Trial ID: ISRCTN13120555
Other - Phase Unknown - No longer available
Background and study aims People with Parkinson’s disease (pwPD) often have difficulty walking. This causes them to move and walk slowly (bradykinesia), take small steps, freeze (involuntary stopping while walking) and they are more likely to fall. These challenges lead to a reduced quality of life and greater dependence on others. Functional Electrical Stimulation (FES) is a safe technique that applies small electrical impulses from a compact, battery-powered device through self-adhesive pads placed on the skin over the nerves that supply muscles. FES can be used to produce useful movements in underactive muscles. For example, the muscles that lift the foot can be stimulated to assist in walking. This treatment is routinely used to assist walking in people who have multiple sclerosis (MS) or have had a stroke and is a recommended treatment by NICE (National Institute for Health and Care Excellence). However, there is insufficient evidence for its use in pwPD. This research aims to determine if FES is beneficial for pwPD and if so, how it might be working in PD. In previous small studies, the study team have shown that pwPD may be able to walk faster and have reduced PD symptoms after using FES, including fewer falls and freezing episodes. Unlike with MS and stroke, pwPD experienced an improvement in walking for days, or even longer, after using FES, an effect called 'carryover' - not found in MS and stroke. Following that earlier work, a feasibility study was undertaken with 64 participants to inform the design of this larger study. The feasibility study results also suggested that FES can improve walking. Several participants reported greater confidence when walking, enabling more independence and a return to activities such as using public transport and visiting the shops. This study also showed that the FES treatment, its procedures and measurements were acceptable to pwPD. We now need to undertake a larger study to formally assess the effect of FES on walking speed. The study will also collect data to assess the wider effects of FES in pwPD to inform the need for and design of future research. Who can participate? pwPD aged 18 years and above What does the study involve? Half of the recruited participants will be randomly allocated to have FES with usual care and half will have usual care alone. FES will be used for 18 weeks and then withdrawn for 4 weeks to determine the effect of FES and also see if any effect lasts after stopping its use. The study will measure changes in walking speed, falls, balance, PD symptoms and quality of life. A subgroup of 30 participants who receive FES will be asked to take part in interviews so that we can find out about their experiences of using FES. We will also interview partners and carers to find out their experiences. Throughout the development of our research, we have worked with people who have PD to refine our research ideas. A Patient Advisory Group has been formed including participants from the feasibility study. This group has contributed to the design of this research and will advise on all aspects of the study. A summary of the study results will be given to the participants and offered to Parkinson’s UK for their website and other PD websites. The results will be shared with the research and clinical communities through scientific publications and conference presentations. We will provide the results to NICE to enable updating of their guidelines and to clinicians who already use FES and physiotherapists working with pwPD. What are the possible benefits and risks of participating? Although it has not yet been proven, information from the previous small study showed that FES can improve walking speed, reduce falls, and reduce the overall impact of PD. If good evidence for these effects is produced in this study, it may lead to a new treatment being available within the NHS. There are no known serious risks from using FES, but there are some minor ones: 1. The stimulation feels a bit like pins and needles. Most people become used to it quickly, but it is possible that the participant may find the sensation too uncomfortable and may decide not to use the device. Similarly, turning the stimulation up too high may be uncomfortable, but not dangerous. During your FES set-up visit, the clinician will determine which setting is the best for them. 2. In some cases, skin irritation from the sticky patches may occur. If this happens, the participant will be asked to contact their FES clinician. They will provide advice on how to solve the problem. 3. Some people who have epilepsy can have an increase in symptoms in response to electrical stimulation. The ODFS Pace, the FES device used in this study, has been extensively used by people who have other neurological conditions such as Multiple Sclerosis and stroke. No serious adverse effects from using the device have been recorded. Where is the study run from? Salisbury District Hospital (UK) When is the study starting and how long is it expected to run for? March 2023 to October 2026 Who is funding the study? National Institute for Health and Care Research (NIHR), Efficacy and Mechanism Evaluation Programme (EME) (UK) Who is the main contact? Abbey Tufft, abbey.tufft@plymouth.ac.uk (UK)
Salisbury NHS Foundation Trust
Source: https://www.isrctn.com/