Motor Performance in Children With Attention Deficit Hype... | NCT05897437

Studies
Motor Performance in Children With Attention Deficit Hyperactivity Disorder

NCT05897437

Sponsor

Akdeniz University

Status

Unknown status

Last Update Posted

Jul 6, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2023Estimated

Primary Completion Date

Sep 3, 2023Estimated

Completion Date

Sep 16, 2023Estimated

First Submitted Date

Jun 1, 2023

First Submission Date that Met QC Criteria

Jun 1, 2023

First Posted Date

Jun 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2023

Last Update Posted Date

Jul 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children. Children with ADHD have difficulties with co-contraction, producing muscle force, and regulating movement velocity, and physical fitness. The purpose of this study was to compare the gross and fine motor abilities in children with ADHD and children with typical development.

Detailed Description

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children worldwide with a prevalence of 2.6-4.5% between the ages of 6 and 18 years. When compared to children with typical development, children with ADHD have lower scores in 9-12% of gross motor abilities, 9-36% of balance and postural control, 9-19% of fine motor abilities, and 19-22 % of manual and body coordination. Furthermore, children with ADHD have difficulties with co-contraction, producing muscle force, and regulating movement velocity, and physical fitness. As a consequence of the core symptoms of ADHD, such as inattention, impulsivity, and hyperactivity, over 30-50% of children with ADHD may have impaired motor ability. The purpose of this study was to compare the gross and fine motor abilities in children with ADHD and children with typical development.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADHD group		Children with ADHD
Control Group		Typically developing children

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Motor Proficiency	The Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) was used for the evaluation of gross and fine motor skills	One day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of children with attention deficit hyperactivity disorder
aged at 6 -15 years old
able to understand and accept verbal instructions.

Exclusion Criteria:

Clinical diagnosis of children with another psychiatric including autism spectrum disorder, psychotic symptoms, depression
Clinical diagnosis of children with neurological disorder including cerebral palsy, epilepsy, or speech impairments
the parents declined to participate in the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

The children with ADHD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ishak Isık, Prof. Dr.	Contact	02422494400		etik.kurul.07@gmail.com
Ozgun Kaya Kara, Assoc. Prof.	Contact			ozgun_kaya@yahoo.com

Overall Officials

Name	Affiliation	Role
Ozgun Kaya Kara, Assoc. Prof.	Akdeniz University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akdeniz University		Antalya			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25649325	Background	Polanczyk GV, Salum GA, Sugaya LS, Caye A, Rohde LA. Annual research review: A meta-analysis of the worldwide prevalence of mental disorders in children and adolescents. J Child Psychol Psychiatry. 2015 Mar;56(3):345-65. doi: 10.1111/jcpp.12381. Epub 2015 Feb 3.
22940157	Background	Goulardins JB, Marques JC, Casella EB, Nascimento RO, Oliveira JA. Motor profile of children with attention deficit hyperactivity disorder, combined type. Res Dev Disabil. 2013 Jan;34(1):40-5. doi: 10.1016/j.ridd.2012.07.014. Epub 2012 Aug 30.

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders