Correlation Between Balance and Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pediatric balance scale.
Sponsored by
About this trial
This is an interventional diagnostic trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusive criteria:
- Children age ranged from 60 months to 84 months.
- They were divided into two groups (control and study groups).
- Study group: Thirty children from both sexes (22 boys and 8 girls) suffering from attention deficit hyperactivity disorder (ADHD) according to the ADHD Rating Scale-I. They had the total percentile scores of ADHD Rating Scale-IV ≥ 93. They had no history of cerebral palsy, epilepsy or head trauma.
- Control group: Thirty typically developed children from both sexes (20 boys and 10 girls). They had the total percentile scores of ADHD Rating Scale-IV ≤ 50.
Exclusive criteria:
- They had no history of cerebral palsy, epilepsy or head trauma.
- They had no auditory or visual disorders.
- They had no mental retardation.
Sites / Locations
- several kindergartens at Cairo, Egypt
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pediatric balance scale
Arm Description
The Pediatric Balance Scale (PBS) includes fourteen items. Each item of subsets scored as 4, 3, 2, 1 or 0. Finally, the total test score was calculated
Outcomes
Primary Outcome Measures
Pediatric Balance Scale (PBS) scoring for the children suffering from ADHD
The Pediatric Balance Scale (PBS) includes fourteen items.
correlation between the pediatric balance scale scores and the gender, age and ADHD rating scale-IV for the study group
The Bivariate Correlations procedure computed Pearson- a parametric test, to test the relationship between Pediatric Balance Scale (PBS) score and the total percentile scores of ADHD Rating Scale-IV variables with ordered categories and their significance levels.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03949413
Brief Title
Correlation Between Balance and Attention in Children With Attention Deficit Hyperactivity Disorder
Acronym
ADHD
Official Title
Correlation Between Balance and Attention in Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amira Hussin Hussin Mohammed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objective: The present study aimed to determine balance in children with attention deficit hyperactivity disorder compared to normal peers. Also, it investigated the correlation between their balance and the total percentile scores of ADHD Rating Scale-IV.
Design: Cross sectional design. Methods: Sixty children participated in this study from both sexes (42 boys and 18 girls) with age ranged from 60 to 84 months. They were divided into two groups based on the ADHD Rating Scale-IV. Control group: 30 typically developed children from both sexes (20 boys and 10 girls) with mean age 67.53 ± 1.41 months. They had the total percentile scores of ADHD Rating Scale-IV ≤ 50. Study group: 30 children from both sexes (22 boys and 8 girls) suffering from attention deficit hyperactivity disorder (ADHD) with mean age 68.60 ± 4.62 months. They had the total percentile scores of ADHD Rating Scale-IV ≥ 93. Both groups were assessed for their balance by Pediatric Balance Scale (PBS).
Detailed Description
This study was conducted to compare balance in children with attention deficit hyperactivity disorder to normal peers. Also, it aimed to explore the relation between the attention and balance in the children suffering from ADHD. The age of the children included in this study ranged from five to seven years old because it was reported that ADHD is estimated to affect between 3% and 5% of children of primary school age. The result of this study showed that there was no significant differences between the mean values of the age for both control and study groups which supported there was matching between control and study groups. Also, the results represented that boys were suffering from ADHD more than girls. Both groups were assessed by Pediatric balance scale (PBS) which is reliable measure of balance used with child with motor impairment.
Also, the results of this study represented significant difference in Pediatric Balance Scale (PBS) scores in the study group (ADHD group) as compared to the control group (typically developed children group) which indicated that there was balance disturbance in children suffering from ADHD. The Pediatric balance scale scores (PBS) in the children with ADHD is lower than the typically development children by 19.42 % and 16.28% for males and females respectively. These findings come in agreement with Kim et al., who reported that the children with ADHD had disturbance of balance. Also, it was confirmed by Mao et al., who suggest that balance ability skill levels in children with ADHD were generally not as high as those of the controls in various aspects, including static and dynamic balance. It was reported that children with ADHD were showed posture and gait performance abnormalities, particularly in the movement coordination test and paced stepping task.
Also, the results of this study represent there was significant negative relationship between the Pediatric balance scale score and the percentile scores of ADHD Rating Scale-IV in the study group. This finding indicates that the disturbance of the balance in the children suffering from ADHD was inversely proportional to their percentile scores of ADHD. This finding comes in agreement with Abuin-Porras et al., who stated that there was a significant relationship between attention and balance and gender differences that may condition the way to address balance issues in boys and girls.
The disturbance of balance in the children suffering from ADHD can be referred to decrease in the volume of cerebrum and cerebellum in the children suffering from ADHD as compared to the healthy children. Also, there was cerebellum dysfunction in the children suffering from ADHD due to the decrease in the brain conductivity from cerebellum to the middle frontal and medial frontal gyri in those children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pediatric balance scale
Arm Type
Experimental
Arm Description
The Pediatric Balance Scale (PBS) includes fourteen items. Each item of subsets scored as 4, 3, 2, 1 or 0. Finally, the total test score was calculated
Intervention Type
Diagnostic Test
Intervention Name(s)
Pediatric balance scale.
Other Intervention Name(s)
ADHD Rating Scale-IV
Intervention Description
The Pediatric Balance Scale (PBS) includes fourteen items. Each item of subsets scored as 4, 3, 2, 1 or 0. Finally, the total test score was calculated.
Each child in both groups was examined individually, using ADHD Rating Scale-IV checklist. The child's teacher was asked to write the checklist. Then the therapist interpreted the total scores obtained from the checklist and she converted it to the percentile scores based on their total scores.
Primary Outcome Measure Information:
Title
Pediatric Balance Scale (PBS) scoring for the children suffering from ADHD
Description
The Pediatric Balance Scale (PBS) includes fourteen items.
Time Frame
20 weeks
Title
correlation between the pediatric balance scale scores and the gender, age and ADHD rating scale-IV for the study group
Description
The Bivariate Correlations procedure computed Pearson- a parametric test, to test the relationship between Pediatric Balance Scale (PBS) score and the total percentile scores of ADHD Rating Scale-IV variables with ordered categories and their significance levels.
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Months
Maximum Age & Unit of Time
84 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusive criteria:
Children age ranged from 60 months to 84 months.
They were divided into two groups (control and study groups).
Study group: Thirty children from both sexes (22 boys and 8 girls) suffering from attention deficit hyperactivity disorder (ADHD) according to the ADHD Rating Scale-I. They had the total percentile scores of ADHD Rating Scale-IV ≥ 93. They had no history of cerebral palsy, epilepsy or head trauma.
Control group: Thirty typically developed children from both sexes (20 boys and 10 girls). They had the total percentile scores of ADHD Rating Scale-IV ≤ 50.
Exclusive criteria:
They had no history of cerebral palsy, epilepsy or head trauma.
They had no auditory or visual disorders.
They had no mental retardation.
Facility Information:
Facility Name
several kindergartens at Cairo, Egypt
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Correlation Between Balance and Attention in Children With Attention Deficit Hyperactivity Disorder
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