STEPS
Research type
Research Study
Full title
The Effectiveness of Peroneal Nerve Functional Electrical STimulation (FES) for the Reduction of Bradykinesia in Parkinson’s Disease: A Pragmatic Feasibility Study for a Single Blinded Randomised Control Trial (STEPS)
IRAS ID
192222
Contact name
Paul Taylor
Contact email
Sponsor organisation
Salisbury NHS Foundation Trust
ISRCTN Number
ISRCTN17609599
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
People with Parkinson’s disease (PD) often have difficulty in walking, which causes them to walk slowly and fall, leading to a reduced quality of life. Functional Electrical Stimulation (FES) can be used to produce useful movements in under active muscles, by applying small electrical impulses to their nerves, using a small battery powered device worn on the leg.\n \nIn previous small studies, we have shown that patients are able to walk faster and have reduced PD symptoms after using FES. We want to carry out a larger study to investigate whether FES would be beneficial to patients in the longer term when compared to routine care and whether it would be value for money for the NHS. Before setting up a larger study, we need to run a smaller study to ensure we design the full study properly. We especially want to know how many people will complete the study and the reasons why some people don’t. \n\nSixty-eight people who have PD will be randomly allocated to have either FES with routine care or routine care alone. Over 22 weeks we will measure the changes in walking speed, falls, quality of life and PD symptoms. We also want to determine if we are asking the right questions, and if the study methods are acceptable. We will interview participants to find out what they think about the study and whether there are things we should improve.\n\nA Patient Advisory Group has been formed from participants of the earlier studies. They have contributed to the design of this research and will advise on all aspects of the study.\nOur results will be used to plan the larger full study. They will be made available to other people doing research into Parkinson’s Disease and summarised on the Parkinson’s Society website.\n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0041
Date of REC Opinion
3 Mar 2016
REC opinion
Further Information Favourable Opinion