NCT03814174

Brief Summary

To investigate physical fitness and activity levels in children with epilepsy and compare the results with healthy peers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

January 18, 2019

Last Update Submit

March 12, 2019

Conditions

Keywords

Childhood EpilepsyPhysical FitnessPhysical ActivityUse of Pedometer

Outcome Measures

Primary Outcomes (6)

  • Number of steps on pedometer

    Participants will wear a pedometer (physical activity monitor) for seven consecutive days.

    seven days

  • Exercise performance using 6-minute walk test

    6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded.

    1st day (before using device)

  • Health-Related Physical Fitness Test for body compozition

    body mass index

    1st day (before using device)

  • Health-Related Physical Fitness Test for strenght

    Cadance Based Curl-up Test

    1st day (before using device)

  • Health-Related Physical Fitness Test for balance

    Flamingo Balance Test

    1st day (before using device)

  • Health-Related Physical Fitness Test for flexibility

    Sit and Reach Test

    1st day (before using device)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study population will consist of children with epilepsy and their healthy peers.

You may qualify if:

  • children who were diagnosed with epilepsy
  • children who can independently continue formal education,
  • children who do not need special education
  • children who have no additional neurological and neuromuscular disease (epilepsy only)
  • children who have a normal or higher cognitive level according to the WISC-R intelligence test
  • children who were volunteers to participate in the study
  • children whose parents volunteers to participate in the study

You may not qualify if:

  • The disappearance of volunteerism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EpilepsyMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 23, 2019

Study Start

October 24, 2017

Primary Completion

May 20, 2018

Study Completion

May 30, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations