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Neuromuscular Electrical Stimulation in Acute Ischemic Stroke (NESA)

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ClinicalTrials.gov Identifier: NCT03653312
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

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. Further, to induce and measure neuroplasticity in the central nervous system during rehabilitation training.

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 after ictus and a follow-up at day 90.

The exercise training with external NMES is done with the patient every weekday for 27 minutes. The neural plasticity test will be performed using Transcranial Magnetic Stimulation (TMS).


Condition or disease Intervention/treatment Phase
Ischemic Stroke Neuromuscular Electrical Stimulation Transcranial Magnetic Stimulation Device: NMES Not Applicable

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. Further, to induce and measure neuroplasticity in the central nervous system during rehabilitation training.

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 27 minutes. The neural plasticity test will be performed using Transcranial Magnetic Stimulation (TMS).

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel group, assessor blinded, randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: One blinded outcome assessor (physiotherapists) will perform measurements of functional capacity, patient reported outcome, and cognition. The Transcranial Magnetic Stimulation will be performed by un-blinded physiotherapist. Statistical analysis will be performed by a blinded statistician and a blinded interpretation of the results will be performed before breaking the randomization code.
Primary Purpose: Treatment
Official Title: Neuromuscular Electrical Stimulation in Acute Ischemic Stroke
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

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 27 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 17 minutes and will consist of either walk or sit and raise from a chair.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. Timed Up and Go [ Time Frame: 12 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.

  4. EuroQOL 5 domain [ Time Frame: 12 weeks ]
    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.

  5. 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.

  6. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) [ Time Frame: Change from day 14 post ictus to day 90 post ictus. ]
    The IQCODE is a questionnaire which asks an informant about changes in an elderly person's everyday cognitive function. The questionnaire aims to assess cognitive decline independent of pre-morbid ability.

  7. 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.

  8. Trail Making Test [ Time Frame: Change from day 14 post ictus to day 90 post ictus. ]
    The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. It is sensitive to detecting cognitive impairment associated with dementia.

  9. Digit span forward and backward [ Time Frame: Change from day 14 post ictus to day 90 post ictus. ]
    A digit-span task is used to measure working memory's number storage capacity. Participants see or hear a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered. Digit-span tasks can be given forwards or backwards, meaning that once the sequence is presented, the participant is asked to either recall the sequence in normal or reverse order. Digit-span tasks are the most commonly used test for memory span, partially because performance on a digit-span task cannot be affected by factors such as semantics, frequency of appearance in daily life, complexity, etc

  10. Transcranial Magnetic Stimulation [ Time Frame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks. ]
    TMS is used diagnostically to measure the connection between the central nervous system and skeletal muscle to evaluate damage in a wide variety of disease states.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute ischemic apoplexy and paresis in lower extremity, verified with picture diagnosis (CT/MR)
  • Leg palsy equalizes 2-4
  • Modified Ranking Scale(mRS) =0
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653312


Contacts
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Contact: Henriette Busk, PT, MSc +45 23250898 hbus@regionsjaelland.dk
Contact: Troels Wienecke, MD, PhD +45 47322808 trw@regionsjaelland.dk

Locations
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Denmark
Department of Neurology Recruiting
Roskilde, Denmark, 4000
Contact: Troels Wienecke, MD, PhD    47322808    trw@regionsjaelland.dk   
Sponsors and Collaborators
Zealand University Hospital
Investigators
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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

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03653312     History of Changes
Other Study ID Numbers: REG-80-2015
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
Ischemic Stroke
Neuromuscular electrical stimulation
Activities of daily living
Patient reported outcome
Neuroplasticity
Transcranial magnetic stimulation
Fugl Meyer
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia