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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Avril McCarthy
+44 (0)114 2711758
avril.mccarthy@nhs.net


Dr KP Sivaraman Nair
+44 (0)114 2712769
siva.nair@nhs.net


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - A randomised trial of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) as a new therapy for post-stroke arm spasticity
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A randomised trial of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) as a new therapy for post-stroke arm spasticity

Recruiting

Open to: All Genders

Age: Mixed

Sheffield Barnsley Doncaster Rotherham Barnsley

Medical Conditions

Post-stroke arm spasticity

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Following a stroke people often experience muscle stiffness (spasticity) in their arms. The study team have developed a small device that is worn on the arm which stimulates sensory nerves using gentle electrical pulses. It can give two forms of stimulation: Transcutaneous Electrical Nerve Stimulation (TENS) and Sheffield Adaptive Patterned Electrical Stimulation (SHAPES). These techniques may be able to reduce muscle spasticity. The study team want to understand if the addition of either of the two forms of electrical stimulation to usual care adds any extra benefits. The purpose of this study is to compare the effect of SHAPES and TENS on spasticity at the elbow alongside the usual treatment.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

22 May 2023 31 Jul 2025

Publications

2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36001089/ Overview of the usability engineering process (added 28/06/2023)2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39522015/ (added 20/11/2024)

Those agreeing to participate in this trial will receive one of three types of treatment for six weeks. Participants are allocated to groups randomly.
1. Group-1 will receive the SHAPES stimulation with the usual care
2. Group-2 will receive TENS stimulation with the usual care
3. Group-3 will receive usual care without electrical stimulation

Those in all groups will be asked to do a simple rating of their level of muscle stiffness daily. Before and 6 weeks after the study treatment, all study participants will have their arm movement assessed by a therapist and be asked to complete some questionnaires about how their arm spasticity affects them. After the 6 weeks of treatment, participants will be invited for follow-up assessments with a therapist:
1. At 6 weeks
2. At 12 weeks
3. Then at 24 weeks


Adults aged 18-100 years old who have had a stroke between 2 and 16 weeks ago and who have post-stroke arm spasticity. Only those with a certain level of arm weakness and muscle stiffness would be eligible to participate. The study is single-site and sponsored by Sheffield Teaching Hospitals. Participants will be identified from eligible stroke centres within the South Yorkshire region.

You can take part if:



You may not be able to take part if:


The following criteria will be reviewed and a final judgement made based on clinical experience by medically qualified study team investigators (Neurologists at Consultant or Registrar level). Eligibility will be confirmed before randomization. The threshold for meeting criteria 1, 2, 3, 4, and 7 will be the degree to which, in the opinion of the investigator, it could significantly interfere with participation in the study:1. Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with elbow movement 2. Pre-existing severe systemic disorders like cardiovascular disease, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, psychiatric illness including severe alcohol or drug abuse and depression3. Inability to perform the baseline assessments4. Severe tactile hypersensitivity5. Participation in other spasticity-related studies 6. Within 12 weeks of receiving Botulinum toxin injections7. Uncontrolled epilepsy8. All forms of implanted electrical/electronic device9. Pregnancy10. Inability to provide informed consent11. Pre-existing upper limb spasticity12. Previous acute contact dermatitis and/or known allergy to acrylates


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Hallamshire Hospital
    Glossop Road
    Sheffield
    S10 2JF
  • Barnsley Hospital NHS Foundation Trust
    Gawber Road
    Barnsley
    S75 2EP
  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
    Doncaster Royal Infirmary Armthorpe Road
    Doncaster
    DN2 5LT
  • The Rotherham NHS Foundation Trust
    Moorgate Road
    Rotherham
    S60 2UD
  • South West Yorkshire Partnership NHS Foundation Trust
    Kendray Hospital Lodge Doncaster Road
    Barnsley
    S70 3RD

You are not expected to gain any benefits from taking part in this research. The information arising might help improve the treatment of people with spasticity due to stroke. The treatment may result in a temporary reduction in the spasticity in your arm. The study team will follow up at 6, 12 and 24 weeks to see if there might be reductions in your arm spasticity that continue after you finish the study.
The sensory stimulation used in this study is not associated with any known side effects. It is not anticipated that any permanent or serious adverse effects. Possible side effects include a feeling of tightness during the therapy, skin redness, discolouration, irritation and rarely pain. These side effects are transient, lasting only for few minutes. However, as there is only limited experience with SHAPES, there might be unknown side effects.

Dr Avril McCarthy
+44 (0)114 2711758
avril.mccarthy@nhs.net


Dr KP Sivaraman Nair
+44 (0)114 2712769
siva.nair@nhs.net



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN26060261

Or CPMS 52321

Last updated 08 January 2025

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