SHAPES: A new therapy for post-stroke arm spasticity. Version 1.
Research type
Research Study
Full 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.
IRAS ID
309757
Contact name
KP Sivaraman Nair
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN26060261
Duration of Study in the UK
2 years, 3 months, 4 days
Research summary
1. What is the purpose of the study?
Following a stroke people often experience muscle stiffness (spasticity) in their arm. This stiffness can restrict free arm movement. The Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) and Transcutaneous Electrical Nerve Stimulation (TENS) are two different techniques to stimulate sensory nerves using electrical pulses. These techniques may be able to reduce muscle spasticity. The purpose of this study is to compare the effects on spasticity at the elbow of adding either SHAPES or TENS therapy to usual care with usual care only.
2. What is the device that is being tested?
We have developed a small, battery-powered lightweight stimulator (ShefStim APS) that is worn on the arm. We have used a similar system previously in two small studies to see if it would benefit people who have muscle stiffness following a stroke. The results showed promise. We need to do a larger study with more people to be sure that it is beneficial. ShefStim APS allows us to stimulate many different areas of the arm at the same time, which may be more effective than the single-site stimulation previously used. We can also vary the timing and strength of each stimulus pulse in a random way to maximise its effect by preventing the body getting used to it. We have named this method Sheffield Adaptive Patterned Electrical Stimulation (SHAPES). We want to find out whether this new technique will be better than conventional TENS stimulation in reducing spasticity at the elbow.REC name
London - Queen Square Research Ethics Committee
REC reference
22/LO/0203
Date of REC Opinion
11 May 2022
REC opinion
Further Information Favourable Opinion