Cerebral PalsyNCT04686565
Covid-19 Pandemic and Cerebral Palsy
An observational study of Cerebral Palsy and Covid19, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigator aimed to analyzed the effect of Covid-19 pandemic on the physical-psychosocial and cognitive state of the children, to benefit form the health, education services and the caregiver's quality of life with telemedicine. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy, Covid19, Telemedicine
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2020to 28 Feb 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients between the ages of 3-18 who are followed up with a diagnosis of cerebral palsy in our clinic and their primary caregivers will be included
Who may be able to join
- Patients' ages between 3-18 years
- Caregiver of Patients diagnosed as Cerebral palsy
- Patients with routine follow-ups in our clinic
- Caregivers can be reach by phone
Who cannot join
- Patients' ages under 3 and over 18 years
- --Caregivers cannot be reach by phone
- Caregivers without quality of life results for the pre-pandemic period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Diskapi Education and Research Hospital
Ankara, Altındag, 06300
Damla Cankurtaran, MD, +903125962994, damlacengizftr@gmail.com
About this study
Official title: Evaluation The Effect of The Covid-19 Pandemic on Children With CerebralPalsy and The Caregivers' Quality of Life
Investigator aimed to analyzed the effect of Covid-19 pandemic on the physical-psychosocial and cognitive state of the children, to benefit form the health, education services and the caregiver's quality of life with telemedicine.
Read the detailed description
Telemedicine is an application that provides remote healthcare services. Telemedicine method has been reported to be useful in chronic conditions such as cerebral palsy (CP). Patients with CP need regular follow-up, regular physiotherapy, orthosis use, using of antispasmodic drugs, repeated botulinum toxin applications or intrathecal baclofen to reduce spasticity and increase functionality. During the Covid-19 pandemic period, these patients could not come to their controls due to reasons such as difficulty in reaching the doctor, fear of infection transmission, could not continue physiotherapy, repeated botulinum toxin applications could not be performed and necessary operations could not be performed. In this cross sectional study, investigator aimed to analyzed the effect of Covid-19 pandemic on the physical-psychosocial and cognitive state of the children, to benefit form the health, education services and the caregiver's quality of life with telemedicine.
- Conditions
- Cerebral Palsy, Covid19, Telemedicine, Caregiver Quality of Life, Disability, Developmental
- Medical subject headings
- Cerebral Palsy, COVID-19, Developmental Disabilities
What is being measured
The primary outcome is the main question the study is designed to answer.
The status of the child to benefit from health-education services
With the 14-question questionnaire prepared by the authors, the reasons such as whether there is a disruption in the control of the patients, the reason for the flow, the use of oral medications, the use of orthoses, the application of botulinum toxin, if they are applied, the development of side effects, and the obstacle to distance education will be questioned.
Measured: 10 seconds
Physical-psychosocial and cognitive state of the child
With five questions prepared by the investigators themselves, primary caregivers will be asked to evaluate their children's disease status, mobility level, spasticity, range of motion, communication and emotional state as better, the same or worse compared to the pre-pandemic period.
Measured: 10 seconds
Caregivers' quality of life
The quality of life of the primary caregivers of the patients during the Covid-19 period will be evaluated with the Short Form-12 using the phone and compared with the results recorded in their pre-pandemic files.
It is an abbreviation of 12 questions of the 8-item, 36-question short form -36 developed to evaluate the positive and negative aspects of the health status. Patients are asked to be evaluated considering the last four weeks. The total score ranges from 0 to 100 and higher scores indicate better quality of life
Measured: 30 seconds
the Covid-19 fear levels of Caregivers
Fear of Covid-19 scale is being used to evaluated the Covid-19 fear levels of Caregivers by telephone.It is a 7-question questionnaire evaluating the fear associated with covid-19, which is evaluated with a five-item Likert scale. The lowest score is 7, the highest score is 35. As the score increases, the level of fear due to Covid-19 increases. Turkish validity and reliability has been made.
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start15 Feb 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Damla Cankurtaran, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Damla Cankurtaran, MD, Principal investigator, Diskapi Yildirim Beyazit Education and Research HospitalEce uNLU aKYUZ, Assoc Prof., Study director, Diskapi Yildirim Beyazit Education and Research HospitalNihal Tezel, MD, Study chair, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686565
- Sponsor's protocol ID
- CP-covid
- Status last verified
- Feb 2021
- First submitted
- 23 Dec 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ben-Pazi H, Beni-Adani L, Lamdan R. Accelerating Telemedicine for Cerebral Palsy During the COVID-19 Pandemic and Beyond. Front Neurol. 2020 Jun 26;11:746. doi: 10.3389/fneur.2020.00746. eCollection 2020.
PubMed 32670193Cacioppo M, Bouvier S, Bailly R, Houx L, Lempereur M, Mensah-Gourmel J, Kandalaft C, Varengue R, Chatelin A, Vagnoni J, Vuillerot C, Gautheron V, Dinomais M, Dheilly E, Brochard S, Pons C; ECHO Group. Emerging health challenges for children with physical disabilities and their parents during the COVID-19 pandemic: The ECHO French survey. Ann Phys Rehabil Med. 2021 May;64(3):101429. doi: 10.1016/j.rehab.2020.08.001. Epub 2020 Aug 18.
PubMed 32818674Satici B, Gocet-Tekin E, Deniz ME, Satici SA. Adaptation of the Fear of COVID-19 Scale: Its Association with Psychological Distress and Life Satisfaction in Turkey. Int J Ment Health Addict. 2021;19(6):1980-1988. doi: 10.1007/s11469-020-00294-0. Epub 2020 May 8.
