A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial

Abstract

Background Multimodal physical exercises already have well-established benefits for the post-stroke population that influence gait functional capacity, balance, gait, cognition, and quality of life. This type of intervention can be performed in both real and virtual environments. Considering the characteristics of both environments, it is questioned to what extent the combination of interventions in real and virtual environments could result in improvement in post-stroke impairments. Methods/design We will conduct a randomized clinical trial with three groups: a real multimodal group (RMG), a virtual multimodal group (VMG), and a combined multimodal group (CMG). It was estimated that we will need a sample of 36 participants (12 per group). RMG individuals will only perform multimodal physical exercises in a real environment two times per week for 60 min per session for 15 weeks. VMG individuals will perform exercises of the same duration over the same time frame but only in a virtual environment. CMG individuals will hold a weekly session in a real environment and another weekly session in virtual environment. The primary outcome measure will be health-related quality of life, evaluated using the Stroke Impact Scale; effects on cognition (Montreal Cognitive Assessment), balance (Berg Balance Scale), mobility (Timed Up & Go), self-selected gait speed (10-meter walk test), and gait functional capacity (6-min walk test) will be investigated as secondary outcome measures. Participants will be evaluated before the beginning of the intervention, immediately after the end of the intervention, and at 1-month follow-up without exercise. If the data meet the assumptions of the parametric analysis, the results will be evaluated by analysis of variance (3 × 3) for the group factor, with repeated measures while taking into account the time factor. The post hoc Tukey test will be used to detect differences (α = 0.05). Discussion This study represents the first clinical trial to include three groups considering physical exercise in real and virtual environments, isolated and combined, that counterbalances the intensity and volume of training in all groups. This study also includes a control of progression in all groups along the 15-week intervention. The outcome measures are innovative because, according to International Classification of Functioning, Disability and Health, activity and participation are the targets for effectiveness evaluation. Trial registration Combinação de exercícios físicos multimodais em ambientes real e virtual para indivíduos pós acidente vascular cerebral crônico, RBR-4pt72m . Registered on 29 August 2016. Electronic supplementary material The online version of this article (10.1186/s13063-019-3396-2) contains supplementary material, which is available to authorized users.

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