A structured music-based intervention for motor rehabilitation and exploratory cognitive and quality-of-life outcomes after stroke: a study protocol for a randomized waitlist-controlled intervention study.

Background: Stroke is one of the leading causes of long-term disability and is frequently associated with persistent motor, cognitive, emotional, and social sequelae that affect autonomy and quality of life. Music-based interventions have shown potential benefits in post-stroke rehabilitation, particularly through rhythmic auditory stimulation, structured instrumental practice, and active musical engagement. These approaches may support motor coordination and motivation and may also contribute to emotional regulation, social interaction, and perceived quality of life. However, evidence remains limited regarding structured music-based interventions that integrate motor activities with broader cognitive and psychosocial components into post-stroke rehabilitation. This randomized waitlist-controlled intervention study aims to evaluate the effects of a structured music-based intervention on motor function after stroke, with executive functioning and stroke-specific quality of life being examined as exploratory outcomes. Methods: A prospective, phased, randomized waitlist-controlled intervention study will include adults aged 18-70 years who have experienced a stroke at least 3 months before enrollment. The first recruitment phase will be conducted in a single outpatient neurological rehabilitation center in the Community of Madrid, Spain, with subsequent recruitment phases planned at additional outpatient neurological rehabilitation centers within the Community of Madrid until the required sample size is achieved. Two groups will be formed: an experimental group receiving standard rehabilitation care plus a structured music-based intervention consisting of 10 sessions and a waitlist group receiving only standard rehabilitation care during this period, followed by the structured music-based intervention. Assessments will be carried out at week 0 (baseline), week 5 (post-intervention), and week 10 (after group crossover), with an additional follow-up at 3 months. The primary outcome will be motor function. Upper-limb motor function will be assessed as a secondary motor outcome, while executive functioning and stroke-specific quality of life will be examined as exploratory outcomes. Analyses will follow the intention-to-treat principle, with additional analyses conducted for participants completing at least 80% of sessions. A linear mixed-effects model will be used to estimate the main effect of the intervention on the primary motor outcome, with additional secondary and exploratory models performed for upper-limb motor function, executive functioning, and stroke-specific quality of life. The model will include time, group, and the interaction between group and time as fixed effects, with time since stroke included as a covariate. Additional analyses will be conducted using intraclass correlation coefficients to explore the agreement between participant and family member reports of executive function. Discussion: This protocol will evaluate a structured music-based intervention as a complement to standard rehabilitation care, with a primary focus on motor rehabilitation. Exploratory analyses will examine whether the intervention is associated with changes in executive functioning and stroke-specific quality of life. The study is expected to provide preliminary evidence on the feasibility and potential effects of this integrative music-based intervention within post-stroke rehabilitation and to contribute to the development of multidomain rehabilitation approaches. The findings may inform the design of future studies and the potential implementation of music-based interventions in post-stroke rehabilitation settings. Study protocol preregistration: https://osf.io/hqruw.