Summary

Summary

  • The technology described in this briefing is RT300, a functional electrical stimulation (FES) integrated cycling system. It is used to start muscle contraction to stimulate trunk and limb muscles in people with spinal cord injury.

  • The innovative aspect is that the RT300 combines FES with a cycle ergometer, allowing stimulation of muscles in the trunk and arms or legs during a cycling motion as part of rehabilitation or physical activity for people with spinal cord injury. The combined motor and electrical stimulation system adjusts resistance and speed to make sure stimulation is safe for optimal treatment. The system links to a database to store and monitor performance data.

  • The intended place in therapy would be as well as standard rehabilitation care for people with spinal cord injuries. This would start in specialist spinal injuries units but can be given in any setting.

  • The main points from the evidence summarised in this briefing are from 6 studies (3 randomised trials and 3 observational studies), including a total of 103 patients (43 adults and 60 children) in the US and Canada. Limited evidence shows that using RT300 may be associated with an improvement in quality of life and an increase in muscle volume compared with passive cycling systems or pre‑treatment baseline.

  • Key uncertainties around the evidence or technology are that the study results may not be generalisable to the NHS. The studies were small and the comparative studies used a passive cycling system from the same manufacturer.

  • The cost of RT300 ranges from £14,995 to £21,995 per unit with 6‑channel stimulations (exclusive of VAT) plus an annual service charge of £495. An extra 6‑channel stimulation unit costs £6,995. The resource impact is unclear because of a lack of evidence and uncertainty in the standard care pathway and which people may benefit.