NCT06721104

Brief Summary

The aim of our study is to evaluate temporomandibular joint (TMJ), cervical posture, balance, dual-task performance, and social adaptation skills in individuals with autism. The study will be conducted at Bartın Lider Special Education and Rehabilitation Center following the approval of the ethics committee. Individuals determined by the sample size calculated through power analysis will be included in the study. First, the socio-demographic characteristics (age, height, body weight, body mass index, education level, exercise and smoking habits, etc.) of the participants who voluntarily join the study will be recorded. Participants will be divided into two groups: individuals with typical motor development and those with autism spectrum disorder (ASD), and the same assessment tools will be used for both groups. Individuals with typical motor development will serve as the control group. The assessment tools include the Timed Up and Go (TUG) test, the 10-Meter Walk Test, the Vineland Adaptive Behavior Scale, the PostureScreen Android-based posture assessment application, and the Helkimo Clinical Dysfunction Index for craniomandibular disorders. Based on the evaluation results, the relationships between TMJ, cervical posture, functional balance, dual-task performance, and social adaptation skills in individuals with autism will be analyzed and compared with those of individuals with typical motor development.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 15, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

November 25, 2024

Last Update Submit

December 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cervical Posture Assessment

    Android-based PostureScreen Mobile (version 8.5, developed by Posture CO.inc. USA) application will be used for cervical posture assessment. The application evaluates the static posture of individuals

    At enrollment

Secondary Outcomes (3)

  • Temporomandibular Joint (TMJ) Assessment:

    At enrollment

  • Social Adaptation Assessment:

    At enrollment

  • Functional Balance

    At enrollment

Study Arms (2)

Autism Spectrum Disorder

Other: Dual TaskOther: Functional BalanceOther: Social Adaptation AssessmentOther: Cervical Posture Assessment:Other: Temporomandibular Joint (TMJ) Assessment

Healthy Children

Other: Dual TaskOther: Functional BalanceOther: Social Adaptation AssessmentOther: Cervical Posture Assessment:Other: Temporomandibular Joint (TMJ) Assessment

Interventions

The dual-task abilities of individuals will be assessed by adding motor and cognitive tasks to the 10-Meter Walk Test. The tasks given to participants are as follows: Single Motor Task (comfortable walking): The individual is asked to walk at a normal pace, and the time is recorded. Motor-Motor Dual Task: The individual carries a half-filled water bottle in each hand while walking, and the time is recorded. Motor-Cognitive Dual Task (mental): The individual counts backward from 10 in increments of one while walking, and the time is recorded. Motor-Cognitive Dual Task (memory): The individual is asked to recall three previously mentioned words while walking, and the time is recorded.

Autism Spectrum DisorderHealthy Children

Functional balance will be assessed using the Timed Up and Go (TUG) test. The TUG test measures the time it takes for an individual to stand up from a chair upon the "ready, go" signal, walk a distance of 3 meters, turn around, walk back to the chair, and sit down again. The TUG test is a reliable and sensitive measure of balance and functional mobility in children. At the beginning of the test, participants will be seated on an armless chair with their hips and knees flexed at approximately 90 degrees and their feet flat on the ground. The children will be instructed to stand up from the chair, walk as quickly as possible, touch a target on the wall, walk back, and sit down again.

Autism Spectrum DisorderHealthy Children

Adaptive behavior will be evaluated using the Vineland Adaptive Behavior Scales. This is a parent interview designed to assess functionality in daily life. Specifically, adaptive behavior is evaluated in four domains: Communication, Daily Living Skills, Socialization, and Motor Skills. The Vineland scales are known for their reliability and up-to-date validity. They have been reported to be sensitive to the challenges faced by children with Autism Spectrum Disorder (ASD).

Autism Spectrum DisorderHealthy Children

Cervical posture will be evaluated using the Android-based PostureScreen Mobile application (version 8.5, developed by Posture Co. Inc., USA). This application assesses the static posture of individuals. After determining reference points, the application draws reference lines and records postural deviations. At least two photos of each participant will be taken for the assessment. Participants should not wear clothing items that cover the neck (e.g., scarves, shawls). While the primary focus of the application is to assess postural deviations, it also includes a dental evaluation feature. The validity and reliability of the application have been established in previous studies. In addition to using the application, the posture of individuals will also be evaluated through observational analysis, and the findings will be documented.

Autism Spectrum DisorderHealthy Children

The TMJ will be evaluated using the Helkimo Clinical Craniomandibular Index. This index consists of five subcategories: pain during muscle palpation, pain during TMJ palpation, pain during mandibular functions, TMJ functions (sounds, gliding during maximum opening, dislocation and/or locking), and the mandibular range of motion. Each subcategory is scored as 0, 1, or 5, resulting in a total score ranging from 0 to 25. As this index is based on performance measurements, there is no Turkish validity and reliability study for it. However, a prevalence study using this index was conducted in Turkey by Üner et al. to evaluate its applicability within the Turkish population.

Autism Spectrum DisorderHealthy Children

Eligibility Criteria

Age4 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The assessments will be conducted at the Physical Therapy Unit of the Lider Special Education and Rehabilitation Center, where voluntary families will be contacted and evaluations will be carried out within the rehabilitation center.

You may qualify if:

  • Having a diagnosis of Autism Spectrum Disorder (ASD) confirmed by a physician.
  • Currently enrolled in a special education and rehabilitation center.
  • No vision problems.
  • Ability to understand and follow instructions.
  • No cognitive impairments.
  • No walking difficulties.

You may not qualify if:

  • Individuals with comorbid secondary health conditions.
  • Individuals who have undergone surgery in the past six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale Universty

Kırıkkale, 71450, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderTemporomandibular Joint Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Meral Sertel, Dr.

    Kırıkkale University

    STUDY CHAIR

Central Study Contacts

Alper Gürbüz, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 6, 2024

Study Start

February 15, 2024

Primary Completion

January 1, 2025

Study Completion

May 25, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Locations