Effectiveness of dose-matched immersive virtual reality-stationary cycling combined with neurological physiotherapy versus neurological physiotherapy alone in individuals with chronic stroke (CIVIS): A single-blind, randomized crossover trial protoco

BACKGROUND: Stroke is a leading cause of long-term disability worldwide and frequently results in persistent motor and functional impairments, particularly affecting gait and balance. Given the high prevalence and impact of these limitations on independence and quality of life, innovative rehabilitation strategies are needed. Immersive virtual reality combined with stationary cycling (IVR-SC) has emerged as an innovative rehabilitation approach with the potential to improve mobility and functional outcomes after stroke. AIM: To analyze the comparative effectiveness of two dose-matched programs, one combining IVR-SC plus neurological physiotherapy (NP), versus the other consisting of NP alone, in individuals with chronic stroke. METHODS: A randomized, single-blind, crossover clinical trial will be conducted. After calculating the sample size, a minimum of 8 participants with chronic stroke (≥6 months), hemiparesis, and gait and balance impairments will be randomly assigned to one of two sequences of intervention. Each participant will receive both neurological physiotherapy and IVR-SC across two 4-week intervention periods separated by a washout period (4 weeks). Each intervention period consists of 8 sessions delivered over a 4-week period, with each session lasting 60 minutes. The primary outcome will be gait quality, assessed using Wisconsin Gait Scale (WGS), while secondary outcomes will include walking endurance, balance, motor function, and muscle tone. Clinical outcomes will be assessed at baseline and after each intervention period. Satisfaction with using the IVR-SC intervention will also be evaluated. Statistical analyses will follow an intention-to-treat approach using a linear mixed-effects model (LMM) with treatment, period, sequence, baseline, and center as fixed effects, and participant as a random effect. Statistical significance will be set at p < 0.05. An individual responder analysis will be performed to determine if participants exceeded the minimal clinically important difference (MCID) of 2.25 points on the WGS. DISCUSSION: This study will contribute to understanding the potential comparative effects of IVR-SC in stroke rehabilitation. Given the heterogeneity of individuals with stroke, which may limit the conclusiveness of findings in parallel-group studies, the crossover design allows each participant to serve as their own control, reducing inter-individual variability and strengthening the interpretation of the results. If effective, IVR-SC could represent a feasible and scalable option for partially replacing NP within standard neurorehabilitation, with potential for implementation in both clinical and home-based settings. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT07529665. Effectiveness of dose-matched rehabilitation with immersive virtual reality-stationary cycling combined with neurological physiotherapy versus neurological physiotherapy alone in individuals with chronic stroke (CIVIS): study protocol for a single-blind, randomized crossover trial. URL: https://clinicaltrials.gov/study/NCT07529665. Date of registration: 2026-04-14. Version 1.