Covid-19 Pandemic and Cerebral Palsy

Covid19 Clinical Trial

Official title:

Evaluation The Effect of The Covid-19 Pandemic on Children With CerebralPalsy and The Caregivers' Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686565
• Other study ID #: CP-covid
• Status: Recruiting
• Start date: February 15, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2021
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Damla Cankurtaran, MD
• Phone: +905054558101
• Email: damlacengizftr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Quality of Life
• Cerebral Palsy
• Covid19
• Developmental Disabilities
• Disability, Developmental
• Telemedicine

Locations

Country	Name	City	State
Turkey	Diskapi Education and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View 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. 2020 Aug 18. pii: S1877-0657(20)30157-3. doi: 10.1016/j.rehab.2020.08.001. [Epub ahead of print] — View 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. 2020 May 8:1-9. doi: 10.1007/s11469-020-00294-0. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 seconds
Primary	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.	10 seconds
Primary	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	30 seconds
Primary	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.	10 seconds