Condition category
Circulatory System
Date applied
20/07/2015
Date assigned
28/07/2015
Last edited
28/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Neuromuscular electrical stimulation is a non-invasive, clinical method that has the potential to alleviate symptoms associated with immobilisation and disuse. Stimulation devices initiate involuntary, muscle contraction that result in a muscle-pump action. A clinical application of this is for patients undergoing orthopaedic surgery. These individuals are prone to develop deep-vein thrombosis (DVT), due to reduced blood circulation arising from muscle inactivity in bed-rest and hospitalisation. Clot formulation may arise due to blood vessel wall injury and blood pooling. Immobilisation after operations can contribute to blood pooling in the legs, due to a reduced muscle-pump action. This in turn increases DVT risk. What is not clearly understood is whether the patient’s leg position influences the muscular activity (and therefore the muscle-pump action) when receiving electrical stimulation. Existing counter-measures to promote leg circulation, such as compression stockings and automated devices, are restricted by bulk and discomfort. As a consequence, their effectiveness is limited due to poor compliance. However, electrostimulation devices, such as the Geko™, which send gentle electrical impulses to the leg muscles appear to improve leg circulation and reduce swelling. The Geko™ device is self-adhesive, wrist watch-shaped and attaches above the knee crease. Interestingly the Geko™ device appears to improve blood circulation according to leg position. We believe that if blood circulation is improved when Geko™ is applied at different leg positions, muscle activity may also vary. Whether the potential improvements in muscle activity then influences a person's balance remains to be seen. This is the aim of this initial observational study.

Who can participate?
Healthy adults aged 55 and above.

What does the study involve?
Participants are required to attend the Bournemouth University Exercise Physiology Laboratory on one occasion lasting around 2 hours to undergo leg Geko™ electrostimulation. Prior to the visit, the Chief Investigator will explain the study to each participant via telephone or in person, and by email. A patient information sheet (PIS) and a pre-test medical questionnaire will also be emailed or mailed to the individual to consider study participation. The visit will begin with participants providing verbal and written informed consent, and then completing a Physical Activity Scale for the Elderly (PASE) Questionnaire. The participant's Pre-test Health Questionnaire will be reviewed and approved prior to data collection.
Eligible participants will then have anthropometric measurements taken (height, weight, leg girth); this will be followed by electromyography (EMG) placement to record leg muscle activity. Participants will then perform standing balance tests whilst muscle activity is recorded. Next, the Geko™ device will positioned on the non-dominant leg and we will determine the individual's stimulation intensity in accordance to maximal participant tolerance. The Geko™ device will then be activated for 60 minutes with the participant seated. The knee joint will be positioned at 0°, 45° and 90° in a random order, each for 20 minutes. Muscle activity and self-reported discomfort will be measured throughout. Following Geko™ electrostimulation, anthropometry and balance tests will be repeated.

What are the possible benefits and risks of participating?
The Geko™ device is known to increase blood flow in healthy adults. We expect it to do the same for muscle activity in healthy, older adults, and alter according to leg position. There may also be a positive effect on swelling and standing balance, although we do not know yet if this is true. We will provide participants with transport to the Laboratory and refreshments during the visit. We do not expect any risk. The device is available commercially and has passed the national testing process and has been CE awarded. The use of the Geko™ device within this study has been acknowledged by the manufacturer. Once activated, the device sends small impulses through the skin to cause the foot and calf to twitch. This may be an unfamiliar sensation, but it should not cause pain or discomfort. Some older participants may have a skin reaction to the adhesive gel of the Geko™ device and EMG sensors. Participants will be compensated for their time and effort by provision of a £10 Amazon voucher.

Where is the study run from?
Bournemouth University - Exercise Physiology Laboratory (Faculty of Health and Social Sciences), UK

When is study starting and how long is it expected to run for?
June 2015 to October 2015 (recruitment from June 2015 to September 2015).

