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NCT03277027 Clinical Trial

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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03277027
Other study ID # VC17OESI0046
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2017
Est. completion date May 10, 2018

Study information
Verified date July 2018
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date May 10, 2018
Est. primary completion date May 10, 2018
Accepts healthy volunteers No
Gender All
Age group 4 Years to 19 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• interventional study
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)

Locations
Country Name City State
Korea, Republic of St. Vincent's hospital Suwon-si

Sponsors (1)
Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physical activity vector magnitude, steps, percentage of sedentary time monitored with Actigraph Monitored for a week
Secondary health related quality of life Checked with Child Health Questionnaire Parent Form 50 (CHQ-PF50) by parents Once (cross sectional)
Secondary Parenting stress Checked with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents Once (cross sectional)
Secondary Quality of sleep Sleep efficiency, number of awakening monitored with Actigraph Monitored for a week
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