StrokeCog-R: Protocol for a Pilot Randomised Controlled Trial Of A Novel Cognitive Rehabilitation Intervention For Post-Stroke Cognitive Impairment

Abstract Background Post-stroke cognitive impairment (PSCI) affects 50% of patients six months post-stroke and is associated with increased disability, reduced quality of life, diminished independence, and a higher risk of long-term care and dementia. Addressing cognitive impairment is crucial to maximise patient recovery, facilitate the return to pre-stroke activities, and optimise secondary prevention efforts. However, cognitive rehabilitation is underrepresented in standard stroke rehabilitation protocols. This pilot randomised controlled trial (RCT) aims to evaluate a novel cognitive rehabilitation intervention, StrokeCog-R, designed to enhance cognitive function in stroke survivors with PSCI. The primary aims are to assess the feasibility of patient recruitment and retention and to determine the statistical power needed for a definitive trial. A secondary aim is to evaluate the efficacy and acceptability of the intervention for individuals with mild-to-moderate PSCI. Methods Sixty-four consecutive stroke patients with mild-to-moderate PSCI will be recruited and randomly assigned to either the intervention group (StrokeCog-R) or the control group (usual care). The intervention involves five weeks of group-based cognitive rehabilitation using “Rehearsal-Based” and “Compensatory-Based” strategies, supplemented with tailored home activities. Cognitive function, self-efficacy, and caregiver psychological wellbeing will be assessed pre- and post-intervention (or control) and at a four-month follow-up. Intervention acceptability will be documented through focus groups following each intervention. Recruitment is ongoing, and the first intervention group has concluded. Results Recruitment and retention rates, the feasibility of randomisation, patient acceptability, and resource utilisation will be evaluated. Additionally, the effectiveness of various communication techniques for retaining participants between the intervention period and the four-month follow-up will be assessed. These data will inform recruitment strategies and the determination of necessary effect sizes to power a definitive trial. Conclusion This study will provide critical insights for a definitive trial, potentially making a substantial contribution to the evidence base for cognitive rehabilitation in stroke patients.