ADHD - Attention Deficit Disorder with HyperactivityNCT06711406
The Effect of Attention on Postural Control
An observational study of ADHD - Attention Deficit Disorder with Hyperactivity and Postural Instability, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study investigates the relationship between postural control and sustained attention in individuals with probable ADHD. Motor control issues, including balance deficits, are observed in 30-50% of children with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD - Attention Deficit Disorder with Hyperactivity, Postural Instability
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 30 Dec 2024
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study was planned with healthy young volunteers (18-30-year-olds) who have the potential to have ADHD. Our target population was university students.
Who may be able to join
- Volunteers between 18-30-year-olds
- Not having any problems with balance
Who cannot join
- Having a physical injury in the last 6 months (such as ankle sprain)
- Having any neurological disorder
- Exercising regularly for the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Objective: This study investigates the relationship between postural control and sustained attention in individuals with probable ADHD. Motor control issues, including balance deficits, are observed in 30-50% of children with ADHD. These deficits may extend into adulthood, yet research on postural control in adults with ADHD is limited. This study aims to address this gap by exploring the connection between attention and postural stability in adults with ADHD.
Background: ADHD is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity, affecting both children and adults. Studies have shown that postural control relies on coordinated functioning of sensory and neuromotor systems, which ADHD may impact. In children, postural challenges are more pronounced in conditions requiring complex sensory integration. However, research on adults with ADHD is sparse, though preliminary findings suggest postural instability and possible links to cerebellar differences.
Read more
Methodology: The study evaluates sustained attention and postural control in adults with ADHD, using the Adult ADHD Screening Scale (ASRS-5) and postural stability assessments under dual-task conditions. By examining attention-driven postural responses, the study contributes to developing therapeutic balance protocols for individuals with ADHD.
Hypotheses:
H0: No relationship exists between postural control and sustained attention in individuals with ADHD.
H1: A relationship exists between postural control and sustained attention in individuals with ADHD.
Significance: This study contributes to a better understanding of the neurophysiological links
- Keywords
- ADHD, Posture, Attention, Balance, Dual task
- 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 |
|---|---|---|
| ASRS-5 score above 14 | This group consists of participants who have a score of 14 and above on the Adult ADHD Self-Report Scale (ASRS-5). Participants with these scores are more susceptible to ADHD. The group does two cognitive tests, the Sustained Attention to Response Test (SART) TEST. Furthermore, the assessment of their Postural Control is conducted using a force plate. | |
| ASRS-5 score Below 14 | This group consists of participants who have a score below 14 on the Adult ADHD Self-Report Scale (ASRS-5). Participants with these scores are less susceptible to ADHD. Participants with these scores are more vulnerable to ADHD. The group does two cognitive tests, the Sustained Attention to Response Test (SART) TEST. Furthermore, the assessment of their Postural Control is conducted using a force plate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Control: Prokin PK 252.
The Prokin device (Prokin PK 252) is a proprioceptive system for static and dynamic balance assessment and training. The device shows multiple programs for balance assessment and treatment. For this experiment, the "Static Stability Assessment Program" will be chosen to provide detailed and precise data of each participant while static standing through the stabilometry platform and the sensor placed on the trunk. Stabilometry allows participants to be evaluated by detecting the oscillation of the Centre of Pressure (CoP) during static standing. The platform of the Prokin device will calculate the CoP sways of the participants and the postural control data will be transferred to the computer screen. The assessment will be done in two conditions: a two-foot standing position without stimulus (eyes open, eyes closed), and a two-foot standing position with dual-task (eyes open, eyes closed). The dual-task procedure involves instructing participants to count down from 100 by 3.
