A Pilot Return-to-Work Cognitive Intervention After Stroke

NCT ID: NCT07116187

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-08
• Study Completion Date: 2026-12-31

Brief Summary

This study addresses the growing burden of stroke in Singapore and highlights the lack of rehabilitation services for return to work after stroke. Despite functional physical recovery, many stroke survivors experience persistent impairments that hinder return-to-work. To bridge this gap, the study will implement a community-based brain health programme targeting cognitive and vocational outcomes in stroke survivors. Caregivers will also be included due to their critical support role. The study will assess the intervention's feasibility, acceptability, and its impact on cognitive function, return-to-work, neuroplasticity, psychosocial health, fatigue, and self-care.

Detailed Description

Stroke is the fourth leading cause of death and the leading cause of adult disability in Singapore. Statistics indicate a concerning rise in young stroke cases. The burden of stroke care is expected to increase exponentially, posing significant challenges to the healthcare system and society. Cognitive impairment after stroke has been documented in up to one-third of stroke survivors. These impairments may be subtle but persistent and progressive even after the stroke survivor appears to have made functional recovery in other areas. Existing services in Singapore for stroke survivors typically target physical and daily functioning outcomes with little focus on cognitive functioning. Moreover, there is a lack of services for stroke survivors who face difficulties in returning to work due to cognitive impairment even when they have achieved optimal physical recovery. An important assessment of a rehabilitation intervention programme is in examining whether it drives positive neuroplasticity, which leads to improved cognitive and functional outcomes. There is presently a dearth of literature in brain mechanisms underlying the impact of cognitive rehabilitation.

A community-based brain health intervention, the Train-Your-Brain Stroke Recovery Programme, will be delivered by registered clinical neuropsychologists. Designed to enhance cognitive function and return-to-work outcomes in stroke survivors with mild cognitive impairment, the intervention will be evaluated using a mixed-methods randomized controlled trial. Stroke survivors will be randomized 1:1 into either the intervention or control arm. Caregivers, given their critical support role, will also be recruited to participate in the study. Outcome measures include feasibility of intervention, acceptability of intervention, cognitive function, return-to-work outcomes, changes in biomarkers, neuroimaging findings, psychosocial health, fatigue, and self-care. Outcome measures will be conducted pre-intervention, post-intervention, and 6-month follow-up.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Intervention Arm

Participants will undergo the group-based Train-Your-Brain Stroke Recovery Programme.

Group Type: EXPERIMENTAL

Train-Your-Brain (TYB) Stroke Recovery Programme

Intervention Type: OTHER

The intervention involves a structured brain health programme delivered by clinical neuropsychologists in three phases: an initial needs assessment, a multi-session intervention, and follow-up support. Participants will receive assessments, attend group sessions covering topics such as lifestyle, mood, cognition, and return-to-work strategies, and be supported with workbooks and referrals to community services. The programme combines in-person and online formats.

Control Arm

Participants will undergo treatment-as-usual from their respective treatment providers.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Train-Your-Brain (TYB) Stroke Recovery Programme

The intervention involves a structured brain health programme delivered by clinical neuropsychologists in three phases: an initial needs assessment, a multi-session intervention, and follow-up support. Participants will receive assessments, attend group sessions covering topics such as lifestyle, mood, cognition, and return-to-work strategies, and be supported with workbooks and referrals to community services. The programme combines in-person and online formats.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between 21 to 65 years old
• Ability to provide informed consent
• Consent to recording / photo-taking
• Living in the community with at least three months after stroke
• Looking to return to work or switch jobs after stroke
• No significant aphasia or physical disability issues which will impede them from performing cognitive tasks in the interventions and assessments
• No major psychiatric illnesses
• Able to understand and converse in English
• Score on MoCA ≤22 and/or SDMT ≤13 (for those educated ≤6 years) or SDMT ≤32 (for those educated >6 years)
• Meet criteria for Mild Cognitive Impairment based on the Vascular Dementia Battery

• At least 21 years old
• Ability to provide informed consent
• Consent to recording / photo-taking
• Staying with or having knowledge of the stroke survivor's functioning
• No major psychiatric illnesses
• Able to understand and converse in English

Exclusion Criteria

• Less than 21 years old
• More than 65 years old
• Unable to provide informed consent
• Refuse recording
• Not living in the community and having less than three months after stroke
• Significant aphasia or physical disability issues which will impede them from performing cognitive tasks in the interventions and assessments
• Major psychiatric illnesses
• Not able to understand and converse in English

• Less than 21 years old
• Unable to provide informed consent
• Refuse recording
• Not staying with or not having knowledge of the stroke survivor's functioning
• Major psychiatric illnesses
• Not able to understand and converse in English

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Singapore

OTHER

Sponsor Role: lead

Responsible Party

Catherine Yanhong Dong, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National University of Singapore

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Yanhong Dong

Role: CONTACT

nurdy@nus.edu.sg

65-65168686

Facility Contacts

Yanhong Dong, PhD

Role: primary

nurdy@nus.edu.sg

+65 6516 8686

Other Identifiers

NUS-IRB-2025-223

Identifier Type: -

Identifier Source: org_study_id