Clinical trial of electrical stimulation of leg muscles as a new way to prevent deep vein thrombosis and pulmonary embolism after stroke
| ISRCTN | ISRCTN11175235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11175235 |
| IRAS number | 315387 |
| ClinicalTrials.gov number | NCT05476913 |
| Secondary identifying numbers | FSK-VTE-001, IRAS 315387 |
- Submission date
- 08/09/2022
- Registration date
- 23/09/2022
- Last edited
- 17/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Venous thromboembolism (VTE) is a disabling and potentially fatal outcome that may be acquired in patients who are immobilised after an acute stroke. The standard treatment to prevent the development of VTE is to give anticoagulation medication. However, this is not recommended in the UK for patients who have had a stroke. Instead, the recommended treatment is intermittent pneumatic compression (IPC), where cuffs are placed around the lower legs and filled with air to help squeeze the legs and induce blood flow. However, not all patients are able to receive or tolerate IPC treatment. Another treatment which has shown promising results to prevent VTE in immobile patients after stroke is a medical device called the geko™ device. The geko™ device is a CE-marked medical device, which means the manufacturer has checked that the device complies with the essential safety and performance requirements for its intended use, which is to increase blood circulation to help prevent VTE. The aim of this study is to determine if the geko™ device is more effective at preventing VTE in immobile acute stroke patients, than the current IPC standard of care treatment.
Who can participate?
Immobile acute stroke patients aged 18 years or older
What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). One group of participants will be treated with the geko™ device, a small, self-adhesive electrostimulation device, which stimulates a nerve in the lower leg that causes the calf muscles to contract. This will be applied for 24 hours daily, until the participant recovers mobility, is discharged, or for a maximum of 30 days. The other group of participants will receive the standard of care IPC treatment, until the participant recovers mobility, is discharged, or for a maximum of 30 days. Compression Doppler imaging, which is a special type of ultrasound imaging, will be carried out to assess the participants for deep vein thrombosis (DVT) any time there is a clinical suspicion of DVT, and in addition at 7 days after randomisation or at discharge if earlier (optional compression Doppler) and/or 14 days after randomisation (mandatory visit). If indicated clinically, pulmonary embolism will be assessed by ventilation-perfusion scan or by computer tomography pulmonary angiogram (CTPA). Additional information including the NIH stroke score and adverse event information will be collected at 7 days (if practical) and 14 days after randomisation. At 14 days after randomisation, a device acceptability questionnaire and collection of other relevant information (e.g. final diagnosis, number of days in intensive care) will also be carried out. At 30 days after randomisation, information including incidences of symptomatic DVTs, PEs and antiplatelet/anticoagulation medication will be collected from medical notes. A final follow-up will be conducted 90 days after randomisation with the participant by phone (unless requested otherwise), to follow up on the participant's vital status, any DVT/PE diagnoses, as well as collecting information on the participant's health status and functional outcomes.
What are the possible benefits and risks of participating?
There are no guarantees that there are any direct benefits to the participant by participating in this study. However, the results of the study will help inform the recommended preventative treatment of venous thromboembolism for future immobile acute stroke patients, with the aim to improve recovery for patients. Participants will also contribute to the knowledge pool on the safety and performance of the geko™ device, which may also help improve treatment for future patients. There are no expected risks or disadvantages to participating in the study. Whichever group the participant is allocated to, their care will be overseen by their healthcare team. Some patients may develop a rash if they are allergic to the materials used in the study devices.
Where is the study run from?
Keele University (UK)
When is the study starting and how long is it expected to run for?
February 2021 to August 2025
Who is funding the study?
