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

<p dir="ltr"><b>Objective:</b><b> </b>To investigate the safety, feasibility and acceptability of the Neurofenix platform for upper-limb rehabilitation in acute and subacute stroke. <p dir="ltr"><b>Design:</b><b> </b>A feasibility randomised controlled trial with a parallel process evaluation. <p dir="ltr"><b>Setting:</b><b> </b>Acute Stroke Unit and participants' homes (London, UK). <p dir="ltr"><b>Participants:</b><b> </b>24 adults (>18 years), acute and subacute poststroke, new unilateral weakness, scoring 9-25 on the Motricity Index (elbow and shoulder), with sufficient cognitive and communicative abilities to participate. <p dir="ltr"><b>Interventions:</b><b> </b>Participants randomised to the intervention or control group on a 2:1 ratio. The intervention group (n=16) received usual care plus the Neurofenix platform for 7 weeks. The control group (n=8) received usual care only. <p dir="ltr"><b>Outcomes:</b><b> </b>Safety was assessed through adverse events (AEs), pain, spasticity and fatigue. Feasibility was assessed through training and support requirements and intervention fidelity. Acceptability was assessed through a satisfaction questionnaire. Impairment, activity and participation outcomes were also collected at baseline and 7 weeks to assess their suitability for use in a definitive trial. <p dir="ltr"><b>Randomisation:</b><b> </b>Computer-generated, allocation sequence concealed by opaque, sealed envelopes. <p dir="ltr"><b>Blinding:</b><b> </b>Participants and assessors were not blinded; statistician blinded for data processing and analysis. <p dir="ltr"><b>Results:</b><b> </b>192 stroke survivors were screened for eligibility, and 24 were recruited and randomised. Intervention group: n=16, mean age 66.5 years; median 9.5 days post stroke. <p dir="ltr"><b>Control group:</b><b> </b>n=8, mean age 64.6 years; median 17.5 days post stroke. Three participants withdrew before the 7-week assessment, n=21 included in the analysis (intervention group n=15; control group n=6). No significant group differences in fatigue, spasticity, pain scores or total number of AEs. The median (IQR) time to train participants was 98 (64) min over 1-3 sessions. Participants trained with the platform for a median (range) of 11 (1-58) hours, equating to 94 min extra per week. The mean satisfaction score was 34.9 out of 40. <p dir="ltr"><b>Conclusion:</b><b> </b>The Neurofenix platform is safe, feasible and well accepted as an adjunct to usual care in acute and subacute stroke rehabilitation. There was a wide range of engagement with the platform in a cohort of stroke survivors which was varied in age and level of impairment. Recruitment, training and support were manageable and completion of data was good, indicating that a future randomised controlled trial would be feasible. <p dir="ltr"><b>Trial registration number:</b><b> </b>ISRCTN11440079.