Back to resultsHealth Related Lifestyle and Quality of Life in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy, Quality of Life, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
interventional study
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy focused on measuring cerebral palsy, Health-Related Quality Of Life, Physical Activity
Eligibility Criteria
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.
Sites / Locations
- St. Vincent's hospital
Outcomes
Primary Outcome Measures
Physical activity
vector magnitude, steps, percentage of sedentary time monitored with Actigraph
Secondary Outcome Measures
health related quality of life
Checked with Child Health Questionnaire Parent Form 50 (CHQ-PF50) by parents
Parenting stress
Checked with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents
Quality of sleep
Sleep efficiency, number of awakening monitored with Actigraph
Full Information
NCT ID
NCT03277027
First Posted
September 7, 2017
Last Updated
July 22, 2018
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT03277027
Brief Title
Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy
Official Title
Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
May 10, 2018 (Actual)
Study Completion Date
May 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Quality of Life, Physical Activity, Physical Disability, Parenting, Sleep Disorder
Keywords
cerebral palsy, Health-Related Quality Of Life, Physical Activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-randomized single group Accelerometer was weared for a week to check physical activity and sleep in children with cerebral palsy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
interventional study
Other Intervention Name(s)
Wear a monitoring equipment (Actigraph) for a week
Intervention Description
The participants wear a monitoring equipment (Actigraph) for a week. And parents do Child Health Questionnaire Parent Form 50 (CHQ-PF50), and Korean Parenting Stress Index-Short Form (K-PSI-SF)
Primary Outcome Measure Information:
Title
Physical activity
Description
vector magnitude, steps, percentage of sedentary time monitored with Actigraph
Time Frame
Monitored for a week
Secondary Outcome Measure Information:
Title
health related quality of life
Description
Checked with Child Health Questionnaire Parent Form 50 (CHQ-PF50) by parents
Time Frame
Once (cross sectional)
Title
Parenting stress
Description
Checked with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents
Time Frame
Once (cross sectional)
Title
Quality of sleep
Description
Sleep efficiency, number of awakening monitored with Actigraph
Time Frame
Monitored for a week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong
Organizational Affiliation
St. Vincent's hospital, The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's hospital
City
Suwon-si
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD is only available to main reserchers
Learn more about this trial
Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy
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