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.

To investigate the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper limb (UL). A non-randomised intervention design with a parallel process evaluation. Participants' homes, South-East England. 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. 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. 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. 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. The Neurofenix platform is a safe, feasible and well accepted way to support UL training for people at least three months poststroke. ISRCTN60291412.

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© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: GS-B and DAA are employed by Neurofenix (United Kingdom), a digital therapeutics company developing a therapy platform and sensor-based devices to augment rehabilitation. Neurofenix provided the Neurofenix 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. KB and DJMS were employed by Brunel University London during the period of the study, and are now Neurofenix employees.