- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07163949
- Original Trial
Balance And Foot Posture In Children With Autism Spectrum Disorder
September 5, 2025 updated by: Güllü Aydın Yağcıoğlu, Gulhane School of Medicine
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey (Türkiye), 06018
- University of Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study included individuals aged 5-18 with a diagnosis of Autism Spectrum Disorder
Description
Inclusion Criteria:
- Aged 5-18.
- Clinical diagnosis of ASD.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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).
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Children with ASD underwent balance and foot measurement tests that they could perform only by following instructions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Foot Posture Assessment
Time Frame: Baseline
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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.
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Baseline
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Timed Up and Go (TUG) test
Time Frame: Baseline
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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).
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Baseline
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One-Leg Standing Test
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Foot-Ankle Anthropometric Measurements
Time Frame: Baseline
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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.
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Baseline
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Foot Muscle Strength
Time Frame: Baseline
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Foot Muscle Strength: Foot plantar flexion and dorsiflexion muscle strength will be assessed using a digital hand dynamometer.
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Baseline
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Tandem Walking Test
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lord 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2024
Primary Completion (Actual)
January 15, 2025
Study Completion (Actual)
June 15, 2025
Study Registration Dates
First Submitted
August 29, 2025
First Submitted That Met QC Criteria
September 5, 2025
First Posted (Estimated)
September 9, 2025
Study Record Updates
Last Update Posted (Estimated)
September 9, 2025
Last Update Submitted That Met QC Criteria
September 5, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Mental Disorders
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Autism Spectrum Disorder
- Autistic Disorder
- Foot Deformities, Congenital
Other Study ID Numbers
- AFB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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