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
Every year, around 30 percent of stroke patients who cannot use inflatable leg sleeves to prevent blood clots are left without an effective alternative. This trial tests whether a small electrical device worn on the leg—the geko™—can fill that gap. Blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) are a leading cause of preventable death and long-term disability after stroke. Standard prevention uses intermittent pneumatic compression (IPC), which works by inflating plastic sleeves around the legs. But a substantial minority of patients cannot tolerate IPC or have medical reasons not to use it. The geko™ device stimulates the peroneal nerve, causing the calf muscles to contract and push blood back toward the heart—a different mechanism that may be better tolerated. If the geko™ proves more effective than IPC at preventing clots within 30 days, it could become a routine option for stroke units across the NHS. That would mean fewer patients developing painful leg swelling, chronic ulcers, or dying from a clot that travels to the lungs. The trial will also compare survival, disability, quality of life, and cost-effectiveness, giving health services clear data on whether to adopt the device widely.
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Research question: Is the geko™ 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™ 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™ 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.
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