The Effectiveness of Peroneal Nerve Functional Electrical STimulation (FES) for theReduction of Bradykinesia in Parkinson’s Disease: A Pragmatic Feasibility Study for aSingle Blinded Randomised Control Trial (STEPS)

Study ID: 30475
Short Title: STEPS
Organisation: Salisbury NHS Foundation Trust
Location: Salisbury NHS Foundation Trust
Condition: Parkinson's disease
Main Specialty: Neurological disorders
Expected End Date: 30/03/2018
Postcode: SP2 8BJ
Contact Name: Louise Bell
Contact Email:
Active: Yes

Inclusion Criteria

1. Aged 18 years and above idiopathic Parkinson’s disease.

2. Hoehn and Yahr stages I to IV.

3. Difficulty with gait (includes any deficit in dorsiflexion or eversion, bradykinesia, festination, akinesia or hypokinesia).

4. Able to walk 10m with appropriate walking aids but without assistance from another person.

5. Medically stable.

6. Able to understand and comply with assessment procedures.

7. Able to give informed consent.

Exclusion Criteria

1. Able to walk 10m in less than 12.5s (walking speed >0.8ms-1) indicating non limited functional walking.

2. Other treatment than standard drug therapy (FES, deep brain stimulation, duodopa, apomorphine).

3. Atypical or secondary parkinsonism or parkinsonism related to other neurodegenerative diseases.

4. Dropped foot due to any neurological condition other than Parkinson’s Disease.

5. Untreated or refractory epilepsy.

6. Pregnancy.

7. Cardiac pacemaker, or other active medical implanted devices.

8. Denervation of the common peroneal nerve.

9. Malignancy or dermatological conditions in the area of the electrodes.

10. Major cognitive impairment? dementia.

Study 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.

In 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.

Sixty-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.

A 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.
Our 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.

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