NCT07163949

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

August 29, 2025

Last Update Submit

September 5, 2025

Conditions

Keywords

Autism Spectrum DisorderBalancefootpostureanthropometry

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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.

    Baseline

Secondary Outcomes (3)

  • Foot-Ankle Anthropometric Measurements

    Baseline

  • Foot Muscle Strength

    Baseline

  • Tandem Walking Test

    Baseline

Study Arms (1)

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).

Other: Performance-based tests (such as TUG, foot posture measurements, Tandem Gait test) will be administered to children with ASD.

Interventions

Children with ASD underwent balance and foot measurement tests that they could perform only by following instructions.

Autism Spectrum Disorder

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study included individuals aged 5-18 with a diagnosis of Autism Spectrum Disorder

You may qualify if:

  • Aged 5-18.
  • Clinical diagnosis of ASD.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (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.

  • 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.

MeSH Terms

Conditions

Autistic DisorderFoot Deformities, CongenitalAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersFoot DeformitiesMusculoskeletal DiseasesLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Prof

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 9, 2025

Study Start

September 15, 2024

Primary Completion

January 15, 2025

Study Completion

June 15, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations