CompletedNot ApplicableInterventional

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

Parkinson's disease can make walking difficult, leading to slow steps, freezing, and accidental falls. This clinical study is testing a wearable device called Functional Electrical Stimulation (FES). FES uses a small, battery-operated unit and sticky pads placed on the leg to deliver gentle electrical pulses to underactive muscles, helping lift the foot when walking. While already widely used for stroke and multiple sclerosis, researchers want to see if FES works well for Parkinson's. Participants are randomly placed into one of two groups: one continues their usual care alone, while the other uses FES alongside usual care for 18 weeks, followed by a 4-week break to check for lasting benefits. Researchers will measure walking speed, balance, and quality of life to see whether FES could become a standard NHS treatment to boost walking confidence and independence.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

Salisbury NHS Foundation Trust

Enrolment target

234

Start

01 Oct 2023

Estimated completion

31 May 2026

Parkinson's disease

What is this study about?

Many people living with Parkinson's experience changes in how they walk. You might find your steps becoming shorter or slower, or you might experience 'freezing', where your feet feel glued to the floor. These symptoms can increase the risk of trips and falls, making it harder to get out and enjoy daily activities like visiting the shops or using public transport.

This trial is exploring whether a technology called Functional Electrical Stimulation (FES) can help. FES uses a compact, battery-operated device that attaches to your leg with sticky pads. It sends mild electrical pulses to the nerves that lift your foot as you step forward. FES is already recommended by the NHS watchdog NICE for people recovering from strokes or living with multiple sclerosis, but we need more high-quality evidence to understand how well it works for Parkinson's.

In earlier small tests, people with Parkinson's who tried FES walked faster, fell less often, and felt more confident. Interestingly, many also noticed that their walking stayed better for days after turning the device off—a lasting benefit not usually seen in other conditions. This larger trial, led by Salisbury District Hospital, aims to confirm whether FES truly improves walking speed and quality of life so that health services like the NHS can decide whether to offer it routinely.

Key takeaways

Tests a gentle, wearable electrical device (FES) to help lift the foot and improve walking in Parkinson's.
Open to adults with Parkinson's who can walk 50 metres (with a walking aid if needed) without another person's help.
Half of participants will use the device for 18 weeks alongside usual care; half will continue usual care alone.
Measures changes in walking speed, balance, falls, and day-to-day confidence.
Led by Salisbury District Hospital and funded by the National Institute for Health and Care Research (NIHR).

Who may be eligible?

This study is open to adults aged 18 and older who have been diagnosed with Parkinson's disease and notice that it is affecting their walking. To join, your walking speed needs to be slightly slower than average due to your condition, and your symptoms should be between mild and moderate-to-advanced (stages 1 to 4 on the standard Parkinson's scale).

You must be able to stand up from a chair on your own and walk at least 50 metres. You are very welcome to use your normal walking aids, like a walking stick or frame, but you must be able to walk without another person physically supporting you.

Finally, you need to be able to understand the study instructions, take part in the tests, and give informed consent. If you have epilepsy, the team will discuss this carefully with you, as electrical stimulation can sometimes affect seizure activity.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older and diagnosed with Parkinson's disease.
Parkinson's causes me to walk more slowly or take smaller steps.
I can stand up from a chair by myself without another person lifting me.
I can walk at least 50 metres, using a cane or frame if necessary, without help from another person.
I am willing to attend clinic visits and follow the study instructions.

Answer every question to see your result.

What does participation involve?

If you join the trial, you will be randomly placed into one of two groups by a computer. One group will continue with their usual NHS Parkinson's care. The other group will use the FES device each day alongside their usual care.

If you are chosen to use the FES device, a specialist clinician will show you how to attach the pads and set the gentle stimulation to a comfortable level. You will use the device for 18 weeks, followed by a 4-week period where you stop using it so the team can see if any improvements last. In total, your active participation lasts around 22 weeks.

Throughout the study, researchers will measure your walking speed, balance, falls, and overall well-being. You will keep taking your prescribed Parkinson's medications as normal. A small group of 30 participants and their carers will also be invited to take part in an interview to share their personal thoughts on using the equipment.

Potential risks and benefits

Taking part may help improve your walking speed, balance, and confidence, although these benefits cannot be guaranteed. The findings could also help make FES widely available across the NHS in the future. The FES device is very safe and has been used for years in other conditions. The pulses feel like a mild 'pins and needles' sensation which most people quickly get used to, though you can adjust the settings if it feels too strong. Some people experience mild skin redness or irritation under the sticky pads. Taking part is completely voluntary, and you can stop using the device or leave the study at any time without your regular NHS medical care being affected in any way.

Locations (11)

Salisbury District Hospital
Approximate
Salisbury, England
Swansea Bay University Local Health Board
City only
Port Talbot, Wales
Leeds Teaching Hospitals NHS Trust
City only
Leeds, England
Salisbury District Hospital
Approximate
Salisbury, England
Morriston Hospital
Approximate
Swansea, Wales
Chapel Allerton Hospital
Unverified
Leeds, England
Moseley Hall Hospital
Unverified
Birmingham, England
Glan Clwd Hospital
Unverified
Rhyl, England
Wigton Hospital
Unverified
Wigton, England
Florence Nightingale Community Hospital
Unverified
Derby, England
Ipswich Hospital
Unverified
Ipswich, England

Common questions

Does the electrical stimulation hurt?

No, it should not be painful. It usually feels like a mild tingling or 'pins and needles.' The clinician will help you set it to a level that is comfortable for you.

Will I have to stop taking my usual Parkinson's medication?

No. You will continue to take all your regular medications exactly as prescribed by your doctor throughout the entire study.

Can I choose whether I receive the FES device?

No. To keep the test fair and scientifically reliable, a computer randomly assigns half the participants to receive the FES device and half to receive usual care alone.

What happens if the sticky pads irritate my skin?

Mild skin redness can occasionally happen. If your skin becomes sore, you can contact the study team, who will offer different pads or advise you on how to soothe the area.

Can I use my walking stick or frame during the trial?

Yes. You are encouraged to use whatever walking aids you normally use to stay safe and steady on your feet.

How to find out more

Abbey Tufft

abbey.tufft@plymouth.ac.uk +44 (0) 1752 439831 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.