MonitoRing the Effect of Intermittent Pneumatic Compression and TRAnscutaneous Functional electrIcal Stimulation of the Common Peroneal Nerve Using the Geko® Device on Cerebral Haemodynamics in Patients With Ischaemic Strokes (The RETRAIN Trial Phase 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- Change in Cerebral Blood Flow During Device Use
研究概览
简要总结
Ischaemic strokes, caused by a disruption in the brain's blood supply, are the second leading cause of death and disability in the United Kingdom. This single-center prospective randomised study aims to measure cerebral blood flow and oxygen delivery in patients who have recently suffered an ischaemic stroke and are using either the geko® neuromuscular electrostimulation device or an intermittent pneumatic compression (IPC) device as part of their routine clinical care.
The geko® device stimulates a nerve in the lower leg, inducing muscle contractions that enhance blood circulation. The IPC device applies controlled external pressure through compressed air and a pump, cyclically inflating and deflating chambers in a sleeve worn on the leg. This mimics the action of calf muscles to promote blood flow.
The primary objective of this study is to assess the effect of the geko® and IPC devices on cerebral blood flow in stroke patients, specifically during the hyperacute phase (within 36 hours) following an ischaemic stroke. Both devices will be used as part of standard care for VTE prevention. Cerebral blood flow will be measured using functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG).
详细描述
This study is a randomised trial at a single centre, comparing brain blood flow and activity patterns when two standard treatments for preventing blood clots (VTE) are used following a stroke.
Who Can Take Part?
Patients will be identified for the study as part of their routine hospital care when they arrive at hospital through the emergency department. To take part they must:
- Be 18 years or older
- Have had an ischaemic stroke confirmed by a stroke doctor
- Be within 36 hours of stroke symptom onset
- Be unable to stand or move around
- Have had a CT or MRI scan confirming no bleeding in the brain
What Will Happen?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult over 18
- •Patient with ischaemic stroke diagnosis confirmed by a stroke physician.
- •Within 36 hours of symptom onset.
- •Unable to stand or mobilise without assistance.
- •No intracerebral haemorrhage as ruled out by computerised tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
排除标准
- •Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee.
- •Absence of a transient ischaemic attack (TIA).
- •Clinically apparent deep vein thrombosis at screening
- •Patient is expected to require palliative care within 14 days
- •No response to the geko® device i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting.
- •Contraindications for the use of the geko™ device
- •Allergy to hydrogel constituents
- •Contraindications to IPC
- •Severe peripheral vascular disease
- •Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion)
- •Severe oedema
- •Leg deformities making appropriate fitting impossible
- •Symptomatic congestive cardiac failure of NYHA class IV (symptoms of heart failure at rest, any physical activity causing further discomfort).
- •Single or double leg amputations.
- •Participation in any other clinical trial
- •Patients must not have a current coronavirus (COVID-19) infection
研究组 & 干预措施
Group 1 - IPC device
IPC sleeves applied bilaterally according to manufacturer's instructions for standard VTE prophylaxis following ischaemic stroke.
干预措施: Intermittent Pneumatic Compression (Device)
Group 2 - geko® device
The geko® device is a disposable, battery-powered neuromuscular electrostimulation device applied bilaterally to the peroneal nerve at the knee. It delivers low-frequency stimulation to activate the calf and foot muscle pumps, enhancing venous return and microcirculatory blood flow. Devices will be applied according to the manufacturer's instructions for VTE prophylaxis.
干预措施: geko® T3 (Device)
结局指标
主要结局
Change in Cerebral Blood Flow During Device Use
时间窗: Day 1-2 (within 36 hours of stroke onset; measurements taken twice daily for 2 consecutive days)
Cerebral blood flow (CBF) will be assessed using functional near-infrared spectroscopy (fNIRS) combined with EEG, beat-to-beat blood pressure, and transcutaneous CO₂ monitoring. Measurements will compare baseline (no device) to during active use of either the Intermittent Pneumatic Compression (IPC) device or the geko® T3 device. The primary analysis will evaluate differences in cerebral haemodynamics between the two randomized intervention groups.
次要结局
- Change in Neurovascular Coupling During Device Use(Day 1-2 (twice daily assessments for 2 consecutive days))
- Change in Dynamic Cortical Connectivity During Device Use(Day 1-2 (twice daily assessments for 2 consecutive days))
- Incidence of Adverse Events(Up to 2 days from enrolment)
- Incidence of Serious Adverse Events(Up to 2 days from enrolment)
- Incidence of Adverse Device Effects(Up to 2 days from enrolment)
- Incidence of Serious Adverse Device Effects(Up to 2 days from enrolment)
- Incidence of Device Deficiencies(Up to 2 days from enrolment)