The National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Prof. Christine Roffe
christine.roffe@uhnm.nhs.uk
Contact information
Principal Investigator
Guy Hilton Research Building
Keele University
1 Thornburrow Drive
Stoke-on-Trent
ST4 7QB
United Kingdom
 ORCID ID |
0000-0002-5259-6649 |
|---|---|
| Phone | +44 (0)1782671655 |
| christine.roffe@uhnm.nhs.uk |
Public
Firstkind Limited
Hawk House
Gomm Road
High Wycombe
HP13 7DL
United Kingdom
| Phone | +44 (0)7827612109 |
|---|---|
| wing.to@firstkindmedical.com |
Scientific
Firstkind Limited
Hawk House
Gomm Road
High Wycombe
HP13 7DL
United Kingdom
| Phone | +44 (0)7921106253 |
|---|---|
| kieron.day@firstkindmedical.com |
Study information
| Study design | Prospective multicentre randomized controlled trial, single-blinded to the primary outcome |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised controlled trial of the effectiveness of intermittent surface neuromuscular stimulation using the geko™ device compared with intermittent pneumatic compression to prevent venous thromboembolism in immobile acute stroke patients |
| Study hypothesis | The geko™ neuromuscular electrical stimulation (NMES) device is more effective than intermittent pneumatic compression (IPC) at preventing venous thromboembolism (VTE) events in patients with acute stroke. |
| Ethics approval(s) |
Approved 21/02/2023, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 208 104 8051; gmsouth.rec@hra.nhs.uk), ref: 23/NW/0001 |
| Condition | Prevention of venous thromboembolism in acute stroke patients |
| Intervention | Current interventions as of 17/03/2025: This study is looking at venous thromboembolism (VTE) prevention in patients suffering an acute stroke. The Investigational arm will receive the geko™ device, a self-adhesive neuromuscular stimulator. This will be compared to the control arm using Intermittent Pneumatic Compression (IPC) as standard of care. Participants will be allocated to a treatment group via an online randomisation tool, applied centrally across the study sites. After randomisation, the participant will immediately receive their allocated treatment for 24 hours daily, until they can walk again without help, are discharged into the community, for a maximum of 30 days or other criteria are met including e.g. primary outcome has been met (VTE condition) and treatment dose / full dose anticoagulation treatment administered. Previous interventions: This study is looking at venous thromboembolism (VTE) prevention in patients suffering an acute stroke. The Investigational arm will receive the geko™ device, a self-adhesive neuromuscular stimulator. This will be compared to the control arm using Intermittent Pneumatic Compression (IPC) as standard of care. Participants will be allocated to a treatment group via an online randomisation tool, applied centrally across the study sites. After randomisation, the participant will immediately receive their allocated treatment for 24 hours daily, until they can walk again without help, are discharged, or for a maximum of 30 days. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | geko™ device |
| Primary outcome measure | Current primary outcome measure as of 17/05/2024: Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE) within 30 days of randomisation. DVT will be diagnosed using whole leg compression Doppler imaging, conducted any time there is a clinical suspicion of DVT and at 7 days (optional) and 14 days (mandatory) after randomisation. Previous primary outcome measure: Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE) within 30 days of randomisation. DVT will be diagnosed using whole leg compression Doppler imaging, conducted any time there is a clinical suspicion of DVT and at 7 days and 14 days after randomisation, or at patient discharge if the patient recovers within a 3-day window of these follow-up timepoints. |
| Secondary outcome measures | Current secondary outcome measure as of 17/05/2024: 1. Patient tolerability to either study device assessed using the Device Acceptability Questionnaire at 14 days after randomisation. 2. Device effectiveness based on the frequency of patient death for any cause, confirmed fatal or non-fatal PE, any (symptomatic or asymptomatic) above knee DVT and a combination of these outcomes at 30 days after randomisation. 3. Device effectiveness based on the frequency of any symptomatic or asymptomatic DVT in popliteal or femoral veins and symptomatic calf vein DVT at 30 days after randomisation. 4. Leg pain level measured using a Numerical Rating Score (NRS) at 90 days after randomisation. 5. Health-related quality of life measured using EQ-5D-5L, at baseline if possible and at 90 days after randomisation. 6. Patient survival at 90 days after randomisation. 7. The frequency of venous thromboembolism (any symptomatic or asymptomatic DVT or PE) occurring between randomisation and 90 days after randomisation. 8. Device safety assessed by documenting adverse event assessments up to 30 days after randomisation or at patient discharge if earlier. 9. Stroke-related neurologic deficit assessed using the NIH stroke scale (NIHSS) at 7 days and 14 days after randomisation. Previous secondary outcome measure: 1. Patient tolerability to either study device assessed using Device Acceptability Questionnaire at 30 days after randomisation or at patient discharge if earlier 2. Device effectiveness based on the frequency of patient death for any cause, confirmed fatal or non-fatal PE, any (symptomatic or asymptomatic) above knee DVT and a combination of these outcomes at 30 days after randomisation 3. Device effectiveness based on the frequency of any symptomatic or asymptomatic DVT in popliteal or femoral veins and symptomatic calf vein DVT at 30 days after randomisation 4. Leg pain level measured using a Numerical Rating Score (NRS) at 90 days after randomisation 5. Health-related quality of life measured using EQ-5D-5L, at baseline if possible and at 90 days after randomisation 6. Patient survival at 90 days after randomisation 7. The frequency of venous thromboembolism (any symptomatic or asymptomatic DVT or PE) occurring between randomisation and 90 days after randomisation 8. Device safety assessed by documenting adverse event assessments at 30 days after randomisation or at patient discharge if earlier 9. Stroke-related neurologic deficit assessed using the NIH stroke scale (NIHSS) at 7 days, 14 days and 30 days after randomisation or at patient discharge if the patient recovers earlier |
