NCT04916873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

29 days

First QC Date

June 3, 2021

Last Update Submit

June 4, 2021

Conditions

Keywords

AnxietyCerebral PalsyCovid19Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Anxiety of the caregivers of the children with cerebral palsy

    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".

    1 month

  • Rehabilitation process of the children with cerebral palsy

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

    1 month

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Caregivers of children with CP who were under follow up in the outpatient CP clinic.

You may qualify if:

  • Caregivers of children with CP who were under follow up in the outpatient CP clinic who voluntarily accepted to participate

You may not qualify if:

  • Caregivers of children with CP who were under follow up in the outpatient CP clinic who didn't accept to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinar Akpinar

Istanbul, Atasehir, 34750, Turkey (Türkiye)

Location

Related Publications (2)

  • 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. 2021 May;64(3):101429. doi: 10.1016/j.rehab.2020.08.001. Epub 2020 Aug 18.

  • Dhiman S, Sahu PK, Reed WR, Ganesh GS, Goyal RK, Jain S. Impact of COVID-19 outbreak on mental health and perceived strain among caregivers tending children with special needs. Res Dev Disabil. 2020 Dec;107:103790. doi: 10.1016/j.ridd.2020.103790. Epub 2020 Oct 6.

MeSH Terms

Conditions

Cerebral PalsyCOVID-19Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMental Disorders

Study Officials

  • PINAR AKPINAR, MD

    Assoc Prof

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 8, 2021

Study Start

May 28, 2020

Primary Completion

June 26, 2020

Study Completion

July 30, 2020

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations