ClinicalTrials.gg
RecruitingNCT06721104Updated Dec 6, 2024

Balance, TMJ, Social Adaptive Assessment in Individuals With Autism Spectrum Disorder

An observational study in Autism Spectrum Disorder, Temporomandibular Joint Disorders and Postural; Defect, sponsored by Kırıkkale University. Recruiting at 1 site in Turkey. Open to participants aged 4 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by Kırıkkale University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
23
Ages
4 Years to 21 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 56 studies in Autism Spectrum Disorder with a site in Turkey — 11 open to participants now, 12 under way, none of them phase 3. Autism Spectrum Disorder · Turkey.

Planned enrollment
9th of 10
23 · median 74
Started
2024
with 7 others
Observational
10 of 56
3 open now
Primary completion
2025-01
later than 1 of 11 live
Registered
22nd of 56
by date
Lead sponsor
2 of 56
Kırıkkale University

Among the 56 studies in Autism Spectrum Disorder with a site in Turkey, this one is the 9th largest by planned enrollment of the 10 observational ones that give a count, is one of 8 that started in 2024, is one of 10 observational ones, reaches primary completion later than 1 of the 11 other live ones, and was the 22nd registered.

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

Browse Autism Spectrum Disorder studies →

Open to participants now

11 of the 56 studies in Autism Spectrum Disorder with a site in Turkey are open now. Recruiting first, the newest first:

5 more — sign in →

All 11 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 298 take children under 18; 92 take healthy volunteers.

This study: 4 Years to 21 Years · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 56 studies in Autism Spectrum Disorder with a site in Turkey, or all of them as a file.
02

Study 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.

Read the detailed description

It has been stated in the literature that individuals with autism spectrum disorder have postural control deficiency, but there is no study examining the dual task skills of these individuals and the contribution of these skills to social life.

It has been stated in the literature that bruxism can cause TMJ in individuals with normal development, and there are studies related to TMJ's cervical problems and balance. However, there are no studies explaining the relationship between teeth grinding and dental problems in individuals with ASD, temporomandibular joint problems and cervical posture and balance.

Studies suggest that multi-faceted evaluations be made in individuals with ASD. The aim of our study is to evaluate TMJ dysfunction, cervical posture, functional balance, dual task and social adaptation skills in individuals with ASD. In terms of these evaluations, our study has the feature of a pilot study in the literature.

03

Conditions studied

  • Autism Spectrum Disorder
  • Temporomandibular Joint Disorders
  • Postural; Defect
04

Who can participate

Ages eligible
4 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Individuals with comorbid secondary health conditions.
  • Individuals who have undergone surgery in the past six months.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
23 participants (estimated)
Patient registry
No

Groups and cohorts

  • Autism Spectrum Disorder

    Other: Dual Task · Other: Functional Balance · Other: Social Adaptation Assessment · Other: Cervical Posture Assessment: · Other: Temporomandibular Joint (TMJ) Assessment

  • Healthy Children

    Other: Dual Task · Other: Functional Balance · Other: Social Adaptation Assessment · Other: Cervical Posture Assessment: · Other: Temporomandibular Joint (TMJ) Assessment

Interventions

  • OtherDual Task

    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.

  • OtherFunctional Balance

    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.

  • OtherSocial Adaptation Assessment

    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).

  • OtherCervical Posture Assessment:

    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.

  • OtherTemporomandibular Joint (TMJ) Assessment

    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.

06

What researchers measure

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

    Time frame: At enrollment

Secondary outcomes

  1. Temporomandibular Joint (TMJ) Assessment:

    Helkimo Clinical Craniomandibular Index will be used for TMJ evaluation. This index consists of 5 subsections: pain on muscle palpation, pain on TMJ palpation, pain in mandibular functions, TMJ functions (sound, gliding at maximum extension, luxation and/or locking) and the capacity of mandibular movement.

    Time frame: At enrollment

  2. Social Adaptation Assessment:

    Adaptive behavior will be assessed with the Vineland Adaptive Behavior Scales. It is a parent interview designed to assess functioning in daily life.

    Time frame: At enrollment

  3. Functional Balance

    It will be assessed with the TUG test. The TUG ready measures the time it takes for an individual to get up from a chair, walk a distance of 3 meters, turn around, walk back to the chair and sit down again after the start signal.

    Time frame: At enrollment

07

Study locations

1 of 1 sites recruiting
  • Kırıkkale Universty
    Kırıkkale, 71450, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Jan 2025, 10 months after the start.

Of 98 non-industry observational studies under Autism Spectrum Disorder, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 120. This study's planned 10 months is below that.

Counting every sponsor, half of 112 studies reached it within 40 months; a quarter within 26 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2024
First posted
Dec 6, 2024
StartActual
Feb 15, 2024
Primary completionEst.
Jan 1, 2025
CompletionEst.
May 25, 2025
Last update
Dec 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06721104
Responsible party
Simay Tepik (Principal Investigator, Kırıkkale University) — Principal investigator
First posted
Dec 6, 2024
Start date
Feb 15, 2024
Primary completion
Jan 1, 2025 (estimated)
Completion
May 25, 2025 (estimated)
Last update
Dec 6, 2024

Study contacts

Alper Gürbüz, Master
Contact
alperkemal4@gmail.com
5364014402
Meral Sertel, Dr.
study chair · Kırıkkale University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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