NCT06529133

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

February 4, 2025

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

July 26, 2024

Last Update Submit

January 31, 2025

Conditions

EpilepsyCognitive Function 1, SocialBalance; DistortedChildren

Keywords

ChildrenCognitive dual taskEpilepsyPostural control

Outcome Measures

Primary Outcomes (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.

    Day 1

Study Arms (2)

Control Group

EXPERIMENTAL

Healthy children

Other: Evaluation of postural control

Study Group

EXPERIMENTAL

Children with diagnosed epilepsy

Other: Evaluation of postural control

Interventions

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.).

Control GroupStudy Group

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • For the control group:
  • Being between the ages of 7-16
  • Having a body mass index within normal limits (18.5-24.9 kg/m2)
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 26, 2024

First Posted

July 31, 2024

Study Start

July 26, 2024

Primary Completion

December 30, 2024

Study Completion

January 15, 2025

Last Updated

February 4, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)