NCT03949413

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2019

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

May 8, 2019

Last Update Submit

February 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

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)

Eligibility Criteria

Age60 Months - 84 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Kindergartens

Cairo, Egypt

Location

Amira Hussin Mohammed

Gamasa, 35712, Egypt

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
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Department of Physical Therapy for Pediatric Disorders, Faculty of Physical Therapy

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 14, 2019

Study Start

February 1, 2019

Primary Completion

April 28, 2019

Study Completion

May 28, 2019

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations