NCT03277027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

September 7, 2017

Last Update Submit

July 22, 2018

Conditions

Cerebral PalsyQuality of LifePhysical ActivityPhysical DisabilityParentingSleep Disorder

Keywords

cerebral palsyHealth-Related Quality Of LifePhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    vector magnitude, steps, percentage of sedentary time monitored with Actigraph

    Monitored for a week

Secondary Outcomes (3)

  • health related quality of life

    Once (cross sectional)

  • Parenting stress

    Once (cross sectional)

  • Quality of sleep

    Monitored for a week

Interventions

interventional studyOTHER

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)

Also known as: Wear a monitoring equipment (Actigraph) for a week

Eligibility Criteria

Age4 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with cerebral palsy, 4-19 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Cerebral PalsyMotor ActivitySleep Wake Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Hong

    St. Vincent's hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Non-randomized single group Accelerometer was weared for a week to check physical activity and sleep in children with cerebral palsy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 8, 2017

Study Start

May 26, 2017

Primary Completion

May 10, 2018

Study Completion

May 10, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

IPD is only available to main reserchers

Locations

KR(1)