Measured: 30 minutes
Secondary outcomes (1)
Cognitive tests: Sustained Attention to Response Task (SART):
The Sustained Attention to Response Task (SART) is a computer-based task where participants need to refrain from responding to a rare target (the digit 3) embedded within a series of more frequent non-targets (0-2, 4-9). Participants were instructed to prioritize both accuracy and speed in completing the task.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Feb 2024
- Primary completion1 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Attention Deficit Disorder with HyperactivityStudies 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Yazıcı Mutlu, Yeditepe University
- Investigators
- Çiğdem Yazıcı Mutlu, PhD, Study director, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711406
- Sponsor's protocol ID
- Effect of Attention on Posture
- Status last verified
- Jan 2025
- First submitted
- 25 Nov 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Attention on Postural Control
- ClinicalTrials.gov ID
- NCT06711406
- Acronym / sponsor ID
- Effect of Attention on Posture
- Keywords
- ADHD, Posture, Attention, Balance, Dual task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 2 Dec 2024 (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: This study investigates the relationship between postural control and sustained attention in individuals with probable ADHD. Motor control issues, including balance deficits, are observed in 30-50% of children with ADHD. These deficits may extend into adulthood, yet research on postural control in adults with ADHD is limited. This study aims to address this gap by exploring the connection between attention and postural stability in adults with ADHD.
Background: ADHD is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity, affecting both children and adults. Studies have shown that postural control relies on coordinated functioning of sensory and neuromotor systems, which ADHD may impact. In children, postural challenges are more pronounced in conditions requiring complex sensory integration. However, research on adults with ADHD is sparse, though preliminary findings suggest postural instability and possible links to cerebellar differences.
Methodology: The study evaluates sustained attention and postural control in adults with ADHD, using the Adult ADHD Screening Scale (ASRS-5) and postural stability assessments under dual-task conditions. By examining attention-driven postural responses, the study contributes to developing therapeutic balance protocols for individuals with ADHD.
Hypotheses:
H0: No relationship exists between postural control and sustained attention in individuals with ADHD.
H1: A relationship exists between postural control and sustained attention in individuals with ADHD.
Significance: This study contributes to a better understanding of the neurophysiological links
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASRS-5 score above 14 | – | –This group consists of participants who have a score of 14 and above on the Adult ADHD Self-Report Scale (ASRS-5). Participants with these scores are more susceptible to ADHD. The group does two cognitive tests, the Sustained Attention to Response Test (SART) TEST. Furthermore, the assessment of their Postural Control is conducted using a force plate. |
| ASRS-5 score Below 14 | – | –This group consists of participants who have a score below 14 on the Adult ADHD Self-Report Scale (ASRS-5). Participants with these scores are less susceptible to ADHD. Participants with these scores are more vulnerable to ADHD. The group does two cognitive tests, the Sustained Attention to Response Test (SART) TEST. Furthermore, the assessment of their Postural Control is conducted using a force plate. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study was planned with healthy young volunteers (18-30-year-olds) who have the potential to have ADHD. Our target population was university students.
Key inclusion criteria (2 listed)
- Volunteers between 18-30-year-olds
- Not having any problems with balance
Key exclusion criteria (3 listed)
- Having a physical injury in the last 6 months (such as ankle sprain)
- Having any neurological disorder
- Exercising regularly for the last 12 months
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
Postural Control: Prokin PK 252.
Time frame: 30 minutes
The Prokin device (Prokin PK 252) is a proprioceptive system for static and dynamic balance assessment and training. The device shows multiple programs for balance assessment and treatment. For this experiment, the "Static Stability Assessment Program" will be chosen to provide detailed and precise data of each participant while static standing through the stabilometry platform and the sensor placed on the trunk. Stabilometry allows participants to be evaluated by detecting the oscillation of the Centre of Pressure (CoP) during static standing. The platform of the Prokin device will calculate the CoP sways of the participants and the postural control data will be transferred to the computer screen. The assessment will be done in two conditions: a two-foot standing position without stimulus (eyes open, eyes closed), and a two-foot standing position with dual-task (eyes open, eyes closed). The dual-task procedure involves instructing participants to count down from 100 by 3.
1 secondary outcome
Cognitive tests: Sustained Attention to Response Task (SART):
Time frame: 5 minutes
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 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Çiğdem Yazıcı Mutlu, PhD study director
Yeditepe 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 ADHD - Attention Deficit Disorder with Hyperactivity and Postural Instability, run by Yeditepe 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 2 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: finished, as of the sponsor's last update on 23 Jan 2025. 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: Prokin PK 252. (time frame: 30 minutes). 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 23 Jan 2025.