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

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Device: Fall risk

• Registration Number: NCT05522478
• Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

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).

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 Timeline

• Study Start: 2016-07
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Last Update Submitted: 2023-12-31
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ADHD group	Fall risk	Children who were diagnosed with ADHD for the first time were classified in the ADHD group (n=33)
treatment group	Fall risk	children with ADHD who were treated with MPH for a minimum of 3 months were classified in the treatment group (n=32)
control group	Fall risk	typically developing children were classified in the third-the control group (n=20)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Gulcan Ozturk; 🇹🇷 Istanbul, Turkey