Stroke, AcuteNCT04624529
Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke
An observational study of Stroke, Acute and Cognitive Dysfunction, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Cognitive Dysfunction
- What is being tested?
- Self evaluation tool
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with stroke admitted to the acute stroke unit are consecutive recruited.
Who may be able to join
- diagnose of stroke
- written consent
- age 18 years or older
- less than 1 week after stroke onset
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke, Acute, Cognitive Dysfunction
- Being tested
- Self evaluation tool
- Keywords
- Occupational therapy, Evaluation tool
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self evaluation toolOther
This self-evaluation tool to evaluate cognitive function, developed by the occupational therapy department, is a paperwork task with guidelines for semi-structured interpretation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-evaluation tool
cognitive screening tool
Measured: within one week after stroke onset
Oxford Cognitive Screen
cognitive measure
Measured: within one week after stroke onset
Montreal Cognitive Assessement
cognitive measure
Measured: within one week after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Sep 2020
- Primary completion1 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annick Van Gils, KU Leuven
- Investigators
- Robin Lemmens, PhD, MD, Principal investigator, UZ/KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624529
- Sponsor's protocol ID
- S64120
- Status last verified
- Aug 2022
- First submitted
- 5 Nov 2020
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke
- ClinicalTrials.gov ID
- NCT04624529
- Acronym / sponsor ID
- S64120
- Conditions
- Stroke, Acute, Cognitive Dysfunction
- Keywords
- Occupational therapy, Evaluation tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with stroke admitted to the acute stroke unit are consecutive recruited.
Key inclusion criteria (4 listed)
- diagnose of stroke
- written consent
- age 18 years or older
- less than 1 week after stroke onset
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self evaluation toolThis self-evaluation tool to evaluate cognitive function, developed by the occupational therapy department, is a paperwork task with guidelines for semi-structured interpretation. | Other | – |
Primary outcome
Self-evaluation tool
Time frame: within one week after stroke onset
cognitive screening tool
Oxford Cognitive Screen
Time frame: within one week after stroke onset
cognitive measure
Montreal Cognitive Assessement
Time frame: within one week after stroke onset
cognitive measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Lemmens, PhD, MD principal investigator
UZ/KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Cognitive Dysfunction, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-evaluation tool (time frame: within one week after stroke onset). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.