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.

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 (Derek.healy@brunel.ac.uk). 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.

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. TRIAL REGISTRATION NUMBER: ISRCTN60291412.

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

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.