Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jul 16;20(1):436.
doi: 10.1186/s13063-019-3396-2.

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

Natalia Araujo Mazzini  1 , Murilo Groschitz Ruas Almeida  1 , José Eduardo Pompeu  2 , Janaine Cunha Polese  3 , Camila Torriani-Pasin  4
Affiliations

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

Natalia Araujo Mazzini et al. Trials. .

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.

Keywords: Physical exercises; Quality of life.; Stroke; Virtual reality.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) flow diagram
Fig. 2
Fig. 2
Virtual reality games selected for the odd-game sessions and individuals’ practice
Fig. 3
Fig. 3
Virtual reality games selected for the even-game sessions and individuals’ practice
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Gordon NF, Gulanick M, Costa F, Fletcher G, Franklin BA, Roth EJ, et al. Physical activity and exercise recommendations for stroke survivors: an American Heart Association scientific statement from the Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Circulation. 2004;109(16):2031–2041. doi: 10.1161/01.CIR.0000126280.65777.A4. - DOI - PubMed
    1. Saltychev M, Sjögren T, Bärlund E, Laimi K, Paltamaa J. Do aerobic exercises really improve aerobic capacity of stroke survivors? A systematic review and meta-analysis. Eur J Phys Rehabil Med. 2016;52(2):233–243. - PubMed
    1. Lee NK, Kwon JW, Son SM, Kang KW, Kim K, Hyun-Nam S. The effects of closed and open kinetic chain exercises on lower limb muscle activity and balance in stroke survivors. NeuroRehabilitation. 2013;33(1):177–83. - PubMed
    1. Ouellette MM, LeBrasseur NK, Bean JF, Phillips E, Stein J, Frontera WR, et al. High-intensity resistance training improves muscle strength, self-reported function, and disability in long-term stroke survivors. Stroke. 2004;35(6):1404–1409. doi: 10.1161/01.STR.0000127785.73065.34. - DOI - PubMed
    1. Shin WS, Lee SW, Lee YW, Choi SB, Song CH. Effects of combined exercise training on balance of hemiplegic stroke patients. J Phys Ther Sci. 2011;23(4):639–643. doi: 10.1589/jpts.23.639. - DOI

Publication types