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

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 Disease	Intervention/Treatment	Phase
Cerebral Palsy Covid19 Anxiety

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

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".
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

	Site	City	State	Country	Postal Code
1	Pinar Akpinar	Istanbul	Atasehir	Turkey	34750

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:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

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