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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03814174
Other study ID # 17/751
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 24, 2017
Est. completion date May 30, 2018

Study information

Verified date March 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Description:

Many individuals with epilepsy are physically inactive due to the fear of seizures triggered by physical activity/ exercise, and the advices given by the family members and the health care professionals to avoid intense activity . In two studies performed about this subject, this is the probable reason why adult patients with epilepsy have a weaker physical fitness than healthy individuals in the control group. However; in a study of Drawskowski et al., the avoidance of activity and exercise in individuals with epilepsy was investigated, and it was reported that the injuries and seizure problems were rare even during very intense physical activity.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 30, 2018
Est. primary completion date May 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- The disappearance of volunteerism

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of steps on pedometer Participants will wear a pedometer (physical activity monitor) for seven consecutive days. seven days
Primary 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)
Primary Health-Related Physical Fitness Test for body compozition body mass index 1st day (before using device)
Primary Health-Related Physical Fitness Test for strenght Cadance Based Curl-up Test 1st day (before using device)
Primary Health-Related Physical Fitness Test for balance Flamingo Balance Test 1st day (before using device)
Primary Health-Related Physical Fitness Test for flexibility Sit and Reach Test 1st day (before using device)
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