SHAPES: Assessing the impact of a novel therapeutic electrical stimulation device for post-stroke arm spasticity

Generating relevant clinical and economic evidence to assess impact and aid future implementation of novel health technology.

Key Aims:

• Investigate the cost-effectiveness of a novel post-stroke spasticity device therapy.
• Assess the patient experience including of device usability and engagement.
• Inform the most appropriate stroke patient sub-groups and timing of device access in the patient journey

The co-leads of the Pathways to Implementation and Impact (PII) Theme have key leadership roles in the evaluation of, and commercialisation strategy for, a novel non-invasive therapeutic device – ShefStim APS. Intended to treat post-stroke arm spasticity and designed for home-use, the clinical investigational device has been co-developed at Sheffield Teaching Hospitals with patient input. The PII theme is managing the on-going 3-arm randomised control trial which is collecting clinical efficacy, health resource utilisation, and quality-of-life metrics, alongside qualitative patient experience data. The latter aspect is in collaboration with the co-lead of the Methodology Innovation (MI) Theme at Coventry University.

The study is currently being run as a single site study in Sheffield with local patient identification centre sites. Having implemented and reviewed the protocol with participant feedback, progress is underway to extend recruitment across multiple participating sites. This will be supported by an increase in remote visits to further minimise participant travel burden. In parallel, the PII theme has led the protection of Intellectual Property associated with the novel device through three patent applications, and has contributed to research publications.