StrokePOPPALNCT06476262
Occupational Gaps After Mild Stroke: a Single-Center Observational Study
An observational study of Stroke and Occupational Problems, run by Grosmaire at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Occupational Problems
- What is being tested?
- This research has only one arm. The intervention focuses on occupational issue
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2023to 26 Jun 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population was selected from the active file of stroke patients undergoing post-stroke consultation at the Centre Hospitalier Sud Francilien.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
- Conditions
- Stroke, Occupational Problems
- Being tested
- This research has only one arm. The intervention focuses on occupational issue
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This research has only one arm. The intervention focuses on occupational issueBehavioural
During the post-stroke consultation, each participant is invited to complete questionnaires on occupational gaps, mood disorders, fatigue, cognition, and quality of life.
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Gaps Questionnaire
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.
Measured: the OGQ was administred at the inclusion
Secondary outcomes (5)
Hospital Anxiety and Depression scale
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
Measured: HADS was asministred at the inclusion
Montreal Cognitive Assessment
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.
Measured: MoCA was administred at the inclusion
Stroke Impact Scale
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.
Measured: The SIS was administred at the inclusion
modified Ranking Scale
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.
Measured: The mRS was administred at the inclusion
Fatigue Severity Scale
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.
Measured: The FSS was administred at the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start13 Feb 2023
- Primary completion11 May 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grosmaire
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Sud Francilien
- Responsible party
- Sponsor-investigator, Grosmaire, Clinique Les Trois Soleils
- Investigators
- Christophe T Duret, MD, Principal investigator, Clinique Les Trois Soleils
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476262
- Sponsor's protocol ID
- POPPAL
- Acronym
- POPPAL
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Occupational Gaps After Mild Stroke: Prevalence, Explanatory Factors, and Impact on Quality of Life in a Single-Center Study
- ClinicalTrials.gov ID
- NCT06476262
- Acronym / sponsor ID
- POPPAL / POPPAL
- Conditions
- Stroke, Occupational Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GrosmaireUniversity, hospital or other
- Collaborators
- Centre Hospitalier Sud Francilien
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 26 Jun 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was selected from the active file of stroke patients undergoing post-stroke consultation at the Centre Hospitalier Sud Francilien.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| This research has only one arm. The intervention focuses on occupational issueDuring the post-stroke consultation, each participant is invited to complete questionnaires on occupational gaps, mood disorders, fatigue, cognition, and quality of life. | Behavioural | – |
Primary outcome
Occupational Gaps Questionnaire
Time frame: the OGQ was administred at the inclusion
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.
5 secondary outcomes
Hospital Anxiety and Depression scale
Time frame: HADS was asministred at the inclusion
Montreal Cognitive Assessment
Time frame: MoCA was administred at the inclusion
Stroke Impact Scale
Time frame: The SIS was administred at the inclusion
modified Ranking Scale
Time frame: The mRS was administred at the inclusion
Fatigue Severity Scale
Time frame: The FSS was administred at the inclusion
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 18 Mar 2026.
- 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.
Christophe T Duret, MD principal investigator
Clinique Les Trois Soleils
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 and Occupational Problems, run by Grosmaire at 1 site in France.
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 5 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 18 Mar 2026. 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 France. 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?
Occupational Gaps Questionnaire (time frame: the OGQ was administred at the inclusion). 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 18 Mar 2026.