Immersive Virtual Environments and Wearable Haptic Devices in rehabilitation of children with neuromotor impairments: a single-blind randomized controlled crossover pilot study

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Abstract

Background

The past decade has seen the emergence of rehabilitation treatments using virtual reality. One of the advantages in using this technology is the potential to create positive motivation, by means of engaging environments and tasks shaped in the form of serious games. The aim of this study is to determine the efficacy of immersive Virtual Environments and weaRable hAptic devices (VERA) for rehabilitation of upper limb in children with Cerebral Palsy (CP) and Developmental Dyspraxia (DD).

Methods

A two period cross-over design was adopted for determining the differences between the proposed therapy and a conventional treatment. Eight children were randomized into two groups: one group received the VERA treatment in the first period and the manual therapy in the second period, and viceversa for the other group. Children were assessed at the beginning and the end of each period through both the Nine Hole Peg Test (9-HPT, primary outcome) and Kinesiological Measurements obtained during the performing of similar tasks in a real setting scenario (secondary outcomes).

Results

All subjects, not depending from which group they come from, significantly improved in both the performance of the 9-HPT and in the parameters of the kinesiological measurements (movement error and smoothness). No statistically significant differences have been found between the two groups.

Conclusions

These findings suggest that immersive VE and wearable haptic devices is a viable alternative to conventional therapy for improving upper extremity function in children with neuromotor impairments.

Trial registration ClinicalTrials, NCT03353623. Registered 27 November 2017-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03353623

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Most cited references 36

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CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Sandra M. Eldridge, Claire L Chan, Michael J Campbell … (2017)

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites. Electronic supplementary material The online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.

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Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle.

Gustavo Saposnik, Robert Teasell, Muhammad Mamdani … (2010)

Hemiparesis resulting in functional limitation of an upper extremity is common among stroke survivors. Although existing evidence suggests that increasing intensity of stroke rehabilitation therapy results in better motor recovery, limited evidence is available on the efficacy of virtual reality for stroke rehabilitation. In this pilot, randomized, single-blinded clinical trial with 2 parallel groups involving stroke patients within 2 months, we compared the feasibility, safety, and efficacy of virtual reality using the Nintendo Wii gaming system (VRWii) versus recreational therapy (playing cards, bingo, or "Jenga") among those receiving standard rehabilitation to evaluate arm motor improvement. The primary feasibility outcome was the total time receiving the intervention. The primary safety outcome was the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, was evaluated with the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at 4 weeks after intervention. Overall, 22 of 110 (20%) of screened patients were randomized. The mean age (range) was 61.3 (41 to 83) years. Two participants dropped out after a training session. The interventions were successfully delivered in 9 of 10 participants in the VRWii and 8 of 10 in the recreational therapy arm. The mean total session time was 388 minutes in the recreational therapy group compared with 364 minutes in the VRWii group (P=0.75). There were no serious adverse events in any group. Relative to the recreational therapy group, participants in the VRWii arm had a significant improvement in mean motor function of 7 seconds (Wolf Motor Function Test, 7.4 seconds; 95% CI, -14.5, -0.2) after adjustment for age, baseline functional status (Wolf Motor Function Test), and stroke severity. VRWii gaming technology represents a safe, feasible, and potentially effective alternative to facilitate rehabilitation therapy and promote motor recovery after stroke.

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First Person Experience of Body Transfer in Virtual Reality

Mel Slater, Bernhard Spanlang, Maria V. Sanchez-Vives … (2010)

Background Altering the normal association between touch and its visual correlate can result in the illusory perception of a fake limb as part of our own body. Thus, when touch is seen to be applied to a rubber hand while felt synchronously on the corresponding hidden real hand, an illusion of ownership of the rubber hand usually occurs. The illusion has also been demonstrated using visuomotor correlation between the movements of the hidden real hand and the seen fake hand. This type of paradigm has been used with respect to the whole body generating out-of-the-body and body substitution illusions. However, such studies have only ever manipulated a single factor and although they used a form of virtual reality have not exploited the power of immersive virtual reality (IVR) to produce radical transformations in body ownership. Principal Findings Here we show that a first person perspective of a life-sized virtual human female body that appears to substitute the male subjects' own bodies was sufficient to generate a body transfer illusion. This was demonstrated subjectively by questionnaire and physiologically through heart-rate deceleration in response to a threat to the virtual body. This finding is in contrast to earlier experimental studies that assume visuotactile synchrony to be the critical contributory factor in ownership illusions. Our finding was possible because IVR allowed us to use a novel experimental design for this type of problem with three independent binary factors: (i) perspective position (first or third), (ii) synchronous or asynchronous mirror reflections and (iii) synchrony or asynchrony between felt and seen touch. Conclusions The results support the notion that bottom-up perceptual mechanisms can temporarily override top down knowledge resulting in a radical illusion of transfer of body ownership. The research also illustrates immersive virtual reality as a powerful tool in the study of body representation and experience, since it supports experimental manipulations that would otherwise be infeasible, with the technology being mature enough to represent human bodies and their motion.

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Author and article information

Contributors

Ilaria Bortone:

ORCID: http://orcid.org/0000-0002-4767-5334

ilariabortone@gmail.com

Luca Bonfiglio: l.bonfiglio@ao-pisa.toscana.it

Antonio Frisoli: antonio.frisoli@santannapisa.it

Journal

Journal ID (nlm-ta): J Neuroeng Rehabil

Journal ID (iso-abbrev): J Neuroeng Rehabil

Title: Journal of NeuroEngineering and Rehabilitation

Publisher: BioMed Central (London )

ISSN (Electronic): 1743-0003

Publication date (Electronic): 28 October 2020

Publication date PMC-release: 28 October 2020

Publication date Collection: 2020

Volume: 17

Electronic Location Identifier: 144

Affiliations

[1 ]GRID grid.5326.2, ISNI 0000 0001 1940 4177, Institute of Clinical Physiology (IFC), , National Research Council (CNR), ; Pisa, Italy

[2 ]GRID grid.263145.7, ISNI 0000 0004 1762 600X, PERCRO Laboratory, , Scuola Superiore Sant’Anna, ; Pisa, Italy

[3 ]GRID grid.144189.1, ISNI 0000 0004 1756 8209, Unit of Developmental Neurorehabilitation, Maternal and Child Department, , Pisa University Hospital, ; Pisa, Italy

Author information

Ilaria Bortone http://orcid.org/0000-0002-4767-5334

Article

Publisher ID: 771

DOI: 10.1186/s12984-020-00771-6

PMC ID: 7594483

PubMed ID: 33115487

SO-VID: a65baa2e-0e7e-4507-b554-8bdbaaa9b260

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 10 December 2019

Date accepted : 12 October 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100011273, Project TELOS - Tailored neurorehabilitation thErapy via multi-domain data anaLytics and adapative seriOus games for children with cerebral palSy;

Award ID: CUP J52F20001040002

Award Recipient : Antonio Frisoli

Custom metadata

ScienceOpen disciplines: Neurosciences

Keywords: virtual reality,human motion analysis,rehabilitation,tactile feedback,serious game

Data availability:

ScienceOpen disciplines: Neurosciences

Keywords: virtual reality, human motion analysis, rehabilitation, tactile feedback, serious game

Immersive Virtual Environments and Wearable Haptic Devices in rehabilitation of children with neuromotor impairments: a single-blind randomized controlled crossover pilot study

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Music and Mental Imagery

Most cited references 36

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle.

First Person Experience of Body Transfer in Virtual Reality

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