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

December 31, 2023 updated by: Fatih Sultan Mehmet Training and Research Hospital

Effect Of Methylphenidate On Static Balance And Fall Risk In Children With Attention Deficit Hyperactivity Disorder: Cross-Sectional Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

85

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

  • Turkey
      • Istanbul, Turkey, 34752
        • Gulcan Ozturk

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

8 years to 12 years (Child)

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.

Description

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:

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

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
ADHD group
Children who were diagnosed with ADHD for the first time were classified in the ADHD group (n=33)
Device: Fall risk
Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.
Other Names:
  • static postural balance
  • sensorimotor integration (m-CTSIB) test
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
Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.
Other Names:
  • static postural balance
  • sensorimotor integration (m-CTSIB) test
control group
typically developing children were classified in the third-the control group (n=20)
Device: Fall risk
Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.
Other Names:
  • static postural balance
  • sensorimotor integration (m-CTSIB) test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postural control
Time Frame: one year
Postural stability tests, including overall stability index (OSI), anterior-posterior stability index (APSI), and medial-lateral stability index (MLSI)
one year
sensorimotor integration
Time Frame: one year
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)
one year
Fall risk
Time Frame: one year
Fall risk score was calculated by Biodex balance system
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

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)

July 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 31, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gulcan Ozturk

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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