A Pilot Return-to-Work Cognitive Intervention After Stroke
NCT07116187, Not applicable, Recruiting, National University of Singapore
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Pilot Return-to-Work Cognitive Intervention After Stroke | ClinicalTrials.gov |
| NCT number | NCT07116187 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | National University of Singapore | ClinicalTrials.gov |
| Conditions | Stroke | ClinicalTrials.gov |
| Interventions | Train-Your-Brain (TYB) Stroke Recovery Programme | ClinicalTrials.gov |
| First posted | 2025-08-11 | ClinicalTrials.gov |
| Last updated | 2025-08-26 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of eligible/ineligible participants | Through study completion, an average of 6 months | Percentage of eligible/ineligible participants and reasons for ineligibility | ClinicalTrials.gov |
| Primary | Recruitment and attrition rates | Through study completion, an average of 6 months | Percentage of recruited participants and drop-outs | ClinicalTrials.gov |
| Primary | VasCog Screen Test | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | Test is comprised of a short-Montreal Cognitive Assessment (total score out of 12) and modified Symbol Digit Modalities Test (score calculated based on correct responses) | ClinicalTrials.gov |
| Primary | Vascular Dementia Battery | Baseline (pre-intervention) | Participants will meet criteria for Mild Cognitive Impairment if there is 1 or more domain(s) with failure in at least 50% of tasks in domain | ClinicalTrials.gov |
| Primary | National Institute of Neurological Disorders and Stroke - Canadian Stroke Network (NINDS-CSN) Stroke Protocol | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | A test battery comprised of cognitive tests that are measured against their respective normative scores | ClinicalTrials.gov |
| Primary | Return-to-work Questionnaire (National Institute of Neurological Disorders and Stroke - Common Data Elements) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | Survey questions of participants' work status before and after stroke with check-box responses | ClinicalTrials.gov |
| Primary | Intervention fidelity | During the intervention and immediately after the intervention | Intervention Fidelity Checklist (eNACT Group Facilitation Competency Checklist) * "Observed - Done well" and "Observed - Done adequately" is equivalent to a score of 2; "Observed - Not done well" is equivalent to a score of 1; "Not observed - despite opportunity" is equivalent to a score of 0 * An overall score of 2 reflects adequate competence in group facilitation | ClinicalTrials.gov |
| Primary | Qualitative interviews | Immediately after the intervention | Semi-structured interviews will be conducted with stroke survivors and family members to obtain feedback about their experiences of the intervention | ClinicalTrials.gov |
| Primary | Participants' acceptability of the intervention | During the intervention | Feedback forms provided after each intervention session rated on a 5-point response scale from Strongly Disagree to Strongly Agree | ClinicalTrials.gov |
| Primary | Patient-Reported Outcomes Measurement Information System (PROMIS) - 10 | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 5-point response scale from Excellent (5) to Poor (1) | ClinicalTrials.gov |
| Primary | EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | Survey questions of participants' Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression with check-box responses across five levels of severity, ranging from no problems to extreme problems. | ClinicalTrials.gov |
| Primary | Fatigue Assessment Scale | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 5-point response scale from Always (5) to Never (1) | ClinicalTrials.gov |
| Primary | Depression, Anxiety, Stress Scale | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 3-point response scale from Did not apply to me at all (0) to Applied to me very much, or most of the time (3) | ClinicalTrials.gov |
| Primary | Zarit Burden Interview | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 4-point response scale from Nearly Always (4) to Never (0) | ClinicalTrials.gov |
| Primary | Voils Domains Of Subjective Extent of Nonadherence | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | Survey questions on participants' extent and reasons for nonadherence with check-box responses (None of the time, A little of the time, Some of the time, Most of the time, Every time) | ClinicalTrials.gov |
| Primary | Blood Pressure Measurement | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | Measurement of participants' blood pressure reading | ClinicalTrials.gov |
| Primary | Blood-Derived Neurotrophic Factor | Immediately after the intervention, 6-months follow-up | Blood biomarker derived from participants' blood samples | ClinicalTrials.gov |
| Primary | Functional near-infrared spectroscopy measurement | Immediately after the intervention, 6-months follow-up | Measurement of oxyhaemoglobin (HbO2), deoxyheemoglobin (HbR), and regional oxygen saturation (rSO2) while participants undergo various cognitive tests (e.g. N-back Task, verbal fluency test, Stroop Task) | ClinicalTrials.gov |
| Secondary | Cost Effectiveness Analysis Questionnaire | Immediately after the intervention, 6-months follow-up | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| 2-Back Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)