Neuromuscular Electrical Stimulation in Acute Ischemic Stroke
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Zealand University Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The six Minute-Walk Test
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
The six Minute-Walk Test
Time Frame: 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.
Secondary Outcomes
- 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.)