Who is the main contact?
Dr James Gavin
jgavin@bournemouth.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Gavin

ORCID ID

http://orcid.org/0000-0003-0574-0502

Contact details

Bournemouth University
Fern Barrow
Talbot Campus
Dorset
Poole
BH12 5BB
United Kingdom
+44 (0)7825884983
jgavin@bournemouth.ac.uk

Type

Scientific

Additional contact

Mr Thomas Wainwright

ORCID ID

http://orcid.org/0000-0001-7860-2990

Contact details

Room 306
Royal London House
Bournemouth University
Lansdwone Campus
Dorset
Bournemouth
BH1 3LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effects of Neuromuscular Electrical Stimulation of the common peroneal nerve on muscle activity, balance and proprioception of healthy, older adults: the influence of leg position

Acronym

NMES (Neuromuscular Electrical Stimulation)

Study hypothesis

We are studying the influence of leg position on a small electrostimulation device (on the common peroneal nerve), designed to promote limb blood circulation. Using the device in patients, we have observed that the electrostimulated, involuntary muscle contraction differs according to knee angle. We postulate that greater knee flexion angle may enhance the muscle activity during electrostimulation, in comparison to knee extension. Therefore, we are testing this in an observational pilot study in healthy older adults.

Ethics approval

Research Ethics Committee - Bournemouth University, 22/06/2015, ref: 8029

Study design

Observational; Pilot; Single-centre

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Condition: deep vein thrombosis, impaired peripheral venous circulation; Healthcare domain: bed-rest immobilisation and hospitalisation

Intervention

Geko device: small, neuromuscular electrostimulation device (over common peroneal nerve)

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Lower limb muscle activity (peroneus longus, tibialis anterior, and medial and lateral gastrocnemius) - 2. Static balance and proprioception
3. Oedema

All at baseline, during, and immediately after 60 minutes of electrostimulation.

Secondary outcome measures

1. Participant perceived discomfort (visual analogue scale and visual rating score)
2. Habitual physical activity (Physical Activity Scale for the Elderly (PASE) questionnaire)

All measured on a single occasion to establish measures in healthy older individuals.

Overall trial start date

29/06/2015

Overall trial end date

29/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 55 years and above
2. Good general health
3. Able to understand the Participant Information Sheet (PIS) and willing to sign the written Informed Consent form
4. Able and willing to follow the protocol requirements

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 20

Participant exclusion criteria

1. Has a neuromuscular, haematological and/or cardiovascular disorder
2. Has a pacemaker
3. Chronic obesity (body mass index (BMI) >40kg/m2)
4. Pregnancy
5. Recently undergone surgery and/or suffered illness
6. History or signs of previous superficial or deep vein thrombosis (DVT)/pulmonary embolism
7. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
8. Not able to fit the Geko electrostimulation device

Recruitment start date

01/06/2015

Recruitment end date

07/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bournemouth University
Faculty of Health and Social Sciences Bournemouth House 17-19 Christchurch Road
Bournemouth
BH1 3LH
United Kingdom

Sponsor information

Organisation

Bournemouth University

Sponsor details

Fern Barrow
Talbot Campus
Dorset
Poole
BH12 5BB
United Kingdom
+44 (0)1202 524111
enquiries@bournemouth.ac.uk

Sponsor type

University/education

Website

https://www1.bournemouth.ac.uk/

Funders

Funder type

University/education

Funder name

Bournemouth University

Alternative name(s)

BU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results of this study will be submitted for publication to an appropriate scientific conference and then peer-reviewed journal (e.g., Physical Therapy [impact factor, 3.2], Clinical Rehabilitation [impact factor, 2.1]) according to best practice.

The authors on the publication shall be the Chief Investigator, plus others deemed to have significantly contributed to the generation of the data and/or inputted to the study design and documentation.

Intention to publish date

30/12/2016

Participant level data

Available on request

Results - basic reporting

See additional file ISRCTN28232918_BasicResults_28Sep16

Publication summary

Publication citations

Additional files

Editorial Notes

28/09/2016: basic results summary uploaded.