Rehabilitation Using a Novel Home Based Digital Therapy Device For The Upper-Limb Post Stroke (RHOMBUS): An Intervention Study

Abstract

<h3>Research Objectives</h3> The RHOMBUS (Rehabilitation via home based gaming exercise for the upper-limb post stroke) study aimed to determine the safety, feasibility and acceptability of a novel digital therapy device, "NeuroBall™" for home-based upper-limb rehabilitation post stroke. <h3>Design</h3> The study was a non-randomized intervention study with a parallel mixed methods process evaluation. The study examined the NeuroBall as an upper limb intervention to promote self-directed exercise with occasional therapist oversight over a seven-week intervention period. <h3>Setting</h3> Stroke survivors were given the NeuroBall device and its associated tablet computer to use independently in their own home in the London area, UK. <h3>Participants</h3> Thirty stroke survivors (women n=14), median age 60, median 4.9 years post-stroke, with mild to severe upper limb impairment (FMA-UE scores between 8 and 63) who were no longer receiving therapy. <h3>Interventions</h3> Participants were trained to use NeuroBall and its associated tablet software at home for 7 weeks by a research physical therapist. <h3>Main Outcome Measures</h3> Therapy compliance was measured objectively by NeuroBall's software, patient satisfaction and functional improvements were measured by postintervention questionnaires and semi-structured interviews. Arm function was assessed by Fugl-Meyer Assessment - upper-limb (FMA-UL) Adverse events were monitored by the investigators. <h3>Results</h3> Participants exercised a median 17.4 hours (15,092 movements) during the 7-week intervention. NeuroBall had high acceptability (median enjoyment 4/5) and satisfaction levels (median QUEST score 36/40). Device-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 incidence of shoulder pain at 8 weeks was lower than that at baseline (OR 0.45, 95%CI 0.24-0.83, p=0.010). <h3>Conclusions</h3> Results suggest that NeuroBall is a safe, feasible, and acceptable intervention for home-based rehabilitation of the upper-limb post stroke; future work is required to determine efficacy in a larger randomized controlled trial. <h3>Author(s) Disclosures</h3> Karen Baker is employed by Neurofenix (UK), the company that designed and manufactures NeuroBall. Neurofenix provided the NeuroBall devices and technical support to the research therapists. Neurofenix had no influence on the design of the study, data collection, analysis and interpretation of the data. The writing of this abstract has the full support of the independent research team who carried out the research independently.