Title: 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.
Funder: Department of Health and Social Care

Abstract: 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

Lay abstract: 1. Aim We wish to see if a novel therapy (SHAPES) for relaxing tight arm muscles after stroke is better than two other treatments. Results from a small trial (16 people) showed promise. We need a bigger trial (204 people) to be confident of SHAPES benefits. 2. Background 85,000 people per year in the UK have a stroke, and numbers will double in 20 years. Strokes damage the brain, often making arm muscles hard to control. They become weak and then stay tight when they should relax. This over-tightness can become painful and disabling because muscles shorten and the arm cannot be moved freely. Treatment options are limited. Available medicines have significant side-effects and can be expensive. Physiotherapy can help early on when in hospital but many patients are not offered it once they go home. 3. Design and Methods We have developed a versatile new device (ShefStim-SBS) that sends tiny electrical pulses across 64 individual locations (SHAPES). It produces moving patterns of sensation - like being stroked. Other devices (TENS) work similarly but only at 2 non&ndash;moving locations &ndash; like tapping . There are two project strands: Year1: Development of the ShefStim-SBS system, with patient and public support, to be: Cheaper to make Easier to wear and use at home Years2&3: Completing the trial We will modify ShefStim-SBS to deliver either type of treatment (SHAPES or TENS) so that trial participants won t know which type they are receiving. We need 68 people per group to complete the trial to be confident of the results. Stroke survivors with arm weakness 2 weeks after stroke will get one of three types of treatment for 6 weeks: SHAPES TENS Standard physiotherapy Volunteers will be assigned their treatment at random. Participants will self-assess their arm daily, plus testing by physiotherapists done at: Weeks 0, 6, 18, 30 and compared across groups. We expect SHAPES to prompt better re-learning of muscle control than with TENS because the brain is more alert to moving sensations. The small box will be worn within an elasticated sleeve, fitted by the patient or their carer, in hospital or at home. We will work with economic experts to see if the new treatment would offer good value for money. 4. Patient/Public involvement (PPI) Participants in our small-scale trial were positive about SHAPES, advised on the bigger trial and are keen to be involved in the project. They, and other stroke survivors, will be invited to offer their views on the design throughout the project. 5. Dissemination We are optimistic that the study results will prompt commercial interest. Once we have legal protection for the ideas we will publicise the results across a range of journals and news media.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: STROKE