Attention Deficit Hyperactivity DisorderNCT05522478
Effect Of Methylphenidate On Balance In Children With Attention Deficit Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Attention Deficit Hyperactivity Disorder is a neurodevelopmental disorder that may have poor motor coordination and balance control. The effect of Methylphenidate treatment on balance and fall risk is still unclear. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Fall risk
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2016to Jan 2017
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All children who were diagnosed with ADHD for the first time according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V, American Psychiatric Association, 2013) were classified in the ADHD group (n=33), children with ADHD who were treated with MPH for a minimum of 3 months and were followed-up at our clinic were classified in the treatment group (n=32), and typically developing children were classified in the third-the control group (n=20) in this observational cross-sectional study.
Who may be able to join
- Children who were diagnosed with ADHD for the first time according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V, American Psychiatric Association, 2013)
Who cannot join
- neurological disorders
- psychiatric disorders
- musculoskeletal disorders
- cardiopulmonary diseases
- visual impairments
- developmental coordination disorders that could affect balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Methylphenidate On Static Balance And Fall Risk In Children With Attention Deficit Hyperactivity Disorder: Cross-Sectional Study
Attention Deficit Hyperactivity Disorder is a neurodevelopmental disorder that may have poor motor coordination and balance control. The effect of Methylphenidate treatment on balance and fall risk is still unclear. This study aimed to evaluate the effect of methylphenidate (MPH) treatment on balance, fall risk, and sensorimotor integration in children with Attention Deficit Hyperactivity Disorder (ADHD).
Read the detailed description
Children who were diagnosed with ADHD for the first time were classified in the ADHD group (n=33), children with ADHD who were treated with MPH for a minimum of 3 months were classified in the treatment group (n=32), and typically developing children were classified in the third-the control group (n=20) in this observational cross-sectional study. Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.Postural stability tests, including overall stability index (OSI), anterior-posterior stability index (APSI), and medial-lateral stability index (MLSI), were used to evaluate postural control. The Modified Clinical Test of Sensory Interaction in Balance (m-CTSIB) testing protocol was used to evaluate sensory integration capabilities and balance. Fall risk was evaluated by biodex balance system.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Fall risk
- Keywords
- Attention Deficit Hyperactivity Disorder, Methylphenidate, Postural Balance
- 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.
Fall riskDevice
Also called static postural balance, sensorimotor integration (m-CTSIB) test
Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Children who were diagnosed with ADHD for the first time were classified in the ADHD group (n=33) Receives: Device: Fall risk | |
| treatment group | children with ADHD who were treated with MPH for a minimum of 3 months were classified in the treatment group (n=32) Receives: Device: Fall risk | |
| control group | typically developing children were classified in the third-the control group (n=20) Receives: Device: Fall risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural control
Postural stability tests, including overall stability index (OSI), anterior-posterior stability index (APSI), and medial-lateral stability index (MLSI)
Measured: one year
sensorimotor integration
The Modified Clinical Test of Sensory Interaction in Balance (m-CTSIB) testing protocol was used to evaluate sensory integration capabilities and balance. Four different conditions were evaluated for the m-CTSIB test protocol: Eyes Open Firm Surface (EOFS), Eyes Closed Firm Surface (ECFS), Eyes Open Soft Surface (EOSS), and Eyes Closed Soft Surface (ECSS)
Measured: one year
Fall risk
Fall risk score was calculated by Biodex balance system
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study startJul 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522478
- Sponsor's protocol ID
- Gulcan Ozturk
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 5 Jan 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Methylphenidate On Static Balance And Fall Risk In Children With Attention Deficit Hyperactivity Disorder: Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05522478
- Acronym / sponsor ID
- Gulcan Ozturk
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Methylphenidate, Postural Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Aug 2022 (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 is a neurodevelopmental disorder that may have poor motor coordination and balance control. The effect of Methylphenidate treatment on balance and fall risk is still unclear. This study aimed to evaluate the effect of methylphenidate (MPH) treatment on balance, fall risk, and sensorimotor integration in children with Attention Deficit Hyperactivity Disorder (ADHD).
Detailed description
Children who were diagnosed with ADHD for the first time were classified in the ADHD group (n=33), children with ADHD who were treated with MPH for a minimum of 3 months were classified in the treatment group (n=32), and typically developing children were classified in the third-the control group (n=20) in this observational cross-sectional study. Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.Postural stability tests, including overall stability index (OSI), anterior-posterior stability index (APSI), and medial-lateral stability index (MLSI), were used to evaluate postural control. The Modified Clinical Test of Sensory Interaction in Balance (m-CTSIB) testing protocol was used to evaluate sensory integration capabilities and balance. Fall risk was evaluated by biodex balance system.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | Device: Fall riskChildren who were diagnosed with ADHD for the first time were classified in the ADHD group (n=33) |
| treatment group | – | Device: Fall riskchildren with ADHD who were treated with MPH for a minimum of 3 months were classified in the treatment group (n=32) |
| control group | – | Device: Fall risktypically developing children were classified in the third-the control group (n=20) |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All children who were diagnosed with ADHD for the first time according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V, American Psychiatric Association, 2013) were classified in the ADHD group (n=33), children with ADHD who were treated with MPH for a minimum of 3 months and were followed-up at our clinic were classified in the treatment group (n=32), and typically developing children were classified in the third-the control group (n=20) in this observational cross-sectional study.
Key inclusion criteria (1 listed)
- Children who were diagnosed with ADHD for the first time according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V, American Psychiatric Association, 2013)
Key exclusion criteria (6 listed)
- neurological disorders
- psychiatric disorders
- musculoskeletal disorders
- cardiopulmonary diseases
- visual impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fall riskAlso: static postural balance, sensorimotor integration (m-CTSIB) testFall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System. | Device | ADHD group, control group, treatment group |
Primary outcome
postural control
Time frame: one year
Postural stability tests, including overall stability index (OSI), anterior-posterior stability index (APSI), and medial-lateral stability index (MLSI)
sensorimotor integration
Time frame: one year
The Modified Clinical Test of Sensory Interaction in Balance (m-CTSIB) testing protocol was used to evaluate sensory integration capabilities and balance. Four different conditions were evaluated for the m-CTSIB test protocol: Eyes Open Firm Surface (EOFS), Eyes Closed Firm Surface (ECFS), Eyes Open Soft Surface (EOSS), and Eyes Closed Soft Surface (ECSS)
Fall risk
Time frame: one year
Fall risk score was calculated by Biodex balance system
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 5 Jan 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.
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 Fatih Sultan Mehmet Training and Research Hospital 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jan 2024. 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?
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?
postural control (time frame: one year). The study lists 3 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 5 Jan 2024.