Effect of a digital resilience-based course-game sequential intervention on social participation in stroke survivors with limb dysfunction: a randomised controlled trial protocol

基于数字韧性的课程游戏序列干预对肢体功能障碍卒中幸存者社会参与的影响:一项随机对照试验方案

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Abstract

INTRODUCTION: Impairments in social participation are highly prevalent after stroke and are strongly associated with diminished quality of life. Existing interventions have demonstrated limited effectiveness, often focusing predominantly on physical functional training while neglecting the critical psychological and behavioural processes necessary for a successful transition from physical recovery to community reintegration. Furthermore, traditional models relying on face-to-face delivery suffer from poor accessibility, particularly in contexts with unevenly distributed rehabilitation resources. This study aims to evaluate the effect of a digital resilience-based course-game sequential intervention on improving social participation among stroke survivors with limb dysfunction. METHODS AND ANALYSIS: This study is a single-centre, assessor-blinded, two-arm randomised controlled trial. A total of 152 stroke survivors with limb dysfunction will be recruited from three rehabilitation wards of a single tertiary rehabilitation hospital and randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive a digital resilience-based course-game sequential intervention, which is designed to first impart knowledge and skills through the course, followed by their application and reinforcement in the game context to facilitate behaviour transfer, over a 7-week period. The control group will receive a structured, attention-matched control condition comprising digitally delivered general health education materials. The primary outcome is social participation assessed immediately post-intervention using the Frequency subscale of the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P). Secondary outcomes include resilience, exercise adherence, physical function, social network and life-space mobility. All outcomes will be measured at baseline, immediately post-intervention and at 3-month post-intervention. All analyses will follow the intention-to-treat principle. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Shanghai First Rehabilitation Hospital (YK-2025-03-011). Trial findings will be disseminated via peer-reviewed publications and conference presentations. If the intervention is effective, the research team aims to further implement the intervention as usual care within the participating services and beyond. TRIAL REGISTRATION NUMBER: ChiCTR2500110444.

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