Condition category
Musculoskeletal Diseases
Date applied
05/06/2019
Date assigned
17/06/2019
Last edited
01/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Foot Electrical Muscle Stimulators often claim to boost the blood circulation in the legs thereby reliving symptoms such as swelling, heaviness, cramps, tiredness and pain. This study aims to investigate the effects of non-invasive EMS on the above leg symptoms among community-dwelling adults over the age of 65 years. We are comparing between three types of stimulators: two that will cause leg muscles to contract, and the third that wouldn’t cause any muscle contraction. The outcomes will be assessed using non-invasive measurement techniques and using brief questionnaires and interviews.

Who can participate?
Eligible participants will be adults over the age of 65 years who suffer from one or more of the following symptoms in one or both legs:
Swelling, mainly in the lower leg, ankle or foot.
Heaviness in the leg.
Cramps in the leg, mainly during the night or at rest.
Aching in the leg.
Tiredness in the leg.
Severe diabetes mellitus with severe diabetic neuropathy and any significant injury to the leg(s) in the last six months would make one ineligible. Also, active cancer and presence of any electronic implants (e.g. cardiac pacemaker) in the body are exclusions.

What does the study involve?
Participants will be involved in the study for 12 weeks attending a minimum of three face-to-face sessions, each lasting about two hours. They will be asked to attend the physiotherapy research laboratory in the Wright Building, College Lane Campus of the University of Hertfordshire to receive EMS treatment to their feet and allow some measurements to be taken from the legs and feet before and after treatment. They will also work through some questionnaires. Each session, which last around two hours, will include some paperwork, screening, treatment, and assessments. All these procedures are harmless, completely non-invasive and routinely employed in clinical practice and research. Participants will be randomly allocated to one of the three study groups. The group allocation will decide the type of EMS received. Of the three types of EMS, two will generate types of currents that will cause muscle contractions (motor stimulation). The third type will cause skin sensation but will not cause muscle contraction (sub motor/sensory stimulation). EMS will be delivered using ‘Revitive’ (Actegy Health Limited, Bracknell, UK). This is a CE-marked treatment device, which is already in use for several years and is available for over the counter purchase without prescription in the UK and many other countries. It is advocated for self-use where required, safely without the supervision of a clinician. Recipients are expected to experience ‘harmless mild electric stimulation’ in the Millivolt / Milliampere range that is typical to such stimulating devices. Depending on the group and the intensity of delivery chosen, either mild pins and needles or muscle contraction or both will be experienced. Participants will be screened for their ability to provide clear feedback upon their sensation of the stimulation. The intensity can be adjusted according to the sensation of the stimulation. On the first visit, after signing the consent form, participants will change to appropriate clothing (shorts or similar) and undergo some simple screening tests in their legs and thereafter height, weight and body composition measurements. After this they will undergo ‘pre-treatment measurements’ where the researcher will record normal baseline measures from the legs, work through the questionnaires and then talk through the experimental procedures, what to expect during the treatment and what to do if they have a problem. Subsequently, after 30 minutes of resting while they are in the lab the stimulation will be delivered for 30 minutes. If they feel any discomfort during the session they may ask the investigator to STOP the procedures. Localized application of EMS is safe and is not known to cause any significant effect elsewhere in the body. Hence, the chances of any injury are minimal. However, they will be given clear information regarding any potential hazard and the study will be terminated if they report any discomfort while receiving the treatment. If they are happy to continue with the study, a Revitive EMS machine will be given to take home and use at the required intensity level for 30 minutes twice daily for the next eight weeks. Participants will return to the lab (second visit) after using the device for eight weeks and again after four weeks from the second visit (third and final visit) for a follow-up. All tests will be repeated on both revisits.

What are the possible benefits and risks of participating?
There should be no harmful effects or disadvantages caused by participation in this study. The researcher will be near for the duration of the treatment and the tests to assist if necessary. The participants can always, at any moment, withdraw from the study. All the assessments are safe and have been used extensively in other research. On the other hand, it cannot be promised that the study will help the participants, but the information gathered from this study will help improve the knowledge base by providing a better understanding of the physiological mechanisms of action of EMS. People in the past have reported benefits from using similar device, and the current study will help to measure any such potential benefits. The information gained from this study will also help to plan the methodology of further research.

