Neuromuscular Electrical Stimulation in Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The six Minute-Walk Test
研究概览
简要总结
The purpose of the study is to examine the added effect of NeuroMuscular Electric Stimulation (NMES) in addition to exercise therapy in the acute phase of ischemic stroke.
This randomized controlled trial includes 50 patients allocated to either control or intervention.
The inclusion, test, training and re-test will be provided during the first 14 days after ictus, starting day 1 or 2 after ictus and a follow-up at day 90.
The exercise training with external NMES is done with the patient every weekday for 12 minutes.
详细描述
Stroke is the third most cause of disability in adults over 65 years of age worldwide. In 2008, 30.7 million people had survived a stroke. Every year, there are about 14,000 new cases of stroke in Denmark and the number is expected to rise with about 40% by 2035, due to the increasing population of elderly. Stroke survivors have the worst odds of reporting severe disability and the greatest variety of individual domains of disability compared to a range of other diseases. Therefore, these patients have essential rehabilitation needs. Little is known about who will benefit from functional interventional rehabilitation and what kind of intervention is best.
The purpose of the study is to examine the added effect of NeuroMuscular Electric Stimulation (NMES) in addition to exercise therapy in the acute phase of ischemic stroke.
This RCT includes 50 patients allocated to either control or intervention. The inclusion, test, training and re-test will be provided during the first 14 days after ictus, starting day 1 after ictus and a follow-up at day 90.
The exercise training with external NMES is done with the patient every weekday for 12 minutes.
If NMES increases functionality in acute stroke patients it would mean a greater degree of independence for individual patients and thus have the potential to improve on a major problem for society.
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
- Single (Outcomes Assessor)
盲法说明
One blinded outcome assessor (physiotherapists) will perform measurements of functional capacity, patient reported outcome, and cognition. Statistical analysis will be performed by a blinded statistician and a blinded interpretation of the results will be performed before breaking the randomization code.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic apoplexy and paresis in lower extremity, verified with picture diagnosis (CT/MR) or clinically diagnosed.
- •Leg palsy equalizes 2-4
- •Modified Ranking Scale(mRS) =0-1
- •Cognitive function adequate to participate
排除标准
- •Patients with dementia and/or malign diseases
- •Pregnancy
- •Total loss of sensation
- •Pacemaker
- •Previous or current blood clot in the leg
- •Untreated depression
- •Untreated alcohol or drug abuse
- •Untreated hypertension
- •Heart disease which limits function
结局指标
主要结局
The six Minute-Walk Test
时间窗: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
次要结局
- Fugl Meyer Assessment(Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.)
- Sit to stand(Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.)
- Timed Up and Go(Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.)
- EuroQOL 5 domain(Change from day 14 post ictus to day 90 post ictus.)
- 10 meter walk test(Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.)
- Montreal Cognitive Assessment (MoCA)(Change from day 14 post ictus to day 90 post ictus.)
- Becks Depression Inventory(Change from day 14 post ictus to day 90 post ictus.)
- Guralnik(Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.)