NCT07159113

Brief Summary

The aim of this study was to investigate the relationship between sensory profile and ankle muscle shortness in children with autism. This study will feature only one group consisting of children with autism Childhood autism assessment scale will be completed with the families of the children included in the study. The tip-toe walking status of the children participating in the study will be observed and classified according to the tip-toe walking classification. The ankle muscle shortness of the children will be evaluated by Gastro-Soleus shortness measurements and sensory processing skills will be evaluated by Sensory profile. Muscle shortness measurements and sensory profile results will be compared.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Oct 2025Jun 2026

First Submitted

Initial submission to the registry

May 21, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2026

Expected
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

May 21, 2025

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensory Profile

    This test is used to assess how children aged 3-10 years process information from their body and environment. It is a five-point Likert-type parent questionnaire and consists of 125 items. It is explained to the caregiver that he/she should check the box that best describes how often the child performs the behaviors given in the questionnaire and answer for all parameters; if he/she cannot answer because there is a behavior that he/she cannot observe at all or that he/she thinks does not fit the child, he/she should put an X on that question. The end of each section is scored according "always" 1, "frequently" 2, "occasionally" 3, "rarely" 4, "never" 5. The scores obtained from each parameter are calculated according to the Dunn Sensory Profile Score Explanation and the child is classified according to the categories of 'definite difference', 'probable difference', 'typical performance' from each section.

    One year

Secondary Outcomes (3)

  • Childhood Autism Rating Scale

    One year

  • M.Gastrocnemius - M.Gastrosoleus Shortness Measurement

    One year

  • Classification of Tiptoe Walking

    One year

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study includes children with autism between the ages of 4-10

You may qualify if:

  • Being diagnosed with autism spectrum disorder in the Special Needs Report for Children (ÇÖZGER)
  • GMFCS level I,II or III
  • Between the ages of 4-10
  • Volunteering to participate in the study

You may not qualify if:

  • 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

Central Study Contacts

Seda Ayaz Taş, Phd

CONTACT

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

September 8, 2025

Study Start

October 30, 2025

Primary Completion

February 24, 2026

Study Completion (Estimated)

June 25, 2026

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations