Autism DisorderNCT07163949
Balance And Foot Posture In Children With Autism Spectrum Disorder
An observational study of Autism Disorder and Balance, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
The position of the ankle and foot is known as foot posture, and this can have an impact on balance and mobility. Previous research has shown that differences in foot structure and posture between different populations can have a significant impact on balance. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Autism Disorder, Balance, Posture
- What is being tested?
- Performance-based tests (such as TUG, foot posture measurements, Tandem Gait test) will be administered to children with ASD.
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 15 Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study included individuals aged 5-18 with a diagnosis of Autism Spectrum Disorder
Who may be able to join
- Aged 5-18.
- Clinical diagnosis of ASD.
Who cannot join
- Lack of parental consent;
- Use of assistive devices;
- Presence of vision or hearing loss;
- Use of medications known to impair motor function, such as antipsychotics, stimulants or anticonvulsants;
- Having undergone any lower extremity injury or surgery in the past six months;
- Not being able to follow the commands necessary to obtain the study data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balance In Children With Autism Spectrum Disorder: The Role Of Foot Posture And Anthropometry
The position of the ankle and foot is known as foot posture, and this can have an impact on balance and mobility. Previous research has shown that differences in foot structure and posture between different populations can have a significant impact on balance. However, to our knowledge, no study has examined the relationship between foot posture, anthropometry, muscle strength, and balance in children with Autism Spectrum Disorder. This study was therefore designed to analyse these relationships.
- Conditions
- Autism Disorder, Balance, Posture, Foot Anomalies
- Being tested
- Performance-based tests (such as TUG, foot posture measurements, Tandem Gait test) will be administered to children with ASD.
- Keywords
- Autism Spectrum Disorder, Balance, foot, posture, anthropometry
- Medical subject headings
- Autistic Disorder, Foot Deformities, Congenital, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance-based tests (such as TUG, foot posture measurements, Tandem Gait test) will be administered to children with ASD.Other
Children with ASD underwent balance and foot measurement tests that they could perform only by following instructions.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Autism spectrum disorders (ASD) are complex neurodevelopmental conditions characterised by deficits in communication and reciprocal social interactions, as well as restricted interests and repetitive behaviours. Although motor impairments have been recognised as limiting daily motor skills, they are not included in the DSM-5 diagnostic criteria for ASD. The Centers for Disease Control and Prevention published an estimate that the prevalence of ASD in the US population was approximately 1 in 54 eight-year-old children (around 1.85% of the child population). Furthermore, the World Health Organization (WHO) documented a worldwide prevalence of approximately 0.76% in 2010 (affecting nearly 1.16% of the entire child population). Receives: Other: Performance-based tests (such as TUG, foot posture measurements, Tandem Gait test) will be administered to children with ASD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Posture Assessment
Foot Posture Assessment: Children's foot posture will be assessed using the Foot Posture Index (FPI-6), which is valid for pediatric individuals. The Foot Posture Index is a scale consisting of a total of 6 items related to the posture of the rear foot and forefoot. These items are talar head palpation, the position of the inclinations above and below the lateral malleolus, the position of the calcaneus, ballooning in the talonavicular joint region, the structure of the medial longitudinal arch, and the abduction/adduction of the forefoot relative to the rearfoot. The total score in this assessment tool ranges from -12 to 12.
Measured: Baseline
Timed Up and Go (TUG) test
Timed Up and Go (TUG) test: For this test, individuals are seated in a chair. The individual is asked to stand up from the chair without assistance, walk three meters on the marked floor, walk back to the chair, and sit down again. The stopwatch is started with the "start" command and stopped when the individual sits down. The TUG time is recorded in seconds (s).
Measured: Baseline
One-Leg Standing Test
One-Leg Standing Test: During this test, which is used to assess an individual's static balance, the subject will be asked to lift one leg without touching the supporting leg, keeping their eyes open, and the time spent on one leg will be recorded in seconds.
Measured: Baseline
Secondary outcomes (3)
Foot-Ankle Anthropometric Measurements
Foot-Ankle Anthropometric Measurements: For the foot-ankle anthropometry of patients, foot length (cm), metatarsal width (cm), and navicular drop height (cm) will be assessed with and without body weight applied to the foot.
Measured: Baseline
Foot Muscle Strength
Foot Muscle Strength: Foot plantar flexion and dorsiflexion muscle strength will be assessed using a digital hand dynamometer.
