The feasibility and acceptability of virtual reality gaming technologies for upper-limb stroke rehabilitation: A mixed-methods study

This thesis was submitted for the award of Doctor of Philosophy and was awarded by Brunel University LondonBackground: Evaluation of virtual-reality gaming technologies for upper-limb stroke rehabilitation has focused on those with mild to moderate impairment. This mixed-methods study details the development and evaluation of the feasibility, acceptability and preliminary efficacy of the custom-developed, Personalised Stroke Therapy (PST) system, in strokesurvivors with mild to moderately-severe levels of impairment. Methods: The PST system was iteratively designed with input from stakeholders. Twelve stroke-survivors (nine females, mean age 58 years, median stroke chronicity 42 months, stroke severity 14-25 for shoulder and elbow on the Motricity Index) aimed to complete nine, 40-minute sessions on the PST system over three-weeks. Feasibility and acceptability were assessed though semi-structured interview, recording of adverse effects, adherence, enjoyment and perceived exertion. Assessments of impairment, activity and participation, were completed at baseline, immediately post-intervention and 4-weeks post-intervention. Data were analysed using Thematic Analysis of interview transcripts and field-notes, and Wilcoxon Signed Ranks. Side-by-side displays were used to integrate quantitative and qualitative findings. Findings: Integrated findings of safety and ability to use the PST system suggested system feasibility. Themes of the need for personalisation of activities and the necessity of a handsfree system helped explain findings of feasibility. Integrated findings of enjoyment, the acceptability of using the system in different settings and the importance of feedback provided evidence of acceptability. Themes of physical and psychological benefits were supported by improvements in measures of impairment, activity and participation between baseline and immediately post-intervention (p<0.05 for all measures). Conclusion: Personalisation of activities and use of a hands-free system resulted in feasibility and acceptability of the PST system in a group of community dwelling strokesurvivors including those with moderately-severe disability. Therapists should consider using such technologies as an adjunct to traditional rehabilitation, particularly in those with greater stroke severity for whom a lack of suitable alternatives are available.London Regional Innovation Fun

Development and preliminary evaluation of a novel low cost VR-based upper limb stroke rehabilitation platform using Wii technology.

Abstract Purpose: This paper proposes a novel system (using the Nintendo Wii remote) that offers customised, non-immersive, virtual reality-based, upper-limb stroke rehabilitation and reports on promising preliminary findings with stroke survivors. Method: The system novelty lies in the high accuracy of the full kinematic tracking of the upper limb movement in real-time, offering strong personal connection between the stroke survivor and a virtual character when executing therapist prescribed adjustable exercises/games. It allows the therapist to monitor patient performance and to individually calibrate the system in terms of range of movement, speed and duration. Results: The system was tested for acceptability with three stroke survivors with differing levels of disability. Participants reported an overwhelming connection with the system and avatar. A two-week, single case study with a long-term stroke survivor showed positive changes in all four outcome measures employed, with the participant reporting better wrist control and greater functional use. Activities, which were deemed too challenging or too easy were associated with lower scores of enjoyment/motivation, highlighting the need for activities to be individually calibrated. Conclusions: Given the preliminary findings, it would be beneficial to extend the case study in terms of duration and participants and to conduct an acceptability and feasibility study with community dwelling survivors. Implications for Rehabilitation Low-cost, off-the-shelf game sensors, such as the Nintendo Wii remote, are acceptable by stroke survivors as an add-on to upper limb stroke rehabilitation but have to be bespoked to provide high-fidelity and real-time kinematic tracking of the arm movement. Providing therapists with real-time and remote monitoring of the quality of the movement and not just the amount of practice, is imperative and most critical for getting a better understanding of each patient and administering the right amount and type of exercise. The ability to translate therapeutic arm movement into individually calibrated exercises and games, allows accommodation of the wide range of movement difficulties seen after stroke and the ability to adjust these activities (in terms of speed, range of movement and duration) will aid motivation and adherence - key issues in rehabilitation. With increasing pressures on resources and the move to more community-based rehabilitation, the proposed system has the potential for promoting the intensity of practice necessary for recovery in both community and acute settings.The National Health Service (NHS) London Regional Innovation Fund

Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb post Stroke (RHOMBUS II): protocol of a feasibility randomised controlled trial

