Cerebral PalsyNCT04970927
The Effect of Pandemic on Children With Cerebral Palsy
An observational study of Cerebral Palsy and Covid19, run by Sevda Adar at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP), is the most common cause of physical disability that begins in childhood and lasts throughout life, affecting 1 in 500 newborns, with an estimated prevalence of 17 million worldwide. Social isolation, economic conditions, interruption of treatments, etc. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cerebral Palsy, Covid19
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 10 Aug 2021
- Phase
- Observational
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: -Parents of children under the age of 18 with cerebral palsy who applied to our hospital between 01.01.2014-31.01.2021
Who may be able to join
- Parents of children under the age of 18 with cerebral palsy who applied to our hospital between 01.01.2014-31.01.2021
Who cannot join
- Parents of Cerebral Palsy Patients over 18 years of age
- Parents who cannot be reached by phone
- Parents who do not agree to fill out the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Covid-19 Pandemic on Children With Cerebral Palsy
Cerebral Palsy (CP), is the most common cause of physical disability that begins in childhood and lasts throughout life, affecting 1 in 500 newborns, with an estimated prevalence of 17 million worldwide.
Social isolation, economic conditions, interruption of treatments, etc. may cause physical, mental, behavioral and psychosocial changes in children with cerebral palsy. Discontinuing regular physiotherapy can worsen functional skills and cause complications in children with cerebral palsy. Our aim in this study is to investigate the sustainability of the treatments of children with cerebral palsy during the pandemic period, their physical and psychosocial effects, and the relationship between their parents' fear of covid-19.
- Conditions
- Cerebral Palsy, Covid19
- Keywords
- Cerebral Palsy, Covid19, Pandemics
- Medical subject headings
- Cerebral Palsy, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation Survey
A questionnaire form consisting of 19 questions and 3 parts prepared by the authors in the light of the information obtained during the clinical observation process of children with cerebral palsy will be used.
Measured: First day
Secondary outcomes (1)
Covid-19 Fear Scale
Parents' fear of COVID-19 will be evaluated with the COVID-19 fear scale consisting of 7 questions. The items of the scale were created on the basis of a comprehensive review of existing scales on fear, expert evaluations, and participant interviews.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start15 Apr 2021
- Primary completion30 Jul 2021
- Study completion10 Aug 2021
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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevda Adar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevda Adar, Afyonkarahisar Health Sciences University
- Investigators
- SEVDA ADAR, Principal investigator, Afyonkarahisar Health Sciences UniversityPETEK ŞARLAK KONYA, Study chair, Afyonkarahisar Health Sciences UniversityALİ İZZET AKÇİN, Study chair, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970927
- Sponsor's protocol ID
- SASP21
- Status last verified
- Oct 2022
- First submitted
- 12 Jul 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Covid-19 Pandemic on Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04970927
- Acronym / sponsor ID
- SASP21
- Conditions
- Cerebral Palsy, Covid19
- Keywords
- Cerebral Palsy, Covid19, Pandemics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Sevda AdarUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 21 Jul 2021 (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.
Cerebral Palsy (CP), is the most common cause of physical disability that begins in childhood and lasts throughout life, affecting 1 in 500 newborns, with an estimated prevalence of 17 million worldwide.
Social isolation, economic conditions, interruption of treatments, etc. may cause physical, mental, behavioral and psychosocial changes in children with cerebral palsy. Discontinuing regular physiotherapy can worsen functional skills and cause complications in children with cerebral palsy. Our aim in this study is to investigate the sustainability of the treatments of children with cerebral palsy during the pandemic period, their physical and psychosocial effects, and the relationship between their parents' fear of covid-19.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- -Parents of children under the age of 18 with cerebral palsy who applied to our hospital between 01.01.2014-31.01.2021
Key inclusion criteria (1 listed)
- Parents of children under the age of 18 with cerebral palsy who applied to our hospital between 01.01.2014-31.01.2021
Key exclusion criteria (3 listed)
- Parents of Cerebral Palsy Patients over 18 years of age
- Parents who cannot be reached by phone
- Parents who do not agree to fill out the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation Survey
Time frame: First day
A questionnaire form consisting of 19 questions and 3 parts prepared by the authors in the light of the information obtained during the clinical observation process of children with cerebral palsy will be used.
1 secondary outcome
Covid-19 Fear Scale
Time frame: First day
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 21 Oct 2022.
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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.
SEVDA ADAR principal investigator
Afyonkarahisar Health Sciences University
PETEK ŞARLAK KONYA study chair
Afyonkarahisar Health Sciences University
ALİ İZZET AKÇİN study chair
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Covid19, run by Sevda Adar at 1 site in Turkey (Türkiye).
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 21 Oct 2022. 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 Turkey (Türkiye). 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?
Evaluation Survey (time frame: First day). 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 21 Oct 2022.