Neuromuscular Electrical Stimulation in Acute Ischemic Stroke (NESA)

Zealand University Hospital

Status: Unknown

Conditions: Ischemic Stroke; Neuromuscular Electrical Stimulation; Exercise

Treatments: Device: NMES

Study type: Interventional

Funder types: Other

Identifiers

NCT03653312

REG-80-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

NMES

Active Comparator group

Description:

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.

Treatment:

Device: NMES

training

No Intervention group

Description:

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.