The influence of leg position on muscle activity during electrostimulation
| ISRCTN | ISRCTN28232918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28232918 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/07/2015
- Registration date
- 28/07/2015
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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 the study starting and how long is it expected to run for?
June 2015 to October 2015
Who is the main contact?
Dr James Gavin
jgavin@bournemouth.ac.uk
Contact information
Scientific
Bournemouth University
Fern Barrow
Talbot Campus
Dorset
Poole
BH12 5BB
United Kingdom
 ORCID ID |
0000-0003-0574-0502 |
|---|---|
| Phone | +44 (0)7825884983 |
| jgavin@bournemouth.ac.uk |
Scientific
Room 306
Royal London House
Bournemouth University
Lansdwone Campus
Dorset
Bournemouth
BH1 3LT
United Kingdom
| ORCID ID |
0000-0001-7860-2990 |
|---|
Study information
| Study design | Observational; Pilot; Single-centre |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| 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 |
| Study acronym | NMES (Neuromuscular Electrical Stimulation) |
| Study objectives | 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(s) | Research Ethics Committee - Bournemouth University, 22/06/2015, ref: 8029 |
| Health condition(s) or problem(s) studied | Deep vein thrombosis |
| Intervention | Geko device: small, neuromuscular electrostimulation device (over common peroneal nerve) |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | 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 study start date | 29/06/2015 |
| Completion date | 29/09/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 55 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 20 |
| Total final enrolment | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 07/09/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bournemouth House
17-19 Christchurch Road
Bournemouth
BH1 3LH
United Kingdom
Sponsor information
University/education
Fern Barrow
Talbot Campus
Dorset
Poole
BH12 5BB
England
United Kingdom
| Phone | +44 (0)1202 524111 |
|---|---|
| enquiries@bournemouth.ac.uk | |
| Website | https://www1.bournemouth.ac.uk/ |
"ROR" |
https://ror.org/05wwcw481 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- BU
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 28/09/2016 | 28/09/2016 | No | No | |
| Results article | 21/08/2018 | 18/08/2023 | Yes | No |
Additional files
- ISRCTN28232918_BasicResults_28Sep16.docx
- Uploaded 28/09/2016
Editorial Notes
18/08/2023: Publication reference and total final enrolment added.
28/09/2016: basic results summary uploaded.
