Clinical trial NCT04686565: Covid-19 Pandemic and Cerebral Palsy
Official title: Evaluation The Effect of The Covid-19 Pandemic on Children With CerebralPalsy and The Caregivers' Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Covid19
Telemedicine
Caregiver Quality of Life
Disability, Developmental
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The status of the child to benefit from health-education services
timeFrame: 10 seconds
measure: Physical-psychosocial and cognitive state of the child
timeFrame: 10 seconds
measure: Caregivers' quality of life
timeFrame: 30 seconds
measure: the Covid-19 fear levels of Caregivers
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Education and Research Hospital
state: Altındag
Study officials:
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Damla Cankurtaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Ece uNLU aKYUZ, Assoc Prof.
role: STUDY_DIRECTOR
affiliation: Diskapi Yildirim Beyazit Education and Research Hospital
name: Nihal Tezel, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Cacioppo 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.
citation: Satici 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.