Life Inventory-Parents Form (PedsQL-Parents Form). The Beck Depression Scale (BDI), Beck Anxiety Scale (BAI), and Trait-State Anxiety Scale were used to assess parents depression, anxiety, and anxiety status.

Control group

40 typically developing children (control group) underwent postural assessments, including measurement of craniovertebral angle (CVA) for head posture and Pediatric Balance Scale (PBS) for postural control; hand function assessments, including Jebsen Taylor Hand Function Test (JTHFT) for hand skills and Jamar hand dynamometer for hand grip strength; sensory processing assessments using Dunn Sensory Profile; nutrition problem assessments using the Screening Tool of Feeding Problems (STEP) and The Brief Autism Mealtime Behavior Inventory (BAMBI); and evaluation of life quality using the Pediatric Quality of Life Inventory-Parents Form (PedsQL-Parents Form).

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bezmialem Vakıf University

Istanbul, Eyüp, 34050, Turkey (Türkiye)

Location

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 23963268BACKGROUND
  • 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.

    PMID: 27264897BACKGROUND
  • 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.

    PMID: 11325163BACKGROUND
  • 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.

    PMID: 32982247BACKGROUND
  • 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.

    PMID: 29112858BACKGROUND
  • 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. doi: 10.3390/nu12082258.

    PMID: 32731611BACKGROUND
  • 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.

    PMID: 35329994BACKGROUND
  • 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.

    PMID: 21890317BACKGROUND
  • 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 Nutr Phys Act. 2020 Jan 2;17(1):1. doi: 10.1186/s12966-019-0902-6.

    PMID: 31898547BACKGROUND
  • 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.

    PMID: 11468499BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderLymphoma, Follicular

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • YAĞMUR AYDOĞAN

    BEZMIALEM FOUNDATION UNIVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASST.PROF

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 17, 2024

Study Start

November 20, 2023

Primary Completion

March 20, 2024

Study Completion

April 4, 2024

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations