StrokeRTWS2NCT07264387
Predictive Factors for Return to Work After a First Stroke Treated at Clermont-Ferrand University Hospital in Puy de Dôme Between January 2020 and December 2024
An observational study of Stroke, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
Stroke is a leading cause of acquired motor disability and the second most common cause of major cognitive impairment worldwide. In France, approximately 150,000 new cases occur annually, with around 31% affecting individuals of working age, making return to work (RTW) a critical public health issue. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stroke
- How many people
- 190 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Oct 2025to 22 Jan 2026
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Stroke management follows a continuum, starting with acute care in neurology and neurosurgery, then progressing to medium- and long-term multidisciplinary rehabilitation in the Physical Medicine and Rehabilitation (PMR) department of Clermont-Ferrand University Hospital. Within this context, return to work is a key objective, supported by the expertise of PMR teams and close collaboration with neurology and neurosurgery. To conduct this study, authorisation to access medical records was granted by the Medical Information Department (DIM), covering patients under 64 years old admitted for ischaemic or haemorrhagic stroke between January 2020 and December 2024. Screening will be performed on hospitalisations in neurology and neurosurgery, and all eligible patients experiencing a first stroke during this period will be invited to participate.
Who may be able to join
- Patients who have suffered an ischaemic stroke according to ICD-10 (ICD-10 code: I63 (cerebral infarction) I64 (unspecified stroke), I69 (sequelae of cerebrovascular disease) or patients who have had a haemorrhagic stroke according to ICD-10 (ICD-10 code: I60, I61 and I62) between January 2020 and December 2024
- Patients of working age/under 64 years of age (legal retirement age)
- Patients with an employment contract at the time of the stroke
- Patients treated at Clermont-Ferrand University Hospital
- Post-stroke consultation recorded in the patient's medical file
- Patients affiliated with the social security system
- Patients who have not objected to participating in the study
Who cannot join
- Patients with a history of ischaemic or haemorrhagic stroke
- Patients with a history of head trauma with neurological sequelae corresponding to codes S060, S061, S062, S063, S065, S066, S067, S068 and S069
- Patients who died as a result of stroke
- Patients unable to respond to telephone questionnaires
- Patients under guardianship or trusteeship
- Patients who have suffered a transient ischaemic attack (TIA) (G459 according to ICD 10)
Show all 11Show fewer
- Patients who were in early retirement at the time of assessment
- No information on employment after stroke in the medical file
- Patients with category 2 or 3 disability prior to stroke due to another condition
- Patients on sick leave prior to stroke due to another condition
- Patients receiving RSA income support
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clermont Ferrand University Hospital, Louise Michel site
Cébazat, France, 63118
CHU Clermont-Ferrand, Louise Michel
Clermont-Ferrand
About this study
Stroke is a leading cause of acquired motor disability and the second most common cause of major cognitive impairment worldwide. In France, approximately 150,000 new cases occur annually, with around 31% affecting individuals of working age, making return to work (RTW) a critical public health issue. Beyond the medical burden, stroke has profound socio-economic consequences, including loss of productivity, prolonged sick leave, part-time resumption, and the need for workplace adaptations. While RTW after stroke has been investigated, major gaps remain. No standardized recommendations exist for vocational reintegration, and predictive factors are still debated. Quantitative determinants such as stroke type, severity, functional independence, and occupational characteristics have been identified, but qualitative aspects-including self-efficacy, perceived social burden, employer relationships, and motivation-are poorly documented. Moreover, cognitive deficits are often insufficiently characterized, as screening tools such as MMSE or MoCA lack the sensitivity of comprehensive neuropsychological assessments. The impact of revascularization procedures on RTW and the ability to sustain employment after initial resumption also remain unclear. Importantly, no recent data are available in the Auvergne region, despite evolving labor policies that may influence reintegration trajectories. This observational study therefore aims to identify both quantitative and qualitative predictors of RTW after ischemic or hemorrhagic stroke, describe vocational pathways in a regional cohort, and explore barriers and facilitators to long-term reintegration. Ultimately, the study seeks to provide updated evidence to guide tailored rehabilitation and socio-professional reintegration strategies, supporting sustainable RTW in working-age stroke survivors.
- Conditions
- Stroke
- Keywords
- stroke, return to work, predictive factors
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work rate
Percentage of return to work after a first ischaemic or haemorrhagic stroke between January 2020 and December 2024 in patients of working age.
Measured: At inclusion
Factors correlated with return to work
Determine the factors associated with return to work (gender)
Measured: At inclusion
Factors correlated with return to work
Determine the factors associated with return to work (stroke severity)
Measured: At inclusion
Factors correlated with return to work
Determine the factors associated with return to work (stroke type (ischaemic or haemorrhagic)).
Measured: At inclusion
Factors correlated with return to work
Determine the factors associated with return to work (independence)
Measured: At inclusion
Factors correlated with return to work
Determine the factors associated with return to work (occupation)
Measured: At inclusion
Secondary outcomes (5)
Quality of life after stroke
The Short-Form-12 (SF-12) questionnaire is a standardized self-administered questionnaire used to assess health-related quality of life. It comprises 12 questions covering 8 domains: physical activities, physical and mental limitations, pain, perceived general health, vitality, mental health and social relationships. Each item is rated on a 5- or 6-point Likert scale. The responses are used to calculate two scores: a physical composite score (PCS) and a mental composite score (MCS), each ranging from 0 (perceived health status very poor) to 100 (perceived health status optimal).
Measured: At inclusion
Anxiety and Depression scale
The Hospital Anxiety and Depression Scale (HADs) questionnaire is a psychometric self-assessment questionnaire consisting of 14 items divided into two subscales (anxiety and depression) of seven items each. Each item is rated on a scale of 0 to 3. A score is given for each subscale, A for anxiety and D for depression. The score can range from 0 (no anxiety and/or depressive disorders) to 21 (proven anxiety and/or depressive disorders of varying severity) for each subscale.
