Neuromuscular Electrical Stimulation in Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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. By combining comorbidity, stroke severity, and other demographic data it might be possible to get a greater knowledge about who will benefit from the intervention and early rehabilitation and that will be the a step towards personalized medicine in stroke rehabilitation.

Official Title
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Neuromuscular Electrical Stimulation in Acute Ischemic Stroke

Conditions
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Ischemic Stroke, Neuromuscular Electrical Stimulation, Exercise

Intervention / Treatment
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* Device: NMES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients with dementia and/or malign diseases Pregnancy Epilepsy 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel group, assessor blinded, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NMES<br>2 weeks (weekdays) of Neuromuscular Electrical Stimulation of the paretic lower limb during exercise. Each exercise session will last for 12 minutes and will consist of either walk or sit and raise from a chair. | Device: NMES<br>* Neuromuscular electrical stimulation of the paretic lower limb during exercise<br>|
| No Intervention: training<br>Participants will undergo 2 weeks of exercise every weekday. Each exercise session will last for 12 minutes and will consist of either walk or sit and raise from a chair. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The six Minute-Walk Test | 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. | Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Assessment | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia | Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks. | 
| Sit to stand | Sit-to-stand is a mechanically demanding task demanding task | Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks. | 
| Timed Up and Go | The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. | Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks. | 
| EuroQOL 5 domain | A self-reported outcome measure of health-related quality of life, covering 5 dimensions (movement, personal care, everyday activities, pain/discomfort and anxiety/depression). Is translated and validated for use in a Danish population. | Change from day 14 post ictus to day 90 post ictus. | 
| 10 meter walk test | The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a 10 meter distance. | Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks. | 
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal. | Change from day 14 post ictus to day 90 post ictus. | 
| Becks Depression Inventory | Becks Depression Inventory is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression | Change from day 14 post ictus to day 90 post ictus. | 
| Guralnik | Balance test assessed by the ability to stand for 10 seconds without support in each of the following positions: total feet, semitandem and full tandem | Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke, Neuromuscular electrical stimulation, Activities of daily living, Patient reported outcome, Fugl Meyer