StrokeNCT06842420
Model Development and Temporal Validation of the Predictive Factors for Return to Work After Stroke Rehabilitation
An observational study of Stroke, run by Changi General Hospital at 1 site in Singapore.
Trial summary
The purpose of the study is to develop a predictive model for return to work after stroke rehabilitation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- How many people
- 1,375 participants
- Where
- 1 siteSingapore
- Study dates
- 5 Oct 2023to 31 Mar 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The criteria for recruitment is first-ever stroke and premorbid work.
Who may be able to join
- Completed inpatient stroke rehabilitation in CGH
- Diagnosis of a first ever stroke
- Patients who were working prior to stroke
- Consent given
Who cannot join
- Not first ever stroke
- Did not require inpatient stroke rehabilitation
- Not working prior to stroke
- No consent obtained
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of the study is to develop a predictive model for return to work after stroke rehabilitation.
Read the detailed description
Background Return to work post stroke is a key milestone for many survivors of stroke; however, many cannot achieve this goal. Based on the previous work by Tay et al, independent predictive factors were identified for return to work post inpatient stroke rehabilitation. In further works by Koh and Tay with the same dataset put through different models such as LASSO-Full, Lasso-Routine, ElasticNet-Full, etc suggests that the good discrimination performance of the return-to-work prediction models during internal validation supports a multisite, external validation study. Performing a temporal validation study is the interim step. A smaller part of the dataset could be used to further train the development model.
Significant economic costs are incurred because of stroke, which do not include further economic costs from the downstream loss of earnings and caregiver burden. Existing prediction models of return-to-work have area under the receiver operating characteristic curves (AUROCs) between 0.65 and 0.80. However, these models have not been assessed for calibration or clinical utility. No externally validated prediction model exists for return-to-work after stroke. There are advantages to having a prediction model. One of the concerns of patients and their families involve the loss of income as a result of stroke. The prediction model would help to prognosticate, as well as assist to set appropriate rehabilitation goals for the patient. Suitable patients can be directed to return to work services, if necessary.
Health is related to one's employment and financial position. Being able to return to gainful employment can result in better general and mental health5. People with disabilities employed in the past year reported better general and mental health than their peers with the same disabilities who were unemployed.
This study could be completed in 1 to 2 years and a prospective study involving external validation can be simultaneously performed with NUHS collaborators over 2 to 2.5 years. Both projects could be published in the next 2 to 3 years upon obtaining the grant for the temporal validation study. Thereafter, a Return to work calculator could be designed and launched in the next 4 years.
Hypothesis This study seeks to collect 1375 patient data who had completed inpatient stroke rehabilitation between the time periods of 2018-2025. We seek to further train our development model and to perform a temporal validation on this model.
- Conditions
- Stroke
- Keywords
- return to work, stroke rehabilitation, stroke, model development, temporal validation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients who had completed inpatient stroke rehabilitation between 2018-2025 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work
Return to work at 1 year and 2 years post stroke
Measured: 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start5 Oct 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,375 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842420
- Sponsor's protocol ID
- 2023/2526
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is protected under the SingHealth Data Protection Policy which is compliant to the Singapore Personal Data Protection Act 2012
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model Development and Temporal Validation of the Predictive Factors for Return to Work After Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT06842420
- Acronym / sponsor ID
- 2023/2526
- Conditions
- Stroke
- Keywords
- return to work, stroke rehabilitation, stroke, model development, temporal validation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,375 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Feb 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.
The purpose of the study is to develop a predictive model for return to work after stroke rehabilitation.
Detailed description
Background Return to work post stroke is a key milestone for many survivors of stroke; however, many cannot achieve this goal. Based on the previous work by Tay et al, independent predictive factors were identified for return to work post inpatient stroke rehabilitation. In further works by Koh and Tay with the same dataset put through different models such as LASSO-Full, Lasso-Routine, ElasticNet-Full, etc suggests that the good discrimination performance of the return-to-work prediction models during internal validation supports a multisite, external validation study. Performing a temporal validation study is the interim step. A smaller part of the dataset could be used to further train the development model.
Significant economic costs are incurred because of stroke, which do not include further economic costs from the downstream loss of earnings and caregiver burden. Existing prediction models of return-to-work have area under the receiver operating characteristic curves (AUROCs) between 0.65 and 0.80. However, these models have not been assessed for calibration or clinical utility. No externally validated prediction model exists for return-to-work after stroke. There are advantages to having a prediction model. One of the concerns of patients and their families involve the loss of income as a result of stroke. The prediction model would help to prognosticate, as well as assist to set appropriate rehabilitation goals for the patient. Suitable patients can be directed to return to work services, if necessary.
Health is related to one's employment and financial position. Being able to return to gainful employment can result in better general and mental health5. People with disabilities employed in the past year reported better general and mental health than their peers with the same disabilities who were unemployed.
This study could be completed in 1 to 2 years and a prospective study involving external validation can be simultaneously performed with NUHS collaborators over 2 to 2.5 years. Both projects could be published in the next 2 to 3 years upon obtaining the grant for the temporal validation study. Thereafter, a Return to work calculator could be designed and launched in the next 4 years.
Hypothesis This study seeks to collect 1375 patient data who had completed inpatient stroke rehabilitation between the time periods of 2018-2025. We seek to further train our development model and to perform a temporal validation on this model.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients who had completed inpatient stroke rehabilitation between 2018-2025 | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The criteria for recruitment is first-ever stroke and premorbid work.
Key inclusion criteria (4 listed)
- Completed inpatient stroke rehabilitation in CGH
- Diagnosis of a first ever stroke
- Patients who were working prior to stroke
- Consent given
Key exclusion criteria (4 listed)
- Not first ever stroke
- Did not require inpatient stroke rehabilitation
- Not working prior to stroke
- No consent obtained
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
Time frame: 1 year and 2 years
Return to work at 1 year and 2 years post stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No. Data is protected under the SingHealth Data Protection Policy which is compliant to the Singapore Personal Data Protection Act 2012
Related trials for Stroke
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Changi General Hospital at 1 site in Singapore.
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: enrolling by invitation, as of the sponsor's last update on 24 Feb 2025. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: 1 year and 2 years). 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 24 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.