Attention Deficit Hyperactivity DisorderNCT05897437
Motor Performance in Children With Attention Deficit Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2023to 16 Sep 2023
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The children with ADHD
Who may be able to join
- Clinical diagnosis of children with attention deficit hyperactivity disorder
- aged at 6 -15 years old
- able to understand and accept verbal instructions.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ozgun Kaya Kara, Assoc. Prof. contact
About this study
Official title: Investigating the Fine and Gross Motor Performance in Children With Attention Deficit Hyperactivity Disorder
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- attention deficit hyperactivity disorder, motor skills, Children
- 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 |
|---|---|---|
| ADHD group | Children with ADHD | |
| Control Group | Typically developing children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Proficiency
The Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) was used for the evaluation of gross and fine motor skills
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start30 Jun 2023 (estimated)
- Primary completion3 Sep 2023 (estimated)
- Study completion16 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
- Investigators
- Ozgun Kaya Kara, Assoc. Prof., Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897437
- Sponsor's protocol ID
- 2020-271
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25649325Goulardins 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.
PubMed 22940157Cho H, Ji S, Chung S, Kim M, Joung YS. Motor function in school-aged children with attention-deficit/hyperactivity disorder in Korea. Psychiatry Investig. 2014 Jul;11(3):223-7. doi: 10.4306/pi.2014.11.3.223. Epub 2014 Jul 21.
PubMed 25110492Mao HY, Kuo LC, Yang AL, Su CT. Balance in children with attention deficit hyperactivity disorder-combined type. Res Dev Disabil. 2014 Jun;35(6):1252-8. doi: 10.1016/j.ridd.2014.03.020. Epub 2014 Mar 28.
PubMed 24685941Rosa Neto F, Goulardins JB, Rigoli D, Piek JP, Oliveira JA. Motor development of children with attention deficit hyperactivity disorder. Braz J Psychiatry. 2015 Jul-Sep;37(3):228-34. doi: 10.1590/1516-4446-2014-1533.
PubMed 26376053
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Fine and Gross Motor Performance in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05897437
- Acronym / sponsor ID
- 2020-271
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- attention deficit hyperactivity disorder, motor skills, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 3 Sep 2023 (estimated)
- Study completion
- 16 Sep 2023 (estimated)
- First posted
- 9 Jun 2023 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | –Children with ADHD |
| Control Group | – | –Typically developing children |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The children with ADHD
Key inclusion criteria (3 listed)
- Clinical diagnosis of children with attention deficit hyperactivity disorder
- aged at 6 -15 years old
- able to understand and accept verbal instructions.
Key exclusion criteria (3 listed)
- 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.
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
Motor Proficiency
Time frame: One day
The Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) was used for the evaluation of gross and fine motor skills
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 25649325Polanczyk 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.
- Background: PubMed 22940157Goulardins 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.
- Background: PubMed 25110492Cho H, Ji S, Chung S, Kim M, Joung YS. Motor function in school-aged children with attention-deficit/hyperactivity disorder in Korea. Psychiatry Investig. 2014 Jul;11(3):223-7. doi: 10.4306/pi.2014.11.3.223. Epub 2014 Jul 21.
- Background: PubMed 24685941Mao HY, Kuo LC, Yang AL, Su CT. Balance in children with attention deficit hyperactivity disorder-combined type. Res Dev Disabil. 2014 Jun;35(6):1252-8. doi: 10.1016/j.ridd.2014.03.020. Epub 2014 Mar 28.
- Background: PubMed 26376053Rosa Neto F, Goulardins JB, Rigoli D, Piek JP, Oliveira JA. Motor development of children with attention deficit hyperactivity disorder. Braz J Psychiatry. 2015 Jul-Sep;37(3):228-34. doi: 10.1590/1516-4446-2014-1533.
- Individual participant dataSharing planned: No
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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.
Ozgun Kaya Kara, Assoc. Prof. contact
Ozgun Kaya Kara, Assoc. Prof. principal investigator
Akdeniz University
1 site 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 Hyperactivity Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ishak Isık, Prof. Dr. (02422494400, etik.kurul.07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Proficiency (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897437, which also lists 5 linked publications.
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 6 Jul 2023.