Covid-19 Pandemic and Cerebral Palsy

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04686565
Collaborator
(none)
100
1
12.5
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation The Effect of The Covid-19 Pandemic on Children With CerebralPalsy and The Caregivers' Quality of Life
    Actual Study Start Date :
    Feb 15, 2020
    Anticipated Primary Completion Date :
    Feb 28, 2021
    Anticipated Study Completion Date :
    Feb 28, 2021

    Outcome Measures

    Primary Outcome Measures

    1. The status of the child to benefit from health-education services [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.

    2. Physical-psychosocial and cognitive state of the child [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.

    3. Caregivers' quality of life [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

    4. the Covid-19 fear levels of Caregivers [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diskapi Education and Research Hospital Ankara Altındag Turkey 06300

    Sponsors and Collaborators

    • Diskapi Yildirim Beyazit Education and Research Hospital

    Investigators

    • Principal Investigator: Damla Cankurtaran, MD, Diskapi Yildirim Beyazit Education and Research Hospital
    • Study Director: Ece uNLU aKYUZ, Assoc Prof., Diskapi Yildirim Beyazit Education and Research Hospital
    • Study Chair: Nihal Tezel, MD, Diskapi Yildirim Beyazit Education and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Damla Cankurtaran, Medical doctor, Diskapi Yildirim Beyazit Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04686565
    Other Study ID Numbers:
    • CP-covid
    First Posted:
    Dec 28, 2020
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2021