Cherry Kilbride(1), Alex Nowicky(1), Alyson Warland(1),, Thomas Butcher(1), Meriel Norris(1), Guillem Buxarrais Singla(3), Daniel Scott(1,3), Karen Baker(1,3), Dimitris Athanasiou(3), Nana Anoyke(1), Elizabeth Cassidy(4), Jennifer Ryan(1,2)
(1)Department of Health Sciences, Brunel University London, UK.
(2) Department of Epidemiology and Public Health Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
(3)Neurofenix, London, UK.
(4)Independent academic, London, UK.
Introduction
Effective interventions to promote upper-limb recovery post-stroke are characterised by intensive and repetitive movements. It is reported that stroke survivors move their arm an average of 32 times per therapy session; this is insufficient to drive neuroplastic change. The Neurofenix platform is a novel virtual reality gaming device designed to enable and encourage stroke survivors to independently exercise their upper-limb at home. The RHOMBUS study aimed to determine the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper-limb poststroke.
Methods
This is an interventional study with a parallel process evaluation. Community dwelling stroke survivors with mild to severe arm impairment (9-25 Motricity Index for shoulder and elbow) were trained to use the Neurofenix platform at home for 7-weeks, aiming for a minimum weekly dose of 225 minutes. Clinical and technical support was available if required. All participants were assessed at baseline, weeks 8 and 12 for safety (e.g. pain, fatigue, adverse events); acceptability (e.g. questionnaire, interviews) and feasibility (e.g. recruitment and retention, technical and clinical calls, frequency and time of use, repetitions of movements. Fidelity to the intervention was measured objectively by the Neurofenix platform. Secondary measures included the Action Research Arm Test, Fugl-Meyer upper-limb, Subjective Index of Physical and Social Outcome and EQ-5D-L. Data were analysed with descriptive and inferential statistics to examine change between baseline and follow-up assessments. A generalised estimating equation with a logit link, exchangeable working matrix and robust standard errors was used to examine if the odds of shoulder pain changed over time.
Results and discussion
Thirty participants (women n=14), median age 60, median 4.9 years post-stroke, FMA-UE scores 8 to 63 were recruited. Participants exercised a median 17.4 hours (15,092 movements) during the 7-week intervention. The Neurofenix platform had high acceptability (median enjoyment 4/5) and satisfaction levels (median QUEST score 36/40). Related adverse events were mild and short term (e.g. muscle soreness). Shoulder external rotation improved by 7.1° (95%CI 2.4-11.8, p=.049) and the odds of shoulder pain at 8 weeks was lower than that at baseline (OR 0.45, 95%CI 0.24-0.83, p=0.010).
Conclusions
Results suggest the Neurofenix platform is a safe, feasible, and acceptable intervention for independent home-based rehabilitation of the upper-limb post stroke in stroke survivors post 6-months. Future work is required to determine the feasibility of the device in the acute stroke care pathway before undertaking a definitive randomised controlled trial to determine efficacy