EpilepsyNCT06529133
The Effect of Dual Task on Postural Control in Children Diagnosed with Epilepsy
A study of Epilepsy and Cognitive Function 1, Social, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
An individual's postural control is often accompanied by other tasks in daily life, such as cognitive tasks. Cognitive dual task (cognitive dual task) is the ability to perform two or more cognitive and motor activities simultaneously. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Cognitive Function 1, Social, Balance; Distorted
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2024to 15 Jan 2025
- Phase
- Interventional
- 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 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between the ages of 7-16
- Having been diagnosed with epilepsy
- Having had a seizure in the last 2 years
- Being on antiepileptic medication
- Having a body mass index within normal limits (18.5-24.9 kg/m2)
- Being between the ages of 7-16
- Having a body mass index within normal limits (18.5-24.9 kg/m2)
Who cannot join
- Being hypermobile (Beighton score >5 and above)
- Leg length inequality
- Having any neurological, rheumatic, musculoskeletal, metabolic and connective tissue disease
- Pain, deformity or surgical history related to the vertebral column and lower extremity
- Presence of cognitive, mental and/or serious psychiatric disease
- Participating in any exercise program or sporting activity in the last six months
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- Hearing and/or vision loss
- For the control group:
- Being hypermobile (Beighton score >5 and above)
- Leg length inequality
- Having any neurological, rheumatic, musculoskeletal, metabolic and connective tissue disease
- Pain, deformity or surgical history related to the vertebral column and lower extremity
- Presence of cognitive, mental and/or serious psychiatric disease
- Participating in any exercise program or sporting activity in the last six months
- Hearing and/or vision loss
Trial locations and contacts
1 site in 1 country.
About this study
An individual's postural control is often accompanied by other tasks in daily life, such as cognitive tasks. Cognitive dual task (cognitive dual task) is the ability to perform two or more cognitive and motor activities simultaneously. There are studies in the literature that address the postural control of different patient populations and healthy individuals while performing a cognitive task. To our knowledge, there is no study evaluating the postural control skills of children with epilepsy during a cognitive dual task using dynamic posturography (Biodex). In this respect, it is possible to say that our study constitutes the first study that can contribute to the literature on this subject.
Read the detailed description
Epilepsy is often characterized by seizures, but may also include additional neurological signs and symptoms that affect the prognosis of the disease. These clinical findings include hypotonia, athetosis, ataxia, inadequate visual-motor functioning, gait abnormalities, balance disorders and learning disabilities. In the literature, it has been reported that individuals with epilepsy who use antiepileptic drugs have more balance problems than those who do not. It is also reported that people with epilepsy exercise less than the general population and have a lower level of functionality compared to their peers. It has also been reported that there is a relationship between age at onset of epilepsy and motor problems.
Executive functions include cognitive processes that support complex, goal-directed behavior, especially in novel situations or situations that require conscious effort. In children diagnosed with epilepsy, visuospatial skills are frequently affected within the scope of executive function.
Postural control mechanism is a complex neural function consisting of the integrated function of sensory input, motor output and modulation by cerebellar and cognitive influences. Lack of coordination and postural instability, motor limitations in patients with epilepsy, and disabilities due to seizures are complaints due to side effects of antiepileptics. Inadequate postural control, which involves the orientation of the body for stabilization in space or task-oriented orientation in harmony with the environment, limits the individual's ability to adapt to the environment or unexpected situations.
An individual's postural control is often accompanied by other tasks in daily life, such as cognitive tasks. Cognitive dual task (cognitive dual task) is the ability to perform two or more cognitive and motor activities simultaneously. There are studies in the literature that address the postural control of different patient populations and healthy individuals while performing a cognitive task. To our knowledge, there is no study evaluating the postural control skills of children with epilepsy during a cognitive dual task using dynamic posturography (Biodex). In this respect, it is possible to say that our study constitutes the first study that can contribute to the literature on this subject.
15 children who are followed up with a diagnosis of epilepsy at Istanbul Faculty of Medicine Child Neurology Polyclinic and who meet the inclusion criteria will be included in the study as the study group, and 15 healthy children in the same age group will be included in the study as the control group. Informed consent will be obtained from each child and parent and the study will be conducted in accordance with the Declaration of Helsinki.