| Overall study start date | 23/02/2021 |
| Overall study end date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,200 |
| Participant inclusion criteria | 1. Aged 18 years or older 2. Clinical diagnosis of acute stroke (WHO criteria) 3. Within 36 hours of symptom onset 4. Not able to get up from a chair/out of bed and walk to the toilet without the help of another person |
| Participant exclusion criteria | 1. Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee 2. Unwitnessed onset with a long lie on the floor before admission 3. Clinically apparent deep vein thrombosis at screening 4. Patient is expected to require palliative care within 14 days 5. Patient does not live in the local catchment area and is expected to be transferred to their local hospital for ongoing care 6. Patient has recently been involved in or is currently involved in a clinical trial for either a medical device or medicinal product, within the past 3 months, with the exception: if co-enrolment is not considered to impact adverse events or outcomes in the opinion of the Chief Investigator 7. Contraindications for the use of the geko™ device: 7.1. Allergy to hydrogel constituents 8. Contraindications to IPC: 8.1. Severe peripheral vascular disease 8.2. Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion) 8.3. Severe oedema 8.4. Leg deformities making appropriate fitting impossible 8.5. Uncontrolled congestive cardiac failure 9. Pregnancy or breastfeeding 10. Single or double leg amputations |
| Recruitment start date | 06/07/2023 |
| Recruitment end date | 31/03/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Stoke-on-trent
ST4 6QG
United Kingdom
Bath
BA1 3NG
United Kingdom
Warrington Road
Prescot
L35 5DR
United Kingdom
Rochdale Old Road
Bury
BL9 7TD
United Kingdom
Bury Saint Edmunds
IP29 5DN
United Kingdom
Liverpool Road
Chester
CH2 1UL
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Stockport
SK2 7JE
United Kingdom
De Crespigny Park
Denmark Hill
London
SE5 8AB
United Kingdom
Edgbaston
Birmingham
B15 2GW
United Kingdom
Sponsor information
Industry
Hawk House
Peregrine Business Park
Gomm Road
High Wycombe
HP13 7DL
England
United Kingdom
| Phone | +44 (0)845 2222 921 |
|---|---|
| wing.to@firstkindmedical.com | |
| Website | https://www.gekodevices.com/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned dissemination of results via peer-reviewed scientific journals, national/international conferences and publication on website. Added 19/01/2023: The protocol has been submitted for the European Stroke Organisation Conference (ESOC) 2023. |
| IPD sharing plan | The study dataset generated during and/or analysed during the current study will be stored in a non-publicly available database (electronic data capture system). The database will be hosted by Medrio electronic data capture (EDC). This study dataset will be shared with Dr Martyn Lewis from the Clinical Trials Unit at Keele University, for analysis and generation of data summaries. This data may also be analysed and summarised by the study Sponsor, Firstkind Ltd. The (de-identified) compression Doppler images will be stored in an encrypted, external hard drive provided by the Sponsor for study purposes. These will then be transferred to a secure server in the UK. 5% of the compression Doppler images will be analysed by an independent sonographer for quality assurance purposes. Patients will be informed via the study Patient Information Sheet regarding the sharing of these de-identified datasets with the Sponsor and with the independent qualified experts. The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Christine Roffe (christine.roffe@uhnm.nhs.uk) after publication. |
Editorial Notes
17/03/2025: The following changes were made:
1. Study participating centres Queens Medical Centre, Northwick Park Hospital, Milton Keynes University Hospital, New Cross Hospital, Salford Royal Hospital, Yeovil District Hospital, Stepping Hill Hospital, Kings College Hospital and Queen Elizabeth Hospital were added.
2. The interventions were updated.
17/05/2024: The following changes were made:
1. The primary and Secondary outcome measures were updated.
2. Study participating centres West Suffolk Hospital, Countess of Chester Hospital, Royal Bournemouth General Hospital and Addenbrookes Hospital were added.
20/10/2023: The following changes were made to the trial record:
1. The ethics approval was added.
2. The study participating centres Whiston Hospital, Fairfield General Hospital were added.
06/07/2023: The following changes have been made:
1. The recruitment start date has been changed from 31/05/2023 to 06/07/2023.
2. Royal United Hospitals, Bath has been added to the study participating centres.
23/05/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/04/2023 to 31/05/2023.
2. The recruitment end date was changed from 30/04/2025 to 31/03/2025.
19/01/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/01/2023 to 01/04/2023.
2. The recruitment end date was changed from 30/03/2025 to 30/04/2025.
3. Publication and dissemination plan updated.
19/10/2022: The recruitment start date was changed from 01/10/2022 to 01/01/2023.
22/09/2022: Trial's existence confirmed by the NIHR.
