Covid-19 Pandemic and Cerebral Palsy

February 1, 2021 updated by: Damla Cankurtaran, Diskapi Yildirim Beyazit Education and Research Hospital

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altındag
      • Ankara, Altındag, Turkey, 06300
        • Recruiting
        • Diskapi Education and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 seconds
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.
10 seconds
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
30 seconds
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.
10 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2020

Primary Completion (Anticipated)

February 28, 2021

Study Completion (Anticipated)

February 28, 2021

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-covid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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