Title: A randomised controlled trial of the effectiveness of surface neuromuscular stimulation using the geko™ device compared with intermittent pneumatic compression to prevent venous thromboembolism in immobile acute stroke patients
Funder: Department of Health and Social Care

Abstract: Research question: Is the geko&trade; device more effective than intermittent pneumatic compression in the prevention of venous thromboembolism in immobile patients after stroke? Background: Venous thromboembolism (VTE) is a major health issue worldwide causing preventable death and long-term disability due to chronic leg swelling, pain, and venous stasis ulceration. Stroke patients are at particular risk because of immobility, comorbidities, and age. There is strong evidence that intermittent pneumatic compression of the legs via inflatable plastic sleeves (IPC) reduces VTE. However, 30 percent of patients have contraindications or cannot tolerate IPC. Non-invasive neuromuscular electrical stimulation of the peroneal nerve via the gekoTM device leads to muscle contraction and increases in venous blood flow in the legs. A service review at the University Hospital of North Midlands has shown that the device is well tolerated, and that providing gekoTM to patients who cannot use IPC significantly reduced VTE. Aim: To improve prevention of venous thromboembolism after stroke. Primary Objective: To determine whether the geko&trade; device is more effective at preventing venous thromboembolism (any symptomatic or asymptomatic DVT in the calf, popliteal or femoral veins or any PE) within 30 days of randomisation than intermittent pneumatic compression in immobile patients with acute stroke. Secondary Objectives: 1. To compare effectiveness and tolerability 2. To compare the survival, functional outcomes, and quality of life 3. To compare exploratory and health economic outcomes 4. To compare safety outcomes Trial design: Randomized controlled trial Setting: 10 acute stroke services in the UK Participants: Adults unable with a clinical diagnosis of acute stroke within 36 hours of symptom onset and who are unable to walk independently Intervention: The geko&trade; surface electrical stimulation device applied to both legs 24 hours a day for 30 days. Control: Intermittent pneumatic compression using any NHS approved device applied to both legs 24 hours a day for 30 days Follow-up: Clinical assessment and leg Dopplers at 1 and 2 weeks, clinical assessment at 30 days (or discharge) and by telephone at 90 days. Primary outcome: Any DVT or PE within 30 days of randomisation Secondary outcomes at 30 days: patient tolerance of the device, adherence to allocated treatment death, DVT, PE, Secondary outcomes at 90 days: Leg pain, death, DVT, PE, disability (modified Rankin Scale), quality of life, length of hospital stay, place of residence, readmissions, home time Study size: 1200 participants Timelines for delivery: Approvals and site set-up 6 months, recruitment 24 months, follow-up 3 months, analysis and reports 3 months. Anticipated impact and dissemination: Results will be presented at professional conferences and to lay audiences (Stroke Assembly), and published in high impact peer reviewed journals. Findings will feed into national and international stroke guidelines, and new or predicate clearances will be sought in all major, global markets. A positive outcome of the study will widen the number of patients who are able to benefit from effective VTE prevention reducing both DVT-related morbidity and PE-related deaths.

Lay abstract: Stroke patients are at high risk of venous thromboembolism (VTE). VTE is a condition in which a blood clot forms in a vein, usually in the veins of the legs. This is known as a deep vein thrombosis (DVT). The clot can dislodge and travel in the blood to the lung. This is very serious and is known as pulmonary embolism (PE). In 2013 a major clinical trial reported that 23% of stroke patients developed a DVT or PE. It is therefore important to use some method of prevention. Intermittent pneumatic compression (IPC) reduces this risk to 17% and has become the standard way of doing this. It works by inflating cuffs to move blood from the legs and to reduce the risk of clots from forming. But, because of other medical conditions, IPC cannot be used in a third of patietns. There is no safe and effective way of reducing DVT for this group. The applicants have developed a patented new method, the gekoTM, for preventing VTE. This is a small, battery-powered device that sticks to the back of the knee, where it gently stimulates a nerve, causing the muscles in the lower leg to contract and pump blood around the body. The device is recommended for use by UK medical authorities within the NHS for patients unable to tolerate other forms of VTE prevention. It is quickly fitted, and patients find it comfortable to wear. We have conducted a review of 2,000 acute stroke patients which shows that the device is safe and comfortable. As well as this, the introduction of the gekoTM device for patients that could not wear the IPC led to a 46% reduction in VTE compared to the time before the device was used. This has led to the theory that the geko&trade; device is more effective than IPC for prevention of VTE in patients with acute stroke. The aim of this project is to conduct a clinical trial to compare the gekoTM device with IPC in 1,200 patients to test this theory. We will involve stroke patients and their families in the design and management of this trial. We will also do the financial and environmental work to assess whether the gekoTM device saves money and is better for the environment than IPC when used in the NHS. To be able to export the device we need to make sure that we meet the medical device regulations for all of the market territories, such as the US, EU and Far East in which we will sell. This study will be run jointly by stroke survivors, clinical researchers, stroke physicians, academic staff at Keele University, and Firstkind Limited, the manufactures of the device.

Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS
Health categories: BLOOD;STROKE