Introduction Upper limb (UL) rehabilitation is most effective early after stroke, with higher doses leading to improved outcomes. For the stroke survivor, the repetition may be monotonous. For clinicians, providing a clinically meaningful level of input can be challenging. As such, time spent engaged in UL activity among subacute stroke survivors remains inadequate. Opportunities for the stroke survivor to engage with UL rehabilitation in a safe, accessible and engaging way are essential to improving UL outcomes following stroke. The NeuroBall is a non-immersive virtual reality (VR) digital system designed for stroke rehabilitation, specifically for the arm and hand. The aim of the Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb post Stroke study is to determine the safety, feasibility and acceptability of the NeuroBall as a rehabilitation intervention for the UL in subacute stroke. Methods and analysis A feasibility randomised controlled trial (RCT) will compare the NeuroBall plus usual care with usual care only, in supporting UL rehabilitation over 7 weeks. Twenty-four participants in the subacute poststroke phase will be recruited while on the inpatient or early supported discharge (ESD) stroke pathway. Sixteen participants will be randomised to the intervention group and eight to the control group. Outcomes assessed at baseline and 7 weeks include gross level of disability, arm function, spasticity, pain, fatigue and quality of life (QoL). Safety will be assessed by recording adverse events and using pain, spasticity and fatigue scores. A parallel process evaluation will assess feasibility and acceptability of the intervention. Feasibility will also be determined by assessing fidelity to the intervention. Postintervention, semistructured interviews will be used to explore acceptability with 12 participants from the intervention group, four from the usual care group and with up to nine staff involved in delivering the intervention. Ethics and dissemination This trial has ethical approval from Brunel University London’s Research Ethics Committee 25257-NHS-Oct/2020-28121-2 and the Wales Research Ethics Committee 5 Bangor (Health and Care Research Wales) REC ref: 20/WA/0347. The study is sponsored by Brunel University London. Contact: Dr Derek Healy, Chair, University Research Ethics committee ([email protected]). Trial results will be submitted for publication in peer-reviewed journals, presented at national and international conferences and distributed to people with stroke. Trial registration number ISRCTN11440079; Pre-results

ReWiiRe (Research in Wii Rehabilitation):user involvement in the development of a personalised rehabilitation system for arm re-education after stroke

Introduction: Virtual reality gaming systems, such as Nintendo Wii, are increasingly used in rehabilitation to deliver the intensity and repetition of practice necessary to enhance recovery. This abstract reports serviceuser (SU) involvement in the ReWiiRe project (www.rewiire.org.uk); which investigated feasibility and acceptability of rehabilitation using Wii and the development of a personalised stroke treatment (PST), using adapted Wii technology, for arm re-education post-stroke. SUs worked collaboratively with therapists and engineers to develop data-collection tools (aphasia-friendly questionnaire, interview schedules); advised on design and testing of equipment prototypes and design and content of bespoke exercises and games, ensuring that PST was relevant and meaningful. A SU participated in a two week case-study testing PST. Method: Mixed methods: questionnaire, semi-structured interviews and single case-study. Results: 33 questionnaires and 10 interviews were completed. 87.9% (29/33) questionnaire respondents felt Wii helped with rehabilitation. 57.6% (19/33) reported difficulty using equipment. 33.3% (5/15) of SUs reported difficulties using the hand-held remote controls. Therapists believed use of standard Wii was limited due to the high level of dexterity, movement and coordination necessary to operate the system. A case-study using PST demonstrated a high level of user-acceptability and positive changes on outcome measures. Conclusion: Use of standard Wii in arm rehabilitation post-stroke is limited. Issues identified from this study, together with input from SUs have been used to iteratively inform the design and development of PST using adapted Wii technology for arm rehabilitation. Proof of concept was confirmed through a case-study. Further study using the PST is planned

Rehabilitation via HOMe-Based gaming exercise for the Upper limb post Stroke (RHOMBUS): a qualitative analysis of participants’ experience

Objective To report participants’ experiences of trial processes and use of the Neurofenix platform for home-based rehabilitation following stroke. The platform, consisting of the NeuroBall device and Neurofenix app, is a non-immersive virtual reality tool to facilitate upper limb rehabilitation following stroke. The platform has recently been evaluated and demonstrated to be safe and effective through a non-randomised feasibility trial (RHOMBUS).Design Qualitative approach using semistructured interviews. Interviews were audio recorded, transcribed verbatim and analysed using the framework method.Setting Participants’ homes, South-East England.Participants Purposeful sample of 18 adults (≥18 years), minimum 12 weeks following stroke, not receiving upper limb rehabilitation prior to the RHOMBUS trial, scoring 9–25 on the Motricity Index (elbow and shoulder), with sufficient cognitive and communicative abilities to participate.Results Five themes were developed which explored both trial processes and experiences of using the platform. Factors that influenced participant’s decision to take part in the trial, their perceptions of support provided during the trial and communication with the research team were found to be important contextual factors effecting participants’ overall experience. Specific themes around usability and comfort of the NeuroBall device, factors motivating persistence and perceived effectiveness of the intervention were highlighted as being central to the usability and acceptability of the platform.Conclusion This study demonstrated the overall acceptability of the platform and identified areas for enhancement which have since been implemented by Neurofenix. The findings add to the developing literature on the interface between virtual reality systems and user experience.Trial registration number ISRCTN60291412

Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb post Stroke (RHOMBUS II): protocol of a feasibility randomised controlled trial

The Stroke Association and MedCity grant number SA MC 21\10001

Safety, feasibility, acceptability and preliminary effects of the Neurofenix platform for Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke (RHOMBUS): results of a feasibility intervention study

Objectives: To investigate the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper limb (UL). Design: A non-randomised intervention design with a parallel process evaluation. Setting: Participants' homes, South-East England. Participants: Thirty adults (≥18 years), minimum 12-week poststroke, not receiving UL rehabilitation, scoring 9-25 on the Motricity Index (elbow and shoulder), with sufficient cognitive and communicative abilities to participate. Interventions: Participants were trained to use the platform, followed by 1 week of graded game-play exposure and 6-week training, aiming for a minimum 45 min, 5 days/week. Outcomes: Safety was determined by assessing pain and poststroke fatigue at 8 and 12 weeks, and adverse events (AEs). Impairment, activity and participation outcomes were measured. Intervention feasibility was determined by the amount of specialist training and support required to complete the intervention, time and days spent training, and number of UL movements performed. Acceptability was assessed by a satisfaction questionnaire and semistructured interviews. Results: Participants (14 women; mean (SD) age 60.0 (11.3) years) were a median of 4.9 years poststroke (minimum-maximum: 1-28 years). Twenty-seven participants completed the intervention. The odds of having shoulder pain were lower at 8 weeks (OR 0.45, 95% CI 0.24 to 0.83, p=0.010) and 12 weeks (OR 0.46, 95% CI 0.25 to 0.86, p=0.014) compared with baseline. Fugl-Meyer upper extremity, Motor Activity Log and passive range of movement improved. No other gains were recorded. Poststroke fatigue did not change. Thirty mild and short-term AEs and one serious (unrelated) AE were reported by 19 participants. Participants trained with the platform for a median of 17.4 hours over 7 weeks (minimum-maximum: 0.3-46.9 hours), equating to a median of 149 min per week. The median satisfaction score was 36 out of 40. Conclusion: The Neurofenix platform is a safe, feasible and well accepted way to support UL training for people at least three months poststroke.</p

Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb post Stroke (RHOMBUS II): protocol of a feasibility randomised controlled trial

Introduction: Upper limb (UL) rehabilitation is most effective early after stroke, with higher doses leading to improved outcomes. For the stroke survivor, the repetition may be monotonous. For clinicians, providing a clinically meaningful level of input can be challenging. As such, time spent engaged in UL activity among subacute stroke survivors remains inadequate. Opportunities for the stroke survivor to engage with UL rehabilitation in a safe, accessible and engaging way are essential to improving UL outcomes following stroke. The NeuroBall is a non-immersive virtual reality (VR) digital system designed for stroke rehabilitation, specifically for the arm and hand. The aim of the Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb post Stroke study is to determine the safety, feasibility and acceptability of the NeuroBall as a rehabilitation intervention for the UL in subacute stroke. Methods and analysis: A feasibility randomised controlled trial (RCT) will compare the NeuroBall plus usual care with usual care only, in supporting UL rehabilitation over 7 weeks. Twenty-four participants in the subacute poststroke phase will be recruited while on the inpatient or early supported discharge (ESD) stroke pathway. Sixteen participants will be randomised to the intervention group and eight to the control group. Outcomes assessed at baseline and 7 weeks include gross level of disability, arm function, spasticity, pain, fatigue and quality of life (QoL). Safety will be assessed by recording adverse events and using pain, spasticity and fatigue scores. A parallel process evaluation will assess feasibility and acceptability of the intervention. Feasibility will also be determined by assessing fidelity to the intervention. Postintervention, semistructured interviews will be used to explore acceptability with 12 participants from the intervention group, four from the usual care group and with up to nine staff involved in delivering the intervention. Ethics and dissemination: This trial has ethical approval from Brunel University London's Research Ethics Committee 25257-NHS-Oct/2020-28121-2 and the Wales Research Ethics Committee 5 Bangor (Health and Care Research Wales) REC ref: 20/WA/0347. The study is sponsored by Brunel University London. Contact: Dr Derek Healy, Chair, University Research Ethics committee ([email protected]). Trial results will be submitted for publication in peer-reviewed journals, presented at national and international conferences and distributed to people with stroke. Trial registration number: ISRCTN11440079; Pre-results.</p