Cerebral PalsyNCT03277027
Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy
A study testing interventional study in people with Cerebral Palsy and Quality of Life, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 4 to 19 years
- Conditions the study is for
- Cerebral Palsy, Quality of Life, Physical Activity
- What is being tested?
- interventional study
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2017to 10 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with cerebral palsy, 4-19 years old
Who cannot join
- Patients with progressive brain lesions, tumors, leukodystrophies, etc.
- Children with mitochondrial myopathy
- Some diseases that are known to progress, Rett syndrome, etc.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy, Quality of Life, Physical Activity, Physical Disability, Parenting, Sleep Disorder
- Being tested
- interventional study
- Keywords
- cerebral palsy, Health-Related Quality Of Life, Physical Activity
- Medical subject headings
- Cerebral Palsy, Motor Activity, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventional studyOther
Also called Wear a monitoring equipment (Actigraph) for a week
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
vector magnitude, steps, percentage of sedentary time monitored with Actigraph
Measured: Monitored for a week
Secondary outcomes (3)
health related quality of life
Checked with Child Health Questionnaire Parent Form 50 (CHQ-PF50) by parents
Measured: Once (cross sectional)
Parenting stress
Checked with Korean Parenting Stress Index-Short Form (K-PSI-SF) by parents
Measured: Once (cross sectional)
Quality of sleep
Sleep efficiency, number of awakening monitored with Actigraph
Measured: Monitored for a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start26 May 2017
- Primary completion10 May 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Young Hong, The Catholic University of Korea
- Investigators
- Hong, Principal investigator, St. Vincent's hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277027
- Sponsor's protocol ID
- VC17OESI0046
- Status last verified
- Jul 2018
- First submitted
- 7 Sep 2017
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is only available to main reserchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03277027
- Acronym / sponsor ID
- VC17OESI0046
- Conditions
- Cerebral Palsy, Quality of Life, Physical Activity, Physical Disability, Parenting, Sleep Disorder
- Keywords
- cerebral palsy, Health-Related Quality Of Life, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Non-randomized single group Accelerometer was weared for a week to check physical activity and sleep in children with cerebral palsy.
Who may qualify
- Ages
- 4 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children with cerebral palsy, 4-19 years old
Key exclusion criteria (3 listed)
- Patients with progressive brain lesions, tumors, leukodystrophies, etc.
- Children with mitochondrial myopathy
- Some diseases that are known to progress, Rett syndrome, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interventional studyAlso: Wear a monitoring equipment (Actigraph) for a weekThe 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) | Other | – |
Primary outcome
Physical activity
Time frame: Monitored for a week
vector magnitude, steps, percentage of sedentary time monitored with Actigraph
3 secondary outcomes
health related quality of life
Time frame: Once (cross sectional)
Parenting stress
Time frame: Once (cross sectional)
Quality of sleep
Time frame: Monitored for a week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No. IPD is only available to main reserchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong principal investigator
St. Vincent's hospital, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interventional study in people with Cerebral Palsy and Quality of Life, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Monitored for a week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.