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  • Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke (RHOMBUS): protocol of an intervention feasibility trial

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Neurology
Protocol
Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke (RHOMBUS): protocol of an intervention feasibility trial
  1. Cherry Kilbride1,
  2. Daniel J M Scott1,
  3. Tom Butcher1,
  4. Meriel Norris1,
  5. Jennifer M Ryan1,2,
  6. Nana Anokye1,
  7. Alyson Warland1,
  8. Karen Baker1,
  9. Dimitrios A Athanasiou3,
  10. Guillem Singla-Buxarrais3,
  11. Alexander Nowicky4
  1. 1 Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University, London, UK
  2. 2 Department of Epidemiology and Public Health Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland
  3. 3 Neurofenix, London, UK
  4. 4 Centre for Cognitive Neuroscience, College of Health and Life Sciences, Brunel University, London, UK
  1. Correspondence to Dr Cherry Kilbride; Cherry.Kilbride{at}brunel.ac.uk

Abstract

Introduction Effective interventions to promote upper-limb recovery poststroke are characterised by intensive and repetitive movements. However, the repetitive nature of practice may adversely impact on adherence. Therefore, the development of rehabilitation devices that can be used safely and easily at home, and are motivating, enjoyable and affordable is essential to the health and well-being of stroke survivors.

The Neurofenix platform is a non-immersive virtual reality device for poststroke upper-limb rehabilitation. The platform uses a hand controller (a NeuroBall) or arm bands (NeuroBands) that facilitate upper-limb exercise via games displayed on a tablet. The Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke trial aims to determine the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper-limb poststroke.

Methods and analysis Thirty people poststroke will be provided with a Neurofenix platform, consisting of a NeuroBall or NeuroBands (dependent on impairment level), seven specially designed games, a tablet and handbook to independently exercise their upper limb for 7 weeks. Training commences with a home visit from a research therapist to teach the participant how to safely use the device. Outcomes assessed at baseline and 8 weeks and 12 weeks are gross level of disability, pain, objectively measured arm function and impairment, self-reported arm function, passive range of movement, spasticity, fatigue, participation, quality of life (QOL) and health service use. A parallel process evaluation will assess feasibility, acceptability and safety of the intervention through assessment of fidelity to the intervention measured objectively through the Neurofenix platform, a postintervention questionnaire and semistructured interviews exploring participants’ experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on QOL and resource use.

Ethics and dissemination Ethics approval granted from Brunel University London (10249-MHR-Mar/2018-12322-2). Trial results will be submitted for publication in journals, presented at national and international conferences and distributed to people with stroke.

Trial registration number ISRCTN60291412; Pre-results.

  • stroke
  • rehabilitation
  • feasibility
  • upper extremity/limb
  • gaming
  • virtual reality

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-026620

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    Footnotes

    • Contributors All authors listed meet the International Committee of Medical Journal Editors criteria for authorship. CK and GSB conceived the study, DJMS, TB, AN, JMR, NA, AW and MN designed the study. GSB, DAA, DJMS, TB and CK designed the intervention. CK will lead the running of the trial. DJMS and TB will lead the collection, management and analysis of the data. KB will lead blinded ARAT assessment. MN will lead the process evaluation. JMR will lead the statistical analysis. NA will lead the evaluation of the feasibility of the economic evaluation. All authors have read and approved the final manuscript.

    • Funding This work was supported by Innovate UK grant number 104188[3463]. The study sponsor is Brunel University London. Contact: Professor Peter Hobson, University Research Ethics Committee Chair (peter.hobson@brunel.ac.uk), Brunel University London, London.

    • Disclaimer Neurofenix has no influence on the design of the study, data collection, analysis and interpretation of the data and in writing the manuscript.

    • Competing interests GSB and DAA are employed by Neurofenix (UK), a company that manufactures and markets home-based training solutions. Neurofenix will provide the Neurofenix platforms and technical support to the research therapists.

    • Patient consent Obtained.

    • Ethics approval Ethics approval Ethical approval has been granted by the College of Health and Life Sciences Research Ethics Committee (REC) in Brunel University London (10249-MHR-Mar/2018-12322-2).

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Data sharing statement Pseudonymised data will be made available in a public repository once the data have obtained validation through publication.