Measured: At inclusion
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) questionnaire is a self-assessment tool used to evaluate the severity of fatigue and its impact on daily activities. This questionnaire consists of nine items rated on a seven-point Likert scale, ranging from 1 ('strongly disagree') to 7 ('strongly agree'). The score ranges from 7 (no fatigue in daily activities) to 63 (extreme fatigue in daily activities). A score above 36 indicates that the patient may need to have their fatigue assessed by a healthcare professional.
Measured: At inclusion
Predictive score for return-to-work rate
Develop a predictive score for return to work using the predictive factors for return to work identified in the main objective.
Measured: At inclusion
Job retention
To study job retention and its association with factors such as stroke severity.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start29 Oct 2025
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
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.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise Laclautre, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264387
- Sponsor's protocol ID
- RNI 2025 ORANGE
- Acronym
- RTWS2
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2025
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Return to Work After a First Stroke Treated at Clermont-Ferrand University Hospital in Puy de Dôme Between January 2020 and December 2024
- ClinicalTrials.gov ID
- NCT07264387
- Acronym / sponsor ID
- RTWS2 / RNI 2025 ORANGE
- Conditions
- Stroke
- Keywords
- stroke, return to work, predictive factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 4 Dec 2025 (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.
Stroke is a leading cause of acquired motor disability and the second most common cause of major cognitive impairment worldwide. In France, approximately 150,000 new cases occur annually, with around 31% affecting individuals of working age, making return to work (RTW) a critical public health issue. Beyond the medical burden, stroke has profound socio-economic consequences, including loss of productivity, prolonged sick leave, part-time resumption, and the need for workplace adaptations. While RTW after stroke has been investigated, major gaps remain. No standardized recommendations exist for vocational reintegration, and predictive factors are still debated. Quantitative determinants such as stroke type, severity, functional independence, and occupational characteristics have been identified, but qualitative aspects-including self-efficacy, perceived social burden, employer relationships, and motivation-are poorly documented. Moreover, cognitive deficits are often insufficiently characterized, as screening tools such as MMSE or MoCA lack the sensitivity of comprehensive neuropsychological assessments. The impact of revascularization procedures on RTW and the ability to sustain employment after initial resumption also remain unclear. Importantly, no recent data are available in the Auvergne region, despite evolving labor policies that may influence reintegration trajectories. This observational study therefore aims to identify both quantitative and qualitative predictors of RTW after ischemic or hemorrhagic stroke, describe vocational pathways in a regional cohort, and explore barriers and facilitators to long-term reintegration. Ultimately, the study seeks to provide updated evidence to guide tailored rehabilitation and socio-professional reintegration strategies, supporting sustainable RTW in working-age stroke survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Stroke management follows a continuum, starting with acute care in neurology and neurosurgery, then progressing to medium- and long-term multidisciplinary rehabilitation in the Physical Medicine and Rehabilitation (PMR) department of Clermont-Ferrand University Hospital. Within this context, return to work is a key objective, supported by the expertise of PMR teams and close collaboration with neurology and neurosurgery. To conduct this study, authorisation to access medical records was granted by the Medical Information Department (DIM), covering patients under 64 years old admitted for ischaemic or haemorrhagic stroke between January 2020 and December 2024. Screening will be performed on hospitalisations in neurology and neurosurgery, and all eligible patients experiencing a first stroke during this period will be invited to participate.
Key inclusion criteria (7 listed)
- Patients who have suffered an ischaemic stroke according to ICD-10 (ICD-10 code: I63 (cerebral infarction) I64 (unspecified stroke), I69 (sequelae of cerebrovascular disease) or patients who have had a haemorrhagic stroke according to ICD-10 (ICD-10 code: I60, I61 and I62) between January 2020 and December 2024
- Patients of working age/under 64 years of age (legal retirement age)
- Patients with an employment contract at the time of the stroke
- Patients treated at Clermont-Ferrand University Hospital
- Post-stroke consultation recorded in the patient's medical file
Key exclusion criteria (11 listed)
- Patients with a history of ischaemic or haemorrhagic stroke
- Patients with a history of head trauma with neurological sequelae corresponding to codes S060, S061, S062, S063, S065, S066, S067, S068 and S069
- Patients who died as a result of stroke
- Patients unable to respond to telephone questionnaires
- Patients under guardianship or trusteeship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Return to work rate
Time frame: At inclusion
Percentage of return to work after a first ischaemic or haemorrhagic stroke between January 2020 and December 2024 in patients of working age.
Factors correlated with return to work
Time frame: At inclusion
Determine the factors associated with return to work (gender)
Factors correlated with return to work
Time frame: At inclusion
Determine the factors associated with return to work (stroke severity)
Factors correlated with return to work
Time frame: At inclusion
Determine the factors associated with return to work (stroke type (ischaemic or haemorrhagic)).
Factors correlated with return to work
Time frame: At inclusion
Determine the factors associated with return to work (independence)
Factors correlated with return to work
Time frame: At inclusion
Determine the factors associated with return to work (occupation)
5 secondary outcomes
Quality of life after stroke
Time frame: At inclusion
Anxiety and Depression scale
Time frame: At inclusion
Fatigue Severity Scale
Time frame: At inclusion
Predictive score for return-to-work rate
Time frame: At inclusion
Job retention
Time frame: At 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 9 Oct 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.
Lise Laclautre study director
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospital, Clermont-Ferrand at 2 sites 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 7 inclusion and 11 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Return to work rate (time frame: At inclusion). The study lists 6 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 9 Oct 2026.