Attention Deficit DisorderNCT03949413
Correlation Between Balance and Attention in Children With Attention Deficit Hyperactivity Disorder
An observational study of Attention Deficit Disorder, run by Delta University for Science and Technology at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 84 monthsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2019to 28 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 84 months
- All sexes
- Healthy volunteers accepted
- 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
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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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).
- Conditions
- Attention Deficit Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the baseline evaluation.
Pediatric Balance Scale (PBS)
Both groups were assessed for their balance by PBS
Measured: At the baseline evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Feb 2019
- Primary completion28 Apr 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949413
- Sponsor's protocol ID
- DeltaUPT1
- Status last verified
- Feb 2024
- First submitted
- 8 May 2019
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Balance and Attention in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03949413
- Acronym / sponsor ID
- DeltaUPT1
- Conditions
- Attention Deficit Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Apr 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 60 to 84 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ADHD Rating Scale-IV checklist, school version
Time frame: At the baseline evaluation.
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.
Pediatric Balance Scale (PBS)
Time frame: At the baseline evaluation.
Both groups were assessed for their balance by PBS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder, run by Delta University for Science and Technology at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Rating Scale-IV checklist, school version (time frame: At the baseline evaluation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.