Neuromuscular Electrical Stimulation in Acute Ischemic Stroke (NESA)

June 22, 2020 updated by: Zealand University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NMES

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
Neuromuscular electrical stimulation of the paretic lower limb during exercise
No Intervention: training
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
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
Time Frame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
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
Time Frame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
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
Time Frame: Change from day 14 post ictus to day 90 post ictus.
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
Time Frame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
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)
Time Frame: Change from day 14 post ictus to day 90 post ictus.
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
Time Frame: Change from day 14 post ictus to day 90 post ictus.
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
Time Frame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Study Director: Troels Wienecke, MD, PhD, Department of Neurology, Zealand University Hospital, University of Copenhagen, Roskilde, Denmark
  • Principal Investigator: Henriette Busk, PT, Dept. of Neurology, Zealand University Hospital, and Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospital, Copenhagen University
  • Study Chair: Søren T Skou, PT, PhD, University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals
  • Study Chair: Gert Kwakkel, Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2018

Primary Completion (Actual)

June 3, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-80-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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