A new therapy for post-stroke arm spasticity: Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) - a co-designed system improvement followed by a powered multi-arm randomised control trial.
Around 35% of stroke survivors develop long-term disabling arm spasticity, and a new electrical stimulation device called SHAPES aims to give them a way to treat it at home without needing a therapist. Current treatments for post-stroke spasticity—such as physiotherapy or standard TENS machines—often require clinic visits or provide only temporary relief. SHAPES delivers a location-varying sensory barrage stimulation that previous pilot studies suggested could reduce spasticity and improve arm function more effectively than existing options. The research team will first refine the device to make it user-friendly and suitable for a blinded trial, then recruit 204 participants across hospital and home settings. Each participant will receive either SHAPES, standard TENS, or usual physiotherapy for six weeks, with follow-up at three and six months to check whether any benefits persist. If the trial shows SHAPES works better than current care, it could become a self-managed, at-home therapy that reduces the burden on NHS rehabilitation services and improves quality of life for stroke survivors. The NHS England Long Term Plan has prioritised expanding at-home post-stroke rehabilitation, and a proven device would directly support that goal. If the trial finds no benefit, the results will still guide future research and prevent ineffective treatments from being adopted.
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1. RESEARCH QUESTIONS: Primary: Does the Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) location-varying sensory- barrage stimulation (SBS), have clinical efficacy to improve arm-function by reducing post-stroke spasticity (PSS)? Is SHAPES superior to sensory Transcutaneous-Electrical-Nerve-Stimulation (TENS) and usual care (physiotherapy)? Secondary: Does SHAPES therapy confer persistent PSS improvement at 3 and 6 months post-therapy? 2. BACKGROUND The NHS England Long Term Plan has prioritised increased availability and quality of at-home post-stroke rehabilitation (4). Approximately 35% of stroke survivors develop long-term disabling arm-PSS (1). Previous ShefStim-SBS device pilot and feasibility studies delivering SHAPES showed that SHAPES had promise as a self-managed PSS-therapy. 3. AIMS AND OBJECTIVES Aims: Development of a robust user-friendly ShefStim-SBS system to enable a blinded-design Randomised Control Trial (RCT) where participants are unaware of the stimulation type. Recruit to and undertake an RCT comparing SHAPES with TENS and usual care Objectives: Successful completion of fully-powered RCT to time and target, gaining evidence for SHAPES clinical efficacy as PSS-therapy. 4. METHODS A pragmatic, powered RCT recruiting participants with post-stroke arm motor-deficit from 2 weeks post-stroke for 6 weeks of therapy will span the stroke rehabilitation pathway to inform future adoption. The project exit point would be successful completion of RCT with good adherence by 204 participants (68 per treatment-type) across hospital and home settings. 5. TIMELINES FOR DELIVERY 39 month project: first 12 months focussing on developing ShefStim-SBS system RCT will start at month 13: spanning 21 months. Final 6 months: measuring therapy carry-over effects at 3&6 months, dissemination. 6. ANTICIPATED IMPACT AND DISSEMINATION Key measures of success: Completion of RCT to time and target Improvements in patient-reported, clinical-outcome measures for spasticity, arm-function and quality-of-life compared to TENS and usual care Future Impact Peer-reviewed publications to support or refute SHAPES adoption A new disruptive technology to support self-managed PSS-therapy at home
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