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

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: Quality of Life; Cerebral Palsy; Physical Activity; Sleep Disorder; Parenting; Physical Disability
• Intervention / Treatment: Other: interventional study

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

Study Locations

• Korea, Republic of
  • Suwon-si, Korea, Republic of
    • St. Vincent's Hospital

Participation Criteria

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

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

Collaborators and Investigators

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

Study record dates

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: Physical Activity; cerebral palsy; Health-Related Quality Of Life
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Sleep Wake Disorders; Paralysis
• 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