NCT07180758

Brief Summary

The aim of this study is to investigate the potential of postural control and plantar pressure data in predicting Attention Deficit Hyperactivity Disorder (ADHD) in middle school students using machine learning methods. A total of 100 students will participate, including those identified with symptoms of ADHD and healthy controls. Participants will undergo non-invasive biomechanical assessments, including pedobarographic foot pressure measurement and mobile posture analysis. Behavioral data will be collected using DSM-IV-based rating scales developed by Atilla Turgay, completed separately by parents, teachers, and caregivers. All data will be used to develop predictive models using algorithms such as random forest, logistic regression, and support vector machines. The study is observational and cross-sectional.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 9, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

July 7, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

Attention Deficit Disorder with HyperactivityArtificial IntelligencePostureMachine Learningchild

Outcome Measures

Primary Outcomes (1)

  • Prediction of ADHD Diagnosis Using Biomechanical and Postural Parameters

    Diagnostic accuracy (sensitivity, specificity, overall accuracy, AUC) of a machine learning model developed using postural, balance, pedobarographic, and anthropometric parameters will be evaluated in distinguishing ADHD and control children.

    Baseline (Single assessment session)

Secondary Outcomes (13)

  • Postural Assessment via Mobile Posture App

    Baseline

  • Postural Assessment - New York Posture Rating Test (NYPRT)

    Baseline

  • Plantar Pressure Distribution

    Baseline

  • Foot Posture Assessment - Foot Posture Index (FPI-6) Total Score

    Baseline

  • Sway Path Length

    Baseline

  • +8 more secondary outcomes

Study Arms (2)

ADHD Group

This group includes children aged 10-14 years who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) based on DSM-IV criteria. Parent and teacher rating scales developed by Atilla Turgay will be used to assess ADHD symptom severity. Participants will undergo a comprehensive evaluation including postural assessment, foot posture analysis, balance measurement, pedobarographic and stabilometric pressure analysis, and physical activity assessment using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Based on the data obtained from these assessments, an artificial intelligence (AI)-supported predictive model will be developed to estimate ADHD-related patterns and distinguish ADHD profiles from healthy controls.

Healthy Control Group

This group includes age- and gender-matched children (10-14 years old) without a diagnosis of ADHD or other neurodevelopmental/psychiatric disorders. The same battery of physical assessments-postural, foot posture, balance, pedobarographic and stabilometric measurements, and physical activity assessment using the International Physical Activity Questionnaire - Short Form (IPAQ-SF)-will be conducted. These data will be used in conjunction with the ADHD group to develop and validate the AI-based predictive model.

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 10 to 14 years, including both those diagnosed with ADHD and healthy peers, attending a middle school in the Eyüpsultan district. Participants will be selected based on their eligibility criteria and categorized accordingly.

You may qualify if:

  • Students attending a middle school located in Eyüpsultan district
  • Informed consent obtained from their parents
  • Students enrolled in full-time education
  • Children with age-appropriate motor development skills.

You may not qualify if:

  • Children who have undergone orthopedic interventions due to lower extremity or spinal deformities
  • Children with congenital or acquired neuromuscular disorders
  • Children with significant visual or auditory impairments
  • Children with systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University, Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Öykü Ak, MSc Candidate

    Biruni University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Güzin Kaya Aytutuldu, Asst prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 7, 2025

First Posted

September 18, 2025

Study Start

May 9, 2025

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations