- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06476262
Occupational Gaps After Mild Stroke: a Single-Center Observational Study (POPPAL)
Investigating Occupational Gaps After Mild Stroke: Prevalence, Explanatory Factors, and Impact on Quality of Life in a Single-Center Study
The goal of this observational study is to investigate participation restrictions and their determinants in people after a mild stroke. The main questions it aims to answer are:
Do mRS score, time since stroke onset, cognitive disorders, mood disorders and fatigue negatively impact occupations after mild stroke?
Does an increased prevalence of occupational gaps correlate with a diminished quality of life following mild stroke?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Boissise-le-Roi, France, 77310
- Clinique Les Trois Soleils
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- over 18 years old,
- a diagnosis of stroke confirmed by cerebral imaging,
- an mRS score <3 at the post-stroke consultation,
- informed about the study
- not opposed to participation
Exclusion Criteria:
- cognitive dysfunction making participation in the study impossible,
- phasic disorders preventing comprehension of the questionnaires,
- neurological deficits prior to the stroke, a history of psychiatric disorders
- being under legal protection.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Occupational Gaps Questionnaire
Time Frame: the OGQ was administred at the inclusion
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The Occupational Gaps Questionnaire (OGQ) assesses presence of occupational gaps in 28 activities, i.e. instrumental ADL, social- leisure- and work/work related activities.
Two studies are published on occupational gaps.
An occupational gap is defined as the gap that occurs between what an individual wants and needs to do and what he/she actually does.
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the OGQ was administred at the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Anxiety and Depression scale
Time Frame: HADS was asministred at the inclusion
|
The Hospital Anxiety and Depression Scale (HADS) is a questionnaire widely used for detecting anxiety and depressive disorders.HADS comprises 14 items, seven of which relate to anxiety symptoms and seven to depressive symptoms.
Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, depending on the presence and severity of the symptoms
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HADS was asministred at the inclusion
|
|
Montreal Cognitive Assessment
Time Frame: MoCA was administred at the inclusion
|
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for the detection of mild cognitive impairment.
The MoCA assesses the following cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
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MoCA was administred at the inclusion
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Stroke Impact Scale
Time Frame: The SIS was administred at the inclusion
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The Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure.
It was designed to assess multidimensional stroke outcomes, including strength, hand function Activities of Daily Living / Instrumental Activities of Daily Living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation.
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The SIS was administred at the inclusion
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modified Ranking Scale
Time Frame: The mRS was administred at the inclusion
|
The Modified Rankin Scale (MRS) is a single item, global outcomes rating scale for patients post-stroke.
It is used to categorize level of functional independence with reference to pre-stroke activities rather than on observed performance of a specific task.
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The mRS was administred at the inclusion
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Fatigue Severity Scale
Time Frame: The FSS was administred at the inclusion
|
The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.
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The FSS was administred at the inclusion
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christophe T Duret, MD, Clinique Les Trois Soleils
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POPPAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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