Correlation Between Balance and Attention in Children Wit... | NCT03949413

Studies
Correlation Between Balance and Attention in Children With Attention Deficit Hyperactivity Disorder

NCT03949413

Sponsor

Delta University for Science and Technology

Status

Completed

Last Update Posted

Feb 22, 2024Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Attention Deficit Disorder

Interventions

Not provided

Countries

Egypt

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Apr 28, 2019Actual

Completion Date

May 28, 2019Actual

First Submitted Date

May 8, 2019

First Submission Date that Met QC Criteria

May 10, 2019

First Posted Date

May 14, 2019Actual

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

Feb 19, 2024

Last Update Posted Date

Feb 22, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amira Hussin Hussin Mohammed, Lecturer in Department of Physical Therapy for Pediatric Disorders, Faculty of Physical Therapy, Delta University for Science and TechnologyPrincipal Investigator

Lead Sponsor

Delta University for Science and TechnologyOTHER

Collaborators

Not provided

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

Objective: The purpose of the current study was to investigate balance in children with attention deficit hyperactivity disorder compared to normal subjects. Furthermore, it studied the relationship between their balance and the total percentile scores of the ADHD Rating Scale IV.

Detailed Description

Objective: The purpose of the current study was to investigate balance in children with attention deficit hyperactivity disorder contrasted to normal subjects. Furthermore, it studied the relationship between their balance and the total percentile scores of ADHD Rating Scale-IV.

Design: The study was a cross-sectional design. Methods: Sixty children were involved in this research from both sexes (42 boys and 18 girls) with age ranged from 60 to 84 months. They were subdivided into two groups based on the ADHD Rating Scale-IV. The control group included 30 normally developed children from both sexes (20 boys and 10 girls) with a mean age of 67.53 ± 1.41 months, and the total percentile scores of ADHD Rating Scale-IV ≤ 50. The study group comprised of 30 children from both sexes (22 boys and 8 girls) with attention deficit hyperactivity disorder (ADHD) with a mean age of 68.60 ± 4.62 months. The total percentile scores of ADHD Rating ScaleIV were ≥ 93. Both groups were investigated for their balance by Pediatric Balance Scale (PBS).

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group (A)		30 normal children
study Group (B)		30 children from both sexes (22 boys and 8 girls) with attention deficit hyperactivity disorder (ADHD)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ADHD Rating Scale-IV checklist, school version	Both groups were investigated by the ADHD Rating Scale-IV checklist, school version to know if the child was diagnosed with ADHD or rule out.	At the baseline evaluation.
Pediatric Balance Scale (PBS)	Both groups were assessed for their balance by PBS	At the baseline evaluation.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Sixty children were involved in the present research from both sexes (42 boys and 18 girls) which were subdivided into two equal groups (control and study groups). They were recruited from different kindergartens at Cairo, Egypt, based on the following criteria:

inclusive criteria:

age ranged from 60 to 84 months.
selected from both sex.
Children in the study group with attention deficit hyperactivity disorder (ADHD) based on the ADHD Rating Scale-I with total percentile scores ≥ 93, Children in control group normally developed with total percentile scores of ADHD Rating Scale-IV ≤ 50.

exclusive criteria:

- no history of cerebral palsy, epilepsy or head trauma.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Months

Maximum Age

84 Months

Standard Ages

Child

Study Population

Sixty children were involved in the present research from both sexes (42 boys and 18 girls) with age ranged from 60 to 84 months, which were subdivided into two groups (control and study groups). They were recruited from different kindergartens at Cairo, Egypt

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Kindergartens		Cairo			Egypt
Amira Hussin Mohammed

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided