Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke

August 17, 2022 updated by: Annick Van Gils, KU Leuven

Cognitive disorders are common early after stroke but can be overseen in patients with mild stroke who seem to be functionally recovered but are at risk to experience difficulties in advanced daily activities affecting social, vocational and family responsibilities. Acute stroke units admit a large number of patients and adequate referral to rehabilitation services is essential in terms of quality of care. A self-evaluation tool to evaluate cognitive function was developed by the occupational therapy department.

Patients with mild strokes and pre-stroke independent for instrumental daily activities fill out this self-evaluation tool, which is a paperwork task. Semi-structured interpretation is performed by physician and may result in referral to the occupational therapist for comprehensive evaluation.

In this study the validity and reliability of the self-evaluation tool will be examined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: Self evaluation tool

Study Type

Observational

Enrollment (Actual)

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

Belgium
- - Leuven, Belgium
    - UZ Leuven

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Persons with stroke admitted to the acute stroke unit are consecutive recruited.

Description

Inclusion Criteria:

diagnose of stroke
written consent
age 18 years or older
less than 1 week after stroke onset

Exclusion Criteria:

not able to write/read
not able to understand Dutch
unilateral motor deficit in upper limb (NIHSS score for upper limb +2)
referred to stroke unit with Transcient Ischemic Attack

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

Observational Models: Cohort
Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-evaluation tool Time Frame: within one week after stroke onset	cognitive screening tool	within one week after stroke onset
Oxford Cognitive Screen Time Frame: within one week after stroke onset	cognitive measure	within one week after stroke onset
Montreal Cognitive Assessement Time Frame: within one week after stroke onset	cognitive measure	within one week after stroke onset

Collaborators and Investigators

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

Sponsor

KU Leuven

Investigators

Principal Investigator: Robin Lemmens, PhD, MD, UZ/KU Leuven

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)

September 1, 2020

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

S64120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.