Clinical trial NCT03653312: Neuromuscular Electrical Stimulation in Acute Ischemic Stroke
Official title: Neuromuscular Electrical Stimulation in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Neuromuscular Electrical Stimulation
Exercise
Keywords: Ischemic Stroke
Neuromuscular electrical stimulation
Activities of daily living
Patient reported outcome
Fugl Meyer
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, assessor blinded, randomized controlled trial
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: The six Minute-Walk Test
timeFrame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
Secondary outcomes:
measure: Fugl Meyer Assessment
timeFrame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
measure: Sit to stand
timeFrame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
measure: Timed Up and Go
timeFrame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
measure: EuroQOL 5 domain
timeFrame: Change from day 14 post ictus to day 90 post ictus.
measure: 10 meter walk test
timeFrame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change from day 14 post ictus to day 90 post ictus.
measure: Becks Depression Inventory
timeFrame: Change from day 14 post ictus to day 90 post ictus.
measure: Guralnik
timeFrame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Department of Neurology
Study officials:
affiliation: Department of Neurology, Zealand University Hospital, University of Copenhagen, Roskilde, Denmark
name: Troels Wienecke, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of Neurology, Zealand University Hospital, and Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospital, Copenhagen University
name: Henriette Busk, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals
name: Søren T Skou, PT, PhD
role: STUDY_CHAIR
affiliation: Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, The Netherlands
name: Gert Kwakkel
role: STUDY_CHAIR
References: