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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05522478
• Other study ID #: Gulcan Ozturk
• Status: Completed
• Start date: July 2016
• Est. completion date: January 2017

Study information

• Verified date: August 2022
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
Turkey	Gulcan Ozturk	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postural control	Postural stability tests, including overall stability index (OSI), anterior-posterior stability index (APSI), and medial-lateral stability index (MLSI)	one year
Primary	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
Primary	Fall risk	Fall risk score was calculated by Biodex balance system	one year