Chief Investigator: Dr Paul Taylor
Recruiting Sites: Salisbury, Birmingham, Swansea, Leads and North Cumbria (Derby and Betsi Cadwalladr opening soon)
Timeframe: The study opened to recruitment in January 2024 and the scheduled study end date is the 30th August 2025.
UK Recruitment Target: 234
Link to further information: STEPS II Study Website
The Efficacy of Peroneal Nerve Functional Electrical STimulation (FES) for the Reduction of Bradykinesia in Parkinson’s DiSease: An Assessor Blinded Randomised Controlled Trial
STEPS II is a National Institute for Health and Care Research funded study for people with Parkinson’s Disease (PD), sponsored by Salisbury NHS Foundation Trust and managed by the University of Plymouth's Peninsula Clinical Trials Unit. Paul Taylor (Consultant Clinical Scientist at Salisbury District Hospital) is the Chief Investigator and will be leading the research.
Study Goal:
People with PD often have difficulty walking. This can cause them to walk slowly, take small steps and increases the risk of falls. These challenges can lead to a reduced quality of life and greater dependence on others. This is a study testing a device that aims to improve walking in people with PD. The device is attached to the leg and produces small electrical impulses that improve movement, using a safe technique called functional electrical stimulation (FES).
What's involved:
Functional Electrical Stimulation (FES) is a non-invasive procedure that involves wearing a battery-operated device on the leg that applies small electrical impulses to the nerves, to help encourage movement in muscles that are not working properly. It is commonly used by people who have had a stroke or have multiple sclerosis to help improve their walking, as FES can make walking easier, safer, and faster. The teams would would like to find out if FES could produce similar benefits in People with Parkinson's. Participants will be assigned to one of two groups: those receiving their usual care, and those using FES in addition to their usual care. Those using FES, will be asked to use the device daily for 18 weeks. Both groups will have additional appointments, some face-to-face and some telephone, with the study team. To find out more about what is involved, you can access the Participant Information Sheets here.
Study Status:
We previously carried out a small (feasibility) study, which showed that FES can help patients walk faster and reduce some symptoms of PD. STEPS II is currently open to recruitment at 6 sites across the UK (Salisbury, Leeds, Sheffield, Birmingham, Swansea, Prestwick) with another site hopefully opening soon.
To discuss becoming a participating site, contact: STEPS II Trial Manager steps2.penctu@plymouth.ac.uk or our coordinator Emma Fargher md4efa@sheffield.ac.uk
If you would like to take part in this study, you can visit the study webpage to self-refer at your chosen site.
If you have any questions, please contact the trial manager steps2.penctu@plymouth.ac.uk or our coordinator Emma Fargher md4efa@sheffield.ac.uk