Autism Spectrum DisorderNCT06721104
Balance, TMJ, Social Adaptive Assessment in Individuals With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder and Temporomandibular Joint Disorders, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Temporomandibular Joint Disorders, Postural; Defect
- What is being tested?
- Dual Task, Functional Balance and Social Adaptation Assessment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 25 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals with comorbid secondary health conditions.
- Individuals who have undergone surgery in the past six months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırıkkale Universty
Kirikkale, 71450
Simay Tepik Gürbüz, 5456610815, smytepik@gmail.com
About this study
Official title: 'Evaluation of Temporomandibular Joint Dysfunction, Balance, Cervical Posture, Dual Task, and Social Adjustment in Individuals With Autism Spectrum Disorder'
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.
- Being tested
- Dual Task, Functional Balance, Social Adaptation Assessment, Cervical Posture Assessment:, Temporomandibular Joint (TMJ) Assessment
- Medical subject headings
- Autism Spectrum Disorder, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual TaskOther
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.
Functional BalanceOther
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.
Social Adaptation AssessmentOther
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).
Cervical Posture Assessment:Other
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.
Temporomandibular Joint (TMJ) AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Not described Receives: Other: Dual Task; Other: Functional Balance; Other: Social Adaptation Assessment; Other: Cervical Posture Assessment:; Other: Temporomandibular Joint (TMJ) Assessment | |
| Healthy Children | Not described Receives: Other: Dual Task; Other: Functional Balance; Other: Social Adaptation Assessment; Other: Cervical Posture Assessment:; Other: Temporomandibular Joint (TMJ) Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At enrollment
Secondary outcomes (3)
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start15 Feb 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion25 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simay Tepik, Kırıkkale University
- Investigators
- Meral Sertel, Dr., Study chair, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721104
- Sponsor's protocol ID
- S1
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Evaluation of Temporomandibular Joint Dysfunction, Balance, Cervical Posture, Dual Task, and Social Adjustment in Individuals With Autism Spectrum Disorder'
- ClinicalTrials.gov ID
- NCT06721104
- Acronym / sponsor ID
- S1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals with comorbid secondary health conditions.
- Individuals who have undergone surgery in the past six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual TaskThe 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. | Other | Autism Spectrum Disorder, Healthy Children |
| Functional BalanceFunctional 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. | Other | Autism Spectrum Disorder, Healthy Children |
| Social Adaptation AssessmentAdaptive 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). | Other | Autism Spectrum Disorder, Healthy Children |
| Cervical 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. | Other | Autism Spectrum Disorder, Healthy Children |
| Temporomandibular Joint (TMJ) AssessmentThe 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. | Other | Autism Spectrum Disorder, Healthy Children |
Primary outcome
Cervical Posture Assessment
Time frame: At enrollment
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
3 secondary outcomes
Temporomandibular Joint (TMJ) Assessment:
Time frame: At enrollment
Social Adaptation Assessment:
Time frame: At enrollment
Functional Balance
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meral Sertel, Dr. study chair
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Temporomandibular Joint Disorders, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alper Gürbüz, Master (5364014402, alperkemal4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Posture Assessment (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.