STEPS II
Research type
Research Study
Full title
The Efficacy of Peroneal Nerve Functional Electrical STimulation (FES) for the Reduction of Bradykinesia in Parkinson’s DiSease: An Assessor Blinded Randomised Controlled Trial
IRAS ID
330866
Contact name
Paul Taylor
Contact email
Sponsor organisation
Salisbury NHS Foundation Trust
Duration of Study in the UK
3 years, 6 months, 30 days
Research summary
People with Parkinson’s disease (pwPD) often have difficulty walking and may walk slowly, take small steps, freeze and fall. This can lead to a reduced quality of life (QoL) and greater dependence on others.
Functional Electrical Stimulation (FES) is a technique that applies small electrical impulses from a device through self-adhesive pads placed on the skin to produce movement in under active muscles, which can assist walking. It is routinely used in people who have multiple sclerosis (MS) or who have had a stroke. However, there is insufficient evidence for its use in pwPD. This research aims to determine if FES is beneficial for pwPD and how it works.
Previous small studies, including the STEPS feasibility study, showed that pwPD may walk faster and have reduced symptoms after using FES. Improvement may be seen in walking for days after using FES, an effect called 'carryover'. Participants reported greater confidence and more independence. The feasibility study also showed that the treatment and study procedures were acceptable. We are now undertaking a larger study to formally assess the effect of FES on walking speed and the wider effects of FES in pwPD.
234 pwPD will be recruited from 7 sites. One half will have ‘usual care’ and the other ‘FES + usual care’. FES will be used for 18 weeks then withdrawn for 4 weeks, to see if effect lasts. We will measure changes in walking speed, falls, balance, PD symptoms and QoL. A subgroup of participants and their partners/carers will take part in qualitative interviews so that we can find out about their experiences of using FES.
Participants will have a screening appointment, baseline assessment and four blinded assessments, which will be carried out by a clinician who does not know the group allocation. Participants receiving FES will also have four FES set-up/follow-up sessions.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0193
Date of REC Opinion
22 Sep 2023
REC opinion
Further Information Favourable Opinion