Evaluations and testing of all cases will be carried out in Bezmialem Vakıf University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric and Cardiac Physiotherapy and Rehabilitation Training and Research Laboratories.
After the demographic information of all children to be included in the study is recorded, they will be informed about the tests to be applied during the cognitive dual task.
Children's postural control abilities will be evaluated with the Biodex Balance System SD (BBS, Biodex Medical Systems, Shirley, NY, USA). With BBS; Postural stability, stability limits and modified sensory integration test (mCTSIB) tests will be performed. Half an hour later, the same tests will be repeated during the cognitive dual task. Cognitive tasks; counting days-months-seasons, rhythmic forward and backward counting (counting by 2s, 3s, 5s, 10s, etc.), counting words related to the specified letter (such as animal names starting with the letter A, city names). Each test will be performed 3 times for 20 seconds.
- Conditions
- Epilepsy, Cognitive Function 1, Social, Balance; Distorted, Children
- Being tested
- Evaluation of postural control
- Keywords
- Children, Cognitive dual task, Epilepsy, Postural control
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of postural controlOther
Postural stability, limits of stability, and modified clinical test of sensory interaction in balance tests will be performed with Biodex Balance System (BBS). 1) Postural Stability: The test will be performed on a stable platform and mean, anterior/posterior and medial/lateral stability indices will be calculated. 2) Limits of Stability: The test will be performed on a static platform and directional control will be evaluated and expressed as a percentage value. 3) Modified Clinical Test of Sensory Interaction in Balance: The test will be performed with a static platform setting on a flat surface with eyes open and eyes closed, on a foam floor with eyes open and eyes closed. Half an hour later, the same tests will be repeated during the cognitive dual task. The cognitive tasks given were counting day-month-season, rhythmic forward and backward counting (counting by 2, 3, 5, 10, etc.), counting words related to a given letter (animal names starting with the letter A, city names, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Healthy children Receives: Other: Evaluation of postural control |
| Study Group | Experimental | Children with diagnosed epilepsy Receives: Other: Evaluation of postural control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of postural control under two conditions
Postural control abilities of the children will be evaluated with Biodex Balance System (BBS). Half an hour later, the same tests will be repeated during the cognitive dual task.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start26 Jul 2024
- Primary completion30 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529133
- Sponsor's protocol ID
- 2024/248
- Status last verified
- Nov 2024
- First submitted
- 26 Jul 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual Task on Postural Control in Children Diagnosed with Epilepsy
- ClinicalTrials.gov ID
- NCT06529133
- Acronym / sponsor ID
- 2024/248
- Conditions
- Epilepsy, Cognitive Function 1, Social, Balance; Distorted, Children
- Keywords
- Children, Cognitive dual task, Epilepsy, Postural control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 31 Jul 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.
An individual's postural control is often accompanied by other tasks in daily life, such as cognitive tasks. Cognitive dual task (cognitive dual task) is the ability to perform two or more cognitive and motor activities simultaneously. There are studies in the literature that address the postural control of different patient populations and healthy individuals while performing a cognitive task. To our knowledge, there is no study evaluating the postural control skills of children with epilepsy during a cognitive dual task using dynamic posturography (Biodex). In this respect, it is possible to say that our study constitutes the first study that can contribute to the literature on this subject.
Detailed description
Epilepsy is often characterized by seizures, but may also include additional neurological signs and symptoms that affect the prognosis of the disease. These clinical findings include hypotonia, athetosis, ataxia, inadequate visual-motor functioning, gait abnormalities, balance disorders and learning disabilities. In the literature, it has been reported that individuals with epilepsy who use antiepileptic drugs have more balance problems than those who do not. It is also reported that people with epilepsy exercise less than the general population and have a lower level of functionality compared to their peers. It has also been reported that there is a relationship between age at onset of epilepsy and motor problems.
Executive functions include cognitive processes that support complex, goal-directed behavior, especially in novel situations or situations that require conscious effort. In children diagnosed with epilepsy, visuospatial skills are frequently affected within the scope of executive function.
