NCT06995716

Brief Summary

The aim of this study is to evaluate spinal posture, mobility, balance and ankle muscle shortness in children with autism. The study will feature two groups,

  • First group will consist of children with autism
  • Second group will consist of typically developing children Childhood autism assessment scale will be completed with the families of the children included in the study. The tiptoe walking status of the children participating in the study will be observed and classified according to the tiptoe walking classification. Children's balance skills will be evaluated with pediatric berg balance test and timed get up and walk test, ankle muscle shortness will be evaluated with Gastro-Soleus shortness measurements, spinal posture and mobility will be evaluated with spinal mouse. The evaluation results of both groups will be compared. The main questions this study aims to answer are:
  • Is spinal mobility decreased in children with autism compared to typically developing children?
  • Is Thoracic kyphosis greater in children with autism compared to typically developing children?
  • Are Balance skills poorer in children with autism compared to typically developing children?
  • Does the severity of tiptoe walking increase as gastro-soleus muscle shortness increases?

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

May 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

May 21, 2025

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Spinal posture and mobility

    Spinal Mouse : Spinal Mouse is a tool used for noninvasive external evaluation that measures spinal angles and shape in frontal and sagittal planes. It is used to measure spinal intersegmental angles and spinal range of motion. The device is moved over the columna vertebralis on the skin surface following the spinous processes from C7 to S3. It provides information about inclination, thorax, lumbar and sacrum/hip angles. Stores data and provides result output via computer program Both frontal and sagittal assesment were made while standing upright For the sagittal assesment there were 3 different evaluation positions * Standing still * Body flexion * Body extension For the frontal assesment there were 3 different evaluation positions * Standing still * Body left lateral flexion * Body right lateral flexion

    6 Months

Secondary Outcomes (5)

  • Childhood Autism Rating Scale

    6 Months

  • Pediatric Berg Balance Scale

    6 Months

  • Timed Up and Go Test

    6 Months

  • M.Gastrocnemius - M.Gastrosoleus Shortness Measurement

    6 Months

  • Classification of Tiptoe Walking

    6 Months

Study Arms (2)

Typically Developing Children

This group consists of typically developing children.

Children With Autism

This group consists of children who have been diagnosed with autism based on "Special Needs Report for Children" (ÇÖZGER) report.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study includes children with autism and typically developing children between the ages of 6-18

You may qualify if:

  • Being diagnosed with autism spectrum disorder in the Special Needs Report for Children (ÇÖZGER)
  • GMFCS level I or II
  • Between the ages of 6-18
  • IQ score of 50 or more as determined in the Special Needs Report for Children (ÇÖZGER)
  • Volunteering to participate in the study

You may not qualify if:

  • Having a rigid contracture of the columna vertebralis
  • Having undergone scoliosis surgery
  • Having a rigid contracture in passive knee extension and ankle range of motion
  • History of surgery or botox affecting ankle joint range of motion in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bolu Abant İzzet Baysal University

Bolu, Bolu, 14030, Turkey (Türkiye)

Location

Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi

Düzce, Düzce, 81100, Turkey (Türkiye)

Location

Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi

Ereğli, Zonguldak Province, 67300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Seda Ayaz Taş, Phd

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr.

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 29, 2025

Study Start

June 15, 2025

Primary Completion

December 15, 2025

Study Completion

February 25, 2026

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations