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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:

Prof Paul Taylor
+44 (0)1722 429 119
p.taylor@salisburyfes.com


Miss Abbey Tufft
+44 (0)7794132994
abbey.tufft@plymouth.ac.uk


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 - Assessment of electrical stimulation to improve movement for people who have Parkinson’s disease
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Assessment of electrical stimulation to improve movement for people who have Parkinson’s disease

Recruiting

Open to: All Genders

Age: Senior

Salisbury Birmingham Leeds Port Talbot

Medical Conditions

Parkinson's disease

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.


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.

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:

01 Oct 2023 31 Aug 2025

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.


pwPD aged 18 years and above

You can take part if:



You may not be able to take part if:


Current participant exclusion criteria as of 13/10/2023:1. Receiving, or scheduled to start, deep brain stimulation, within the next 6 months2. Receiving or scheduled to start apomorphine or duodopa within the next 6 months (those who are currently taking duodopa and apomorphine are eligible)3. Pyramidal and/or extrapyramidal systems injuries4. Untreated or refractory epilepsy with seizures in the last 3 months5. Pregnancy or planned pregnancy6. Cardiac pacemaker, or other active medical implanted devices7. Denervation of the common peroneal nerve, or other neurological condition known to cause dropped foot8. Severe osteoarticular pathology that involves the calf bones, knee and tibiotarsal joints, or other conditions that significantly affect walking9. Malignancy or dermatological conditions in the leg that would be stimulated10. Major cognitive impairment; dementia under treatment for an unresolved deep vein thrombosis in the leg that would be stimulated11. Participating in another interventional clinical trial (observational studies are permitted)



Previous participant exclusion criteria:1. Able to walk 10m in less than 8.0s (walking speed greater than 1.25ms-1)2. On, or scheduled to start, PD treatment other than standard drug therapy (deep brain stimulation, duodopa, apomorphine)3. Atypical or secondary parkinsonism, or parkinsonism related to other neurodegenerative diseases4. Pyramidal and/or extrapyramidal systems injuries5. Untreated or refractory epilepsy with seizures in the last 3 months6. Pregnancy or planned pregnancy7. Cardiac pacemaker, or other active medical implanted devices8. Denervation of the common peroneal nerve, or other neurological condition known to cause dropped foot9. Severe osteoarticular pathology that involves the calf bones, knee and tibiotarsal joints, or other conditions that significantly affect walking10. Malignancy or dermatological conditions in the leg that would be stimulated


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

  • Salisbury District Hospital
    Salisbury District Hospital Odstock Road
    Salisbury
    SP2 8BJ
  • University Hospitals Birmingham NHS Foundation Trust
    Queen Elizabeth Hospital Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Leeds Teaching Hospitals NHS Trust
    St. James's University Hospital Beckett Street
    Leeds
    LS9 7TF
  • Swansea Bay University Local Health Board
    One Talbot Gateway, Seaway Drive Seaway Parade Industrial Estate Baglan
    Port Talbot
    SA12 7BR

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.
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.

Miss Abbey Tufft
+44 (0)7794132994
abbey.tufft@plymouth.ac.uk


Prof Paul Taylor
+44 (0)1722 429 119
p.taylor@salisburyfes.com



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 Salisbury NHS Foundation Trust and funded by Efficacy and Mechanism Evaluation Programme.




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Read full details for Trial ID: ISRCTN13120555

Or CPMS 57258

Last updated 05 November 2024

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