Ischemic StrokeNESANCT03653312
Neuromuscular Electrical Stimulation in Acute Ischemic Stroke
A study testing NMES in people with Ischemic Stroke and Neuromuscular Electrical Stimulation, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Ischemic Stroke, Neuromuscular Electrical Stimulation, Exercise
- What is being tested?
- NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Aug 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with dementia and/or malign diseases
- Pregnancy
- Epilepsy
- Total loss of sensation
- Pacemaker
- Previous or current blood clot in the leg
Show all 10Show fewer
- Untreated depression
- Untreated alcohol or drug abuse
- Untreated hypertension
- Heart disease which limits function
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- NMES
- Keywords
- Ischemic Stroke, Neuromuscular electrical stimulation, Activities of daily living, Patient reported outcome, Fugl Meyer
- Medical subject headings
- Ischemic Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
Neuromuscular electrical stimulation of the paretic lower limb during exercise
| Study group | Role | What they receive |
|---|---|---|
| NMES | Active comparator | 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. Receives: Device: NMES |
| training | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
The six Minute-Walk Test
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.
Measured: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
Secondary outcomes (8)
Fugl Meyer Assessment
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
Measured: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
Sit to stand
Sit-to-stand is a mechanically demanding task demanding task
Measured: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
Timed Up and Go
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.
Measured: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
EuroQOL 5 domain
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.
Measured: Change from day 14 post ictus to day 90 post ictus.
10 meter walk test
The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a 10 meter distance.
Measured: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
Montreal Cognitive Assessment (MoCA)
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.
Measured: Change from day 14 post ictus to day 90 post ictus.
Becks Depression Inventory
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
Measured: Change from day 14 post ictus to day 90 post ictus.
Guralnik
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
Measured: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start27 Aug 2018
- Primary completion3 Jun 2020
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, assessor blinded, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Troels Wienecke, MD, PhD, Study director, Department of Neurology, Zealand University Hospital, University of Copenhagen, Roskilde, DenmarkHenriette Busk, PT, Principal investigator, Dept. of Neurology, Zealand University Hospital, and Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospital, Copenhagen UniversitySøren T Skou, PT, PhD, Study chair, University of Southern Denmark and Naestved-Slagelse-Ringsted HospitalsGert Kwakkel, Study chair, Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653312
- Sponsor's protocol ID
- REG-80-2015
- Acronym
- NESA
- Status last verified
- Jun 2020
- First submitted
- 28 Aug 2018
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03653312
- Acronym / sponsor ID
- NESA / REG-80-2015
- Keywords
- Ischemic Stroke, Neuromuscular electrical stimulation, Activities of daily living, Patient reported outcome, Fugl Meyer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group, assessor blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| NMES | Active comparator | Device: NMES2 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. |
| training | No intervention | –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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Patients with dementia and/or malign diseases
- Pregnancy
- Epilepsy
- Total loss of sensation
- Pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMESNeuromuscular electrical stimulation of the paretic lower limb during exercise | Device | NMES |
Primary outcome
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.
8 secondary outcomes
Fugl Meyer Assessment
Time frame: 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.
Timed Up and Go
Time frame: 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.
10 meter walk test
Time frame: 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.
Becks Depression Inventory
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troels Wienecke, MD, PhD study director
Department of Neurology, Zealand University Hospital, University of Copenhagen, Roskilde, Denmark
Henriette Busk, PT principal investigator
Dept. of Neurology, Zealand University Hospital, and Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospital, Copenhagen University
Søren T Skou, PT, PhD study chair
University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES in people with Ischemic Stroke and Neuromuscular Electrical Stimulation, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The six Minute-Walk Test (time frame: Primary endpoint: Change from baseline to 3 months. Secondary endpoint: Change from baseline to 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020; AzTrials last refreshed its copy on 31 Oct 2026.