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CompletedNCT05522478Updated Jan 5, 2024

Effect Of Methylphenidate On Balance In Children With Attention Deficit Hyperactivity Disorder

An observational study in Attention Deficit Hyperactivity Disorder, sponsored by Fatih Sultan Mehmet Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by Fatih Sultan Mehmet Training and Research Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
85
Ages
8 Years to 12 Years
Sex
All
01

Study summary

Attention Deficit Hyperactivity Disorder is a neurodevelopmental disorder that may have poor motor coordination and balance control. The effect of Methylphenidate treatment on balance and fall risk is still unclear. This study aimed to evaluate the effect of methylphenidate (MPH) treatment on balance, fall risk, and sensorimotor integration in children with Attention Deficit Hyperactivity Disorder (ADHD).

Read the detailed description

Children who were diagnosed with ADHD for the first time were classified in the ADHD group (n=33), children with ADHD who were treated with MPH for a minimum of 3 months were classified in the treatment group (n=32), and typically developing children were classified in the third-the control group (n=20) in this observational cross-sectional study. Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.Postural stability tests, including overall stability index (OSI), anterior-posterior stability index (APSI), and medial-lateral stability index (MLSI), were used to evaluate postural control. The Modified Clinical Test of Sensory Interaction in Balance (m-CTSIB) testing protocol was used to evaluate sensory integration capabilities and balance. Fall risk was evaluated by biodex balance system.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder

Keywords

  • Attention Deficit Hyperactivity Disorder
  • Methylphenidate
  • Postural Balance
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 85 is below the median of 134 across 122 observational studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital is the lead sponsor of 118 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All children who were diagnosed with ADHD for the first time according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V, American Psychiatric Association, 2013) were classified in the ADHD group (n=33), children with ADHD who were treated with MPH for a minimum of 3 months and were followed-up at our clinic were classified in the treatment group (n=32), and typically developing children were classified in the third-the control group (n=20) in this observational cross-sectional study.

Inclusion criteria

  • Children who were diagnosed with ADHD for the first time according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V, American Psychiatric Association, 2013)

Exclusion criteria

Exclusion Criteria:

  • neurological disorders
  • psychiatric disorders
  • musculoskeletal disorders
  • cardiopulmonary diseases
  • visual impairments
  • developmental coordination disorders that could affect balance
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
85 participants (actual)
Patient registry
No

Groups and cohorts

  • ADHD group

    Children who were diagnosed with ADHD for the first time were classified in the ADHD group (n=33)

    Device: Fall risk

  • treatment group

    children with ADHD who were treated with MPH for a minimum of 3 months were classified in the treatment group (n=32)

    Device: Fall risk

  • control group

    typically developing children were classified in the third-the control group (n=20)

    Device: Fall risk

Interventions

  • DeviceFall risk

    Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.

    Also known as: static postural balance, sensorimotor integration (m-CTSIB) test

06

What researchers measure

Primary outcomes

  1. postural control

    Postural stability tests, including overall stability index (OSI), anterior-posterior stability index (APSI), and medial-lateral stability index (MLSI)

    Time frame: one year

  2. sensorimotor integration

    The Modified Clinical Test of Sensory Interaction in Balance (m-CTSIB) testing protocol was used to evaluate sensory integration capabilities and balance. Four different conditions were evaluated for the m-CTSIB test protocol: Eyes Open Firm Surface (EOFS), Eyes Closed Firm Surface (ECFS), Eyes Open Soft Surface (EOSS), and Eyes Closed Soft Surface (ECSS)

    Time frame: one year

  3. Fall risk

    Fall risk score was calculated by Biodex balance system

    Time frame: one year

07

Study locations

1 site
  • Gulcan Ozturk
    Istanbul, 34752, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05522478
Lead sponsor
Fatih Sultan Mehmet Training and Research Hospital
Responsible party
Sponsor
First posted
Aug 31, 2022
Start date
Jul 2016
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jan 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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