AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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
Show all 15Show fewer
  • 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.

Turkey (Türkiye)1 site
  • Bezmialem Vakif University

    Istanbul

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06529133
Study groupRoleWhat they receive
Control GroupExperimentalHealthy children
Receives: Other: Evaluation of postural control
Study GroupExperimentalChildren 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.

  1. 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.

  1. First posted31 Jul 2024
  2. Study start26 Jul 2024
  3. Primary completion30 Dec 2024
  4. Study completion15 Jan 2025

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in