- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277027
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.
- Physical activity and quality of sleep are monitored by wearing Actigraph for a week.
- Health related quality of life is checked by parents withChild Health Questionnaire Parent Form 50 (CHQ-PF50).
- 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
-
-
-
Suwon-si, Korea, Republic of
- St. Vincent's Hospital
-
-
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
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
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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