Rehabilitation Using Virtual Gaming for Hospital and Home-based Upper Limb Training in Acute and Subacute Stroke (RHOMBUS II): Results of a Feasibility Randomised Controlled Trial

Research Objectives: To investigate the safety, feasibility and acceptability of the Neurofenix platform for upper-limb rehabilitation in acute and subacute stroke.

Design: A feasibility randomised controlled trial with a parallel process evaluation.

Setting: Acute Stroke Unit and participants’ homes.

Participants: Twenty- four 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.

Interventions: Participants randomised to the intervention or control group on a 2:1 ratio. Intervention group (N=16) received usual care plus the Neurofenix platform for 7-weeks. Control group (N=8) received usual care only.

Main Outcome Measures: Safety assessed through adverse events (AEs), pain, spasticity and fatigue. Feasibility assessed through training and support requirements and acceptability through intervention fidelity and 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.

Results: 192 stroke survivors screened for eligibility, 24 recruited and randomised. Intervention group (n=16) (mean age 66.5 years; median 9.5 days post-stroke). Control group (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 analysis (intervention group n=15; control group n=6). No significant group differences in fatigue, spasticity, pain scores or total number of AEs. Median (IQR) time to train participants was 98 (64) minutes over one to three sessions. Participants trained with the platform for a median (range) of 11 (1-58) hours, equating to 94 minutes extra per week. The mean satisfaction score was 34.9 out of 40.

Conclusions: Neurofenix platform is safe, feasible and well-accepted as an adjunct to usual care in acute and subacute stroke rehabilitation. Recruitment, training and support were manageable and completion of data was good, indicating that a future randomised controlled trial would be feasible.

Author(s) Disclosures: DAA, KB and GS-B are employed by Neurofenix (UK) and USA, a digital therapeutics company developing a therapy platform and sensor-based devices to augment rehabilitation. Neurofenix provided the VR platforms 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 or manuscript preparation.