NCT05522478

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
Last Updated

January 5, 2024

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 29, 2022

Last Update Submit

December 31, 2023

Conditions

Keywords

Attention Deficit Hyperactivity DisorderMethylphenidatePostural Balance

Outcome Measures

Primary Outcomes (3)

  • postural control

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

    one year

  • 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)

    one year

  • Fall risk

    Fall risk score was calculated by Biodex balance system

    one year

Study Arms (3)

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

Fall riskDEVICE

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
ADHD groupcontrol grouptreatment group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulcan Ozturk

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2022

First Posted

August 31, 2022

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 5, 2024

Record last verified: 2022-08

Locations