Condition category
Nervous System Diseases
Date applied
27/03/2017
Date assigned
05/04/2017
Last edited
24/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parkinson’s disease (PD) is a long-term medical condition which is caused by the gradual loss of nerve cells (neurons) in a part of the brain called the substantia nigra. These neurons are normally responsible for producing dopamine, a chemical messenger (neurotransmitter) which carries signals around the brain that help to coordinate movement. In people suffering from PD, these neurons gradually die over time, causing the level of dopamine in the brain to gradually fall. As the levels of dopamine become lower, the brain is unable to coordinate movement as effectively, causing abnormal movements such as stiffness, tremor (uncontrollable shaking) and slowness of movement (bradykinesia). 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) is a technique which uses low energy electrical impulses to trigger useful movements in underactive muscles through small battery powered device worn on the leg. Previous studies have shown that patients with PD have been able to walk faster and have reduced symptoms after using FES. In order to carry out a large 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, it is important to run a small study to ensure the dull study is designed properly. The aim of this study is to look at the feasibility of conducting a study looking at the effectiveness to FES to see if a larger study would be possible.

Who can participate?
Adults with Parkinson’s disease who have walking difficulties.

What does the study involve?
Participants are first screened for their suitability for the study. If suitable they are invited back for an initial assessment which takes about 2 hours. Participants are then randomly allocated to one of two groups. Those in the first group continue to receive their usual care only for the duration of the study. There particiapnts return for follow up appointments after six, eight and 22 weeks at which the initial assessments are repeated. Those in the second group are invited to attend two appointments to learn how to use the equipment and followed up by the FES clinician at 6 and 18 weeks. At the 18 week appointment the FES device is returned to the clinic. As with those in the first group, these participants are also asked to attend assessment sessions at six, 18 and 22 weeks. At the end of the study, the number of participants who took part and those who completed all assessments is recorded to see if a larger study would be possible.

What are the possible benefits and risks of participating?
At the start of this study it is not known if people with Parkinson’s disease will benefit from using FES but reports from small short term studies indicate that walking may be made easier, faster and safer. While the long term safety of the technique has not been assessed for people with Parkinson’s, the technique has been extensively used in other patients groups such as multiple sclerosis and stroke. No serious side effects have been reported. The only regularly reported side effect from using FES is skin irritation under the electrodes (sticky pads via which the electric current is administered), effecting between 2.5% to 5% of device users.

Where is the study run from?
1. Salisbury District Hospital (UK)
2. The National Hospital for Neurology and Neurosurgery (UK)

When is the study starting and how long is it expected to run for?
April 2016 to April 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Paul Taylor
p.taylor@salisburyfes.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Taylor

ORCID ID

Contact details

Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
+44 1722 429119
p.taylor@salisburyfes.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30475

Study information

Scientific title

The effectiveness of peroneal nerve functional electrical stimulation (FES) for the reduction of bradykinesia in Parkinson’s disease: A pragmatic feasibility study for a single blinded randomised control trial (STEPS)

Acronym

STEPS

Study hypothesis

The aim of this study is to investigate the feasibility of conducting a randomised controlled trial to demonstrate that functional electrical stimulation (FES) applied to the common peroneal nerve while walking has a beneficial effect for people who have Parkinson's disease.

Ethics approval

South West - Cornwall & Plymouth Research Ethics Committee, 18/07/2016, ref: 16/SW/0041

Study design

Randomised; Interventional; Design type: Treatment, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.odstockmedical.com/knowledgebase/steps-participant-information

Condition

Specialty: Dementias and neurodegeneration, Primary sub-specialty: Parkinson's Disease; UKCRC code/ Disease: Neurological/ Other disorders of the nervous system

Intervention

Sixty-eight people with gait deficit due to idiopathic PD will be recruited. All participants will continue with usual care. In general, this comprises medication, attendance at medical clinics or visits from PD nurses. Exercise therapy may be accessed by individuals although this is not routinely prescribed. Participants will record usual care during the 22 week study.

The participants will be randomly allocated using computer generated randomisation to one of two groups.

Group 1 (control group): Participants will not receive any additional intervention over their usual care.

Group 2 (FES): Participants will use the device in addition to their usual care. FES will be delivered using a device called the ODFS Pace. Self-adhesive electrodes are placed over common peroneal nerve at its most superficial point just below the head of fibula. Stimulation is timed to the gait cycle using a pressure sensitive footswitch placed in the shoe and cause a contraction in the muscles that lift the foot and stabalise the ankle. As the foot is brought forward. The stimulator will be used daily when walking, throughout the intervention period. Participants will be taught to use the device over two clinic appointments with follow up 6 and 18 weeks.

Both groups will be assessed at weeks 0, 6, 18 and 22, (4 weeks after withdrawal of the device from group 2), by an assessor blind to the group allocation.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Recruitment rate is determined by comparing the number of people with PD in each service, the number of people approached and issued with and information sheet and the number of people who come forward for assessment with the number of people who are consented on to the study at baseline
2. Willingness to be randomised will be assessed by recording the number of people who drop out of the study because of what they consider unfavourable group allocation will be recorded, and through qualitative interviews with potential participants who do not wish to take part at or around baseline
3. Loss-to-follow rates will be determined by comparison of the number of participants who are consented for the study with the number of participants who complete the 22 week assessment
4. Participant views on obstacles to recruitment and retention in study using semi structure qualitative interviews at the beginning and end of the study
5. Participant views on what would constitute a meaningful primary outcome measure using semi structure qualitative interviews at the beginning and end of the study and study questionnaire at week 18

Secondary outcome measures

No secondary outcome measures.

Overall trial start date

01/04/2016

Overall trial end date

30/04/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years and above (no upper age limit)
2. Idiopathic Parkinson’s disease
3. Hoehn and Yahr stages I to IV under medication
4. Difficulty with gait (clinical observation by experienced clinician):
4.1. Reduced dorsiflexion or eversion at any point in the swing or weight acceptance phase of gait,
4.2. Bradykinesia demonstrated by a measured 10m walking speed of less than 1.25ms-1
4.3. Festination demonstrated by walking with short rapid strides
4.4. Akinesia demonstrated by exhibiting freezing episodes while walking. This may be in restricted areas such as doorways.
4.5. Hypokinesia demonstrated by walking with a short stride length
5. Able to walk 10m with appropriate walking aids but without assistance from another person
6. Able to obtain standing from sitting without the assistance of another person.
7. Medically stable defined as no significant changes in the participants condition over the last 3 months
8. Able to understand and comply with the treatment and assessment procedures
9. Able to give informed consent
10. Able to start using FES within 2 weeks

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 68; UK Sample Size: 68

Participant exclusion criteria

1. Able to walk 10m in less than 8s (walking speed >1.25ms-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 or dementia

Recruitment start date

01/05/2016

Recruitment end date

20/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom

Trial participating centre

The National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom

Sponsor information

Organisation

Salisbury NHS Foundation Trust

Sponsor details

Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
+44 1722 336262 Ext. 2027
stef.scott@salisbury.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned submission of a research report to the journal of Movement Disorders.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Paul Taylor (p.taylor@salisburyfes.com)

Intention to publish date

30/04/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.