Measured: Baseline
Tandem Walking Test
Tandem Walking Test: The tandem walking test is used to assess dynamic balance. The subject will be asked to walk along a line drawn on the floor, with the heel of one foot touching the toe of the other foot. The duration of the tandem walk will be measured for each walk, consisting of 10 steps. If balance is lost and the participant is unable to complete 10 steps, the number of steps taken and the duration will be recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Sep 2024
- Primary completion15 Jan 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güllü Aydın Yağcıoğlu, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163949
- Sponsor's protocol ID
- AFB
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fournier KA, Kimberg CI, Radonovich KJ, Tillman MD, Chow JW, Lewis MH, Bodfish JW, Hass CJ. Decreased static and dynamic postural control in children with autism spectrum disorders. Gait Posture. 2010 May;32(1):6-9. doi: 10.1016/j.gaitpost.2010.02.007. Epub 2010 Apr 18.
PubMed 20400311Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.
PubMed 30078460
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance In Children With Autism Spectrum Disorder: The Role Of Foot Posture And Anthropometry
- ClinicalTrials.gov ID
- NCT07163949
- Acronym / sponsor ID
- AFB
- Conditions
- Autism Disorder, Balance, Posture, Foot Anomalies
- Keywords
- Autism Spectrum Disorder, Balance, foot, posture, anthropometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 9 Sep 2025 (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 position of the ankle and foot is known as foot posture, and this can have an impact on balance and mobility. Previous research has shown that differences in foot structure and posture between different populations can have a significant impact on balance. However, to our knowledge, no study has examined the relationship between foot posture, anthropometry, muscle strength, and balance in children with Autism Spectrum Disorder. This study was therefore designed to analyse these relationships.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | – | Other: Performance-based tests (such as TUG, foot posture measurements, Tandem Gait test) will be administered to children with ASD.Autism spectrum disorders (ASD) are complex neurodevelopmental conditions characterised by deficits in communication and reciprocal social interactions, as well as restricted interests and repetitive behaviours. Although motor impairments have been recognised as limiting daily motor skills, they are not included in the DSM-5 diagnostic criteria for ASD. The Centers for Disease Control and Prevention published an estimate that the prevalence of ASD in the US population was approximately 1 in 54 eight-year-old children (around 1.85% of the child population). Furthermore, the World Health Organization (WHO) documented a worldwide prevalence of approximately 0.76% in 2010 (affecting nearly 1.16% of the entire child population). |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study included individuals aged 5-18 with a diagnosis of Autism Spectrum Disorder
Key inclusion criteria (2 listed)
- Aged 5-18.
- Clinical diagnosis of ASD.
Key exclusion criteria (6 listed)
- Lack of parental consent;
- Use of assistive devices;
- Presence of vision or hearing loss;
- Use of medications known to impair motor function, such as antipsychotics, stimulants or anticonvulsants;
- Having undergone any lower extremity injury or 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 |
|---|---|---|
| Performance-based tests (such as TUG, foot posture measurements, Tandem Gait test) will be administered to children with ASD.Children with ASD underwent balance and foot measurement tests that they could perform only by following instructions. | Other | Autism Spectrum Disorder |
Primary outcome
Foot Posture Assessment
Time frame: Baseline
Foot Posture Assessment: Children's foot posture will be assessed using the Foot Posture Index (FPI-6), which is valid for pediatric individuals. The Foot Posture Index is a scale consisting of a total of 6 items related to the posture of the rear foot and forefoot. These items are talar head palpation, the position of the inclinations above and below the lateral malleolus, the position of the calcaneus, ballooning in the talonavicular joint region, the structure of the medial longitudinal arch, and the abduction/adduction of the forefoot relative to the rearfoot. The total score in this assessment tool ranges from -12 to 12.
Timed Up and Go (TUG) test
Time frame: Baseline
Timed Up and Go (TUG) test: For this test, individuals are seated in a chair. The individual is asked to stand up from the chair without assistance, walk three meters on the marked floor, walk back to the chair, and sit down again. The stopwatch is started with the "start" command and stopped when the individual sits down. The TUG time is recorded in seconds (s).
One-Leg Standing Test
Time frame: Baseline
One-Leg Standing Test: During this test, which is used to assess an individual's static balance, the subject will be asked to lift one leg without touching the supporting leg, keeping their eyes open, and the time spent on one leg will be recorded in seconds.
3 secondary outcomes
Foot-Ankle Anthropometric Measurements
Time frame: Baseline
Foot Muscle Strength
Time frame: Baseline
Tandem Walking Test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publication: PubMed 20400311Fournier KA, Kimberg CI, Radonovich KJ, Tillman MD, Chow JW, Lewis MH, Bodfish JW, Hass CJ. Decreased static and dynamic postural control in children with autism spectrum disorders. Gait Posture. 2010 May;32(1):6-9. doi: 10.1016/j.gaitpost.2010.02.007. Epub 2010 Apr 18.
- Results publication: PubMed 30078460Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Disorder and Balance, run by Gulhane School of Medicine 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 9 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Posture Assessment (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163949, which also lists 2 linked publications.
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 9 Sep 2025.