Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy

July 22, 2018 updated by: Bo Young Hong, The Catholic University of Korea
The primary aim of this study is assessing physical activity, the quality of sleep and health related quality of life in children with cerebral palsy, and parenting stress of caregivers of the children with cerebral palsy in Korea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Monitor the physical activity, health related quality of life, parenting stress according to GMFCS level in children with cerebral palsy in Korea.

  1. Physical activity and quality of sleep are monitored by wearing Actigraph for a week.
  2. Health related quality of life is checked by parents withChild Health Questionnaire Parent Form 50 (CHQ-PF50).
  3. Parenting stress is monitored with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with cerebral palsy, 4-19 years old

Exclusion Criteria:

  • Patients with progressive brain lesions, tumors, leukodystrophies, etc.
  • Children with mitochondrial myopathy
  • Some diseases that are known to progress, Rett syndrome, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: Monitored for a week
vector magnitude, steps, percentage of sedentary time monitored with Actigraph
Monitored for a week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health related quality of life
Time Frame: Once (cross sectional)
Checked with Child Health Questionnaire Parent Form 50 (CHQ-PF50) by parents
Once (cross sectional)
Parenting stress
Time Frame: Once (cross sectional)
Checked with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents
Once (cross sectional)
Quality of sleep
Time Frame: Monitored for a week
Sleep efficiency, number of awakening monitored with Actigraph
Monitored for a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Hong, St. Vincent's Hospital, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2017

Primary Completion (Actual)

May 10, 2018

Study Completion (Actual)

May 10, 2018

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 22, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC17OESI0046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD is only available to main reserchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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