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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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.

Singapore1 site
  • Changi General Hospital

    Singapore, Singapore, 529889

Other trials in Singapore

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 groups in NCT06842420
Study groupRoleWhat they receive
Stroke patients who had completed inpatient stroke rehabilitation between 2018-2025Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted24 Feb 2025
  2. Study start5 Oct 2023
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

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
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

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.

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