Where is the study run from?
University of Hertfordshire, UK

When is the study starting and how long is it expected to run for?
August 2019 To March 2020

Who is funding the study?
Actegy Health Limited, UK

Who is the main contact?
Dr Binoy Kumaran,
b.r.kumaran@herts.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Binoy Kumaran

ORCID ID

http://orcid.org/0000-0003-3125-0902

Contact details

Research Fellow in Physiotherapy
University of Hertfordshire
College Lane
Hatfield
AL10 9AB
United Kingdom
+441707289348
b.r.kumaran@herts.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

aHSK/SF/UH/03458(2)

Study information

Scientific title

The effect of an eight-week treatment programme using foot electrical muscle stimulator (EMS) on physical function and leg symptoms in community dwelling older adults: a randomised controlled trial

Acronym

Study hypothesis

The use of foot electrical muscle stimulator improves symptoms and function among people suffering from symptoms of peripheral arterial disease or chronic venous insufficiency in their legs.

Ethics approval

Approved 13/05/2019, Health Science Engineering & Technology Ethics Committee with Delegated Authority (ECDA) of the University of Hertfordshire (Governance Services Administrator (Ethics), Governance Services, University of Hertfordshire, Hatfield, AL10 9AB; +44(0)1707 285568; hsetecda@herts.ac.uk), ref: aHSK/SF/UH/03458(2)

Study design

Single-centre interventional study with a single-blind randomised controlled design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

See additional files

Condition

Symptoms of leg discomfort

Intervention

5. Participants will be randomised to three groups, each receiving a different type of foot electrical muscle stimulation, EMS (Group 1: EMS Type 1 in a low sensory mode; Group 2: EMS Type 2 in a standard motor mode; Group 3: EMS Type 3 in a high motor mode). The randomisation will be performed with concealed envelopes, which will be prepared a priori using a computer-generated randomisation chart (IBM SPSS Statistics, Version 23) and blinded from the participants. Each group will self-administer the treatment at home for 30 minutes twice daily (total one hour per day) for eight weeks. A baseline assessment will be carried out at WEEK ZERO for all participants prior to the start of the eight-week intervention. A post treatment assessment will be carried out at WEEK EIGHT at the end of the eight-week intervention period for all participants. All participants will again return for a 4-week post intervention follow-up assessment at WEEK TWELVE.

EMS will be delivered using Revitive™ machines (Actegy Health Limited). They will be administered in sitting position with the participants placing the soles of their feet on the rubberised foot plates. The machine is timed to run for 30 minutes continuously. The user can increase or decrease the intensity of treatment with a remote control. During the study all participants will continue with their normal life, activities, medications and diet with no restrictions attached.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Self-perception of performance in everyday living measured using the Canadian Occupational Performance Measure (COPM) at baseline, 8-weeks, 12-weeks.

Secondary outcome measures

1. Symptoms of heaviness, tiredness, aching and cramps in legs and feet in the preceding two weeks measured using a 0 - 10 NRS recorded in a symptom diary weekly from the end of week 1 to the end of week 7
2. Pain measured using 0 -10 VAS at baseline, 8-weeks, 12-weeks
3. Limb volume (for people with ankle and foot swelling) measured using a Perometer at baseline, 8-weeks, 12-weeks

Overall trial start date

01/10/2018

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Community-dwelling adults over the age of 65 affected by one or more of the following symptoms:
1. Swelling, mainly in the lower leg, ankle or foot.
2. Heaviness in the leg.
3. Cramps in the leg, mainly during the night or at rest.
4. Aching in the leg.
5. Tiredness in the leg.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Significant co-morbidities such as diabetic neuropathy.
2. Significant injury to the leg(s) in the last six months.
3. Active cancer.
4. Electronic implants in the body.
5. People who have recently used/currently using foot EMS.
6. Non-ambulant people.
7. Inability to consent or communicate in English.

Recruitment start date

01/07/2019

Recruitment end date

16/03/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Hertfordshire
Physiotherapy Research Lab LF311 College Lane
Hatfield
AL10 9AB
United Kingdom

Sponsor information

Organisation

Actegy Health Limited.

Sponsor details

REFLEX
Cain Road
Bracknell
RG12 1HL
United Kingdom
+441344636940
roseanna.penny@actegy.com

Sponsor type

Industry

Website

https://www.revitive.com

Funders

Funder type

Industry

Funder name

Actegy Health Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results to be published in a peer-reviewed international journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/07/2019: The participant information sheet was uploaded. 14/06/2019: Trial’s existence confirmed by Health Science Engineering & Technology Ethics Committee with Delegated Authority (ECDA) of the University of Hertfordshire