Postural control mechanism is a complex neural function consisting of the integrated function of sensory input, motor output and modulation by cerebellar and cognitive influences. Lack of coordination and postural instability, motor limitations in patients with epilepsy, and disabilities due to seizures are complaints due to side effects of antiepileptics. Inadequate postural control, which involves the orientation of the body for stabilization in space or task-oriented orientation in harmony with the environment, limits the individual's ability to adapt to the environment or unexpected situations.
An individual's postural control is often accompanied by other tasks in daily life, such as cognitive tasks. Cognitive dual task (cognitive dual task) is the ability to perform two or more cognitive and motor activities simultaneously. There are studies in the literature that address the postural control of different patient populations and healthy individuals while performing a cognitive task. To our knowledge, there is no study evaluating the postural control skills of children with epilepsy during a cognitive dual task using dynamic posturography (Biodex). In this respect, it is possible to say that our study constitutes the first study that can contribute to the literature on this subject.
15 children who are followed up with a diagnosis of epilepsy at Istanbul Faculty of Medicine Child Neurology Polyclinic and who meet the inclusion criteria will be included in the study as the study group, and 15 healthy children in the same age group will be included in the study as the control group. Informed consent will be obtained from each child and parent and the study will be conducted in accordance with the Declaration of Helsinki.
Evaluations and testing of all cases will be carried out in Bezmialem Vakıf University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric and Cardiac Physiotherapy and Rehabilitation Training and Research Laboratories.
After the demographic information of all children to be included in the study is recorded, they will be informed about the tests to be applied during the cognitive dual task.
Children's postural control abilities will be evaluated with the Biodex Balance System SD (BBS, Biodex Medical Systems, Shirley, NY, USA). With BBS; Postural stability, stability limits and modified sensory integration test (mCTSIB) tests will be performed. Half an hour later, the same tests will be repeated during the cognitive dual task. Cognitive tasks; counting days-months-seasons, rhythmic forward and backward counting (counting by 2s, 3s, 5s, 10s, etc.), counting words related to the specified letter (such as animal names starting with the letter A, city names). Each test will be performed 3 times for 20 seconds.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Evaluation of postural controlHealthy children |
| Study Group | Experimental | Other: Evaluation of postural controlChildren with diagnosed epilepsy |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Being between the ages of 7-16
- Having been diagnosed with epilepsy
- Having had a seizure in the last 2 years
- Being on antiepileptic medication
- Having a body mass index within normal limits (18.5-24.9 kg/m2)
Key exclusion criteria (15 listed)
- Being hypermobile (Beighton score >5 and above)
- Leg length inequality
- Having any neurological, rheumatic, musculoskeletal, metabolic and connective tissue disease
- Pain, deformity or surgical history related to the vertebral column and lower extremity
- Presence of cognitive, mental and/or serious psychiatric disease
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 |
|---|---|---|
| Evaluation of postural controlPostural stability, limits of stability, and modified clinical test of sensory interaction in balance tests will be performed with Biodex Balance System (BBS). 1) Postural Stability: The test will be performed on a stable platform and mean, anterior/posterior and medial/lateral stability indices will be calculated. 2) Limits of Stability: The test will be performed on a static platform and directional control will be evaluated and expressed as a percentage value. 3) Modified Clinical Test of Sensory Interaction in Balance: The test will be performed with a static platform setting on a flat surface with eyes open and eyes closed, on a foam floor with eyes open and eyes closed. Half an hour later, the same tests will be repeated during the cognitive dual task. The cognitive tasks given were counting day-month-season, rhythmic forward and backward counting (counting by 2, 3, 5, 10, etc.), counting words related to a given letter (animal names starting with the letter A, city names, etc.). | Other | Control Group, Study Group |
Primary outcome
Evaluation of postural control under two conditions
Time frame: Day 1
Postural control abilities of the children will be evaluated with Biodex Balance System (BBS). Half an hour later, the same tests will be repeated during the cognitive dual task.
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 4 Feb 2025.
- 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.
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?
A study of Epilepsy and Cognitive Function 1, Social, run by Bezmialem Vakif 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 7 inclusion and 15 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 4 Feb 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?
Evaluation of postural control under two conditions (time frame: Day 1). 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 4 Feb 2025.