Neuromuscular Electrical Stimulation in Acute Ischemic Stroke
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Exercise
- Ischemic Stroke
- Neuromuscular Electrical Stimulation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel group, assessor blinded, randomized controlled trialMasking: Single (Outcomes Assessor)Masking Description: One blinded outcome assessor (physiotherapists) will perform measurements of functional capacity, patient reported outcome, and cognition. 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
Participation Requirements
- Age
- Between 40 years and 85 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03653312
- Collaborators
- Not Provided
- 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
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