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

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04624529
• Other study ID #: S64120
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 30, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Stroke
• Stroke, Acute

Intervention

Other:
• Self evaluation tool
This self-evaluation tool to evaluate cognitive function, developed by the occupational therapy department, is a paperwork task with guidelines for semi-structured interpretation.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-evaluation tool	cognitive screening tool	within one week after stroke onset
Primary	Oxford Cognitive Screen	cognitive measure	within one week after stroke onset
Primary	Montreal Cognitive Assessement	cognitive measure	within one week after stroke onset