PubMed 32395095
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation The Effect of The Covid-19 Pandemic on Children With CerebralPalsy and The Caregivers' Quality of Life
- ClinicalTrials.gov ID
- NCT04686565
- Acronym / sponsor ID
- CP-covid
- Conditions
- Cerebral Palsy, Covid19, Telemedicine, Caregiver Quality of Life, Disability, Developmental
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 28 Dec 2020 (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.
Investigator aimed to analyzed the effect of Covid-19 pandemic on the physical-psychosocial and cognitive state of the children, to benefit form the health, education services and the caregiver's quality of life with telemedicine.
Detailed description
Telemedicine is an application that provides remote healthcare services. Telemedicine method has been reported to be useful in chronic conditions such as cerebral palsy (CP). Patients with CP need regular follow-up, regular physiotherapy, orthosis use, using of antispasmodic drugs, repeated botulinum toxin applications or intrathecal baclofen to reduce spasticity and increase functionality. During the Covid-19 pandemic period, these patients could not come to their controls due to reasons such as difficulty in reaching the doctor, fear of infection transmission, could not continue physiotherapy, repeated botulinum toxin applications could not be performed and necessary operations could not be performed. In this cross sectional study, investigator aimed to analyzed the effect of Covid-19 pandemic on the physical-psychosocial and cognitive state of the children, to benefit form the health, education services and the caregiver's quality of life with telemedicine.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients between the ages of 3-18 who are followed up with a diagnosis of cerebral palsy in our clinic and their primary caregivers will be included
Key inclusion criteria (4 listed)
- Patients' ages between 3-18 years
- Caregiver of Patients diagnosed as Cerebral palsy
- Patients with routine follow-ups in our clinic
- Caregivers can be reach by phone
Key exclusion criteria (3 listed)
- Patients' ages under 3 and over 18 years
- --Caregivers cannot be reach by phone
- Caregivers without quality of life results for the pre-pandemic period
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
The status of the child to benefit from health-education services
Time frame: 10 seconds
With the 14-question questionnaire prepared by the authors, the reasons such as whether there is a disruption in the control of the patients, the reason for the flow, the use of oral medications, the use of orthoses, the application of botulinum toxin, if they are applied, the development of side effects, and the obstacle to distance education will be questioned.
Physical-psychosocial and cognitive state of the child
Time frame: 10 seconds
With five questions prepared by the investigators themselves, primary caregivers will be asked to evaluate their children's disease status, mobility level, spasticity, range of motion, communication and emotional state as better, the same or worse compared to the pre-pandemic period.
Caregivers' quality of life
Time frame: 30 seconds
The quality of life of the primary caregivers of the patients during the Covid-19 period will be evaluated with the Short Form-12 using the phone and compared with the results recorded in their pre-pandemic files. It is an abbreviation of 12 questions of the 8-item, 36-question short form -36 developed to evaluate the positive and negative aspects of the health status. Patients are asked to be evaluated considering the last four weeks. The total score ranges from 0 to 100 and higher scores indicate better quality of life
the Covid-19 fear levels of Caregivers
Time frame: 10 seconds
Fear of Covid-19 scale is being used to evaluated the Covid-19 fear levels of Caregivers by telephone.It is a 7-question questionnaire evaluating the fear associated with covid-19, which is evaluated with a five-item Likert scale. The lowest score is 7, the highest score is 35. As the score increases, the level of fear due to Covid-19 increases. Turkish validity and reliability has been made.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 32670193Ben-Pazi H, Beni-Adani L, Lamdan R. Accelerating Telemedicine for Cerebral Palsy During the COVID-19 Pandemic and Beyond. Front Neurol. 2020 Jun 26;11:746. doi: 10.3389/fneur.2020.00746. eCollection 2020.
- Background: PubMed 32818674Cacioppo M, Bouvier S, Bailly R, Houx L, Lempereur M, Mensah-Gourmel J, Kandalaft C, Varengue R, Chatelin A, Vagnoni J, Vuillerot C, Gautheron V, Dinomais M, Dheilly E, Brochard S, Pons C; ECHO Group. Emerging health challenges for children with physical disabilities and their parents during the COVID-19 pandemic: The ECHO French survey. Ann Phys Rehabil Med. 2021 May;64(3):101429. doi: 10.1016/j.rehab.2020.08.001. Epub 2020 Aug 18.
- Background: PubMed 32395095Satici B, Gocet-Tekin E, Deniz ME, Satici SA. Adaptation of the Fear of COVID-19 Scale: Its Association with Psychological Distress and Life Satisfaction in Turkey. Int J Ment Health Addict. 2021;19(6):1980-1988. doi: 10.1007/s11469-020-00294-0. Epub 2020 May 8.
- Individual participant dataSharing planned: No
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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.
Damla Cankurtaran, MD principal investigator
Diskapi Yildirim Beyazit Education and Research Hospital
Ece uNLU aKYUZ, Assoc Prof. study director
Diskapi Yildirim Beyazit Education and Research Hospital
Nihal Tezel, MD study chair
Diskapi Yildirim Beyazit Education and Research Hospital
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 Diskapi Yildirim Beyazit Education and Research Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damla Cankurtaran, MD (+905054558101, damlacengizftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The status of the child to benefit from health-education services (time frame: 10 seconds). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04686565, which also lists 3 linked publications.
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 3 Feb 2021.