CP: Rehabilitation Status of Children With Cerebral Palsy and Anxiety of Their Caregivers During the Covid19 Pandemic

Sponsor
Fatih Sultan Mehmet Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04916873
Collaborator
(none)
206
Enrollment
1
Location
2.1
Actual Duration (Months)
99.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rehabilitation status of children with cerebral palsy (CP) and anxiety of their caregivers during the covid19 pandemic were explored. 206 caregivers who voluntarily accepted to participate were administered the State-Trait Anxiety Inventory and evaluated about the rehabilitation status of their children.The anxiety levels of all caregivers were found high and the rehabilitation programmes of the children were interrupted.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Investigators aimed to explore the rehabilitation status of children with CP and anxiety of their caregivers during the covid19 pandemic. Caregivers of children with CP who were under follow up in the outpatient CP clinic were called up during pandemic period. 206 caregivers who voluntarily accepted to participate were administered the State-Trait Anxiety Inventory and evaluated about the rehabilitation status of their children. Demographic data, associated problems of children, Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) levels were recorded from their files. For the statistical analysis, IBM SPSS Statistics 22 (SPSS IBM, Turkey) programs were used. While evaluating the study data, the suitability of the parameters to the normal distribution was evaluated with the Shapiro Wilks test. Significance was evaluated at the p <0.05 level.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    206 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Rehabilitation Status of Children With Cerebral Palsy and Anxiety of Their Caregivers During the Covid19 Pandemic
    Actual Study Start Date :
    May 28, 2020
    Actual Primary Completion Date :
    Jun 26, 2020
    Actual Study Completion Date :
    Jul 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety of the caregivers of the children with cerebral palsy [1 month]

      State-Trait Anxiety levels of caregivers of the children with cerebral palsy during the covid19 pandemic.The total score of the State-Trait Anxiety scale varies between 20 and 80. Those who score below 36 are classified as "no anxiety", those between 37-42 points as "mild anxiety" and those with 42 points and above as "high anxiety".

    2. Rehabilitation process of the children with cerebral palsy [1 month]

      Rehabilitation status of the children with cerebral palsy during the covid19 pandemic. Rehabilitation frequency of children and home exercise status are evaluated

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Caregivers of children with CP who were under follow up in the outpatient CP clinic who voluntarily accepted to participate
    Exclusion Criteria:
    • Caregivers of children with CP who were under follow up in the outpatient CP clinic who didn't accept to participate

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Pinar AkpinarIstanbulAtasehirTurkey34750

    Sponsors and Collaborators

    • Fatih Sultan Mehmet Training and Research Hospital

    Investigators

    • Principal Investigator: PINAR AKPINAR, MD, Assoc Prof

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pınar Akpınar, Assoc Prof, Fatih Sultan Mehmet Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04916873
    Other Study ID Numbers:
    • FSMEAH-KAEK 2020/56
    First Posted:
    Jun 8, 2021
    Last Update Posted:
    Jun 8, 2021
    Last Verified:
    Jun 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
    Keywords provided by Pınar Akpınar, Assoc Prof, Fatih Sultan Mehmet Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2021