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Neuromuscular Electrical Stimulation (NMES) in Stroke-diagnosed Individuals

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ClinicalTrials.gov Identifier: NCT03811106
Recruitment Status : Unknown
Verified February 2019 by Furkan BİLEK, Firat University.
Recruitment status was:  Not yet recruiting
First Posted : January 22, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Furkan BİLEK, Firat University

Brief Summary:

Specific clinical tools and treatment variables have a key role on the results to be obtained. Therefore, there is a need for well-planned studies on the effect of Neuromuscular Electrical Stimulation (NMES) on stroke patients. Although NMES is frequently used in patients with stroke, scientific evidence regarding back extensor muscle stimulation, functional capacity, balance and mobility efficiency in this patient group is not sufficient. This study was planned to compare controlled individuals with neurological rehabilitation. According to the definition of World Health Organization (WHO) stroke; It is a rapidly developing clinical condition due to local or general impairment of brain functions, without apparent cause other than vascular causes. In the world, the loss of disability and labor force is known as the first and the second cause of deaths.

Post-stroke intensive care and rehabilitation processes vary between countries. For example, in Australia, $ 2.14 billion is spent each year for the treatment of stroke-diagnosed individuals, while US $ 65 million is spent annually. For these reasons, it is very important to choose low-cost, effective and evidence-based physiotherapy approaches for people with stroke. Hemiparesis, which is characterized by a loss of power on one side of the body, is the most common neurological loss after stroke. Patients with hemiparetic stroke often have impaired balance, mobility and functional capacity. This results in a high economic burden and social problem in this person. Among the functional problems after stroke; impaired balance, abnormal walking pattern with abnormal asymmetry, abnormal body and spinal movement can be shown. The most important problem is the loss of mobility; bed activities include sitting and standing. The most important goal of stroke rehabilitation is the recovery of mobility and balance. Changes in walking pattern and balance abilities occur due to motor control loss, spasticity, muscle weakness, joint motion deficit, abnormal movement patterns and sensory dysfunction. In addition to neurophysiological treatment techniques such as Bobath, conventional exercise programs, Brunnstrom and proprioceptive neuromuscular parasilication, with the aim of improving the quality of movement and maintaining the balance in rehabilitation of stroke-diagnosed patients, electrical stimulation is also used.Although the importance of back extensor muscle strength is documented in the literature, it is observed that studies focusing on back extensor muscle strength in limb rehabilitation are limited.

Control disorders in the posterior extensor muscles after stroke are found to be significantly associated with balance, gait and upper extremity dysfunctions.

Based on this idea, our study was planned to examine the effect of NMEs application on functional capacity, balance and mobility in stroke individuals.


Condition or disease Intervention/treatment Phase
Hemiplegia Device: NeuromuscularElectricalStimulation+ConventionalPhysiotherapy Other: Conventional physiotherapy and rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled
Masking: Single (Participant)
Masking Description: Patient will not know the applications
Primary Purpose: Treatment
Official Title: Neuromuscular Electrical Stimulation (NMES) Applied to Back Extensors in Stroke Patients; Effects on Functional Capacity and Mobility
Estimated Study Start Date : March 4, 2019
Estimated Primary Completion Date : July 3, 2019
Estimated Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: NMES + PT
NMES will be applied to the back muscles with the chattanooga intelect advanced device. In addition, conventional physiotherapy and rehabilitation applications will be made.
Device: NeuromuscularElectricalStimulation+ConventionalPhysiotherapy
Sırt ekstansör kaslarına nöromusküler elektrik stimülasyonu uygulanacaktır

PT
Conventional physiotherapy and rehabilitation practices will be carried out.
Other: Conventional physiotherapy and rehabilitation
Konvansiyonel fizyoterapi ve rehabilitasyon uygulamaları yapılacaktır.




Primary Outcome Measures :
  1. Effects on Functional Capacity and Mobility [ Time Frame: 8 Months ]
    Survey reviews

  2. Brunnel Balance Scale: [ Time Frame: 8 Months ]
    It was developed to evaluate the effectiveness of rehabilitation approaches in stroke patients. Balance performance will be evaluated by 12 tests based on functional performance

  3. Stroke Rehabilitation Assesment of Movement (STREAM) [ Time Frame: 8 Months ]
    Specially designed by physiotherapists to ensure the quantitative assessment of motor function in patients with stroke. It is easy to perform in the clinic. The most important advantage of this scale is not only the breadth of active movement but also the quality of the movement. Evaluates voluntary movement and basic mobility separately

  4. Functional Ambulation Classification [ Time Frame: 8 Months ]
    Ambulation categories will be determined according to the Functional Ambulation Classification (FAS) developed by Massachusetts General Hospital

  5. Adapted Patient Evaluation and Conference System [ Time Frame: 8 Months ]
    The balance states of the patients will be evaluated with the evaluation form of Adapted Patient Evaluation and Conference System (APECS).

  6. Postural Assesment of Stroke Scale (PASS) [ Time Frame: 8 Months ]
    It is the scale used to evaluate postural control in stroke. It will be used to evaluate the static and dynamic balance of stroke patients

  7. Short Form-36 [ Time Frame: 8 Months ]
    Quality of life is evaluated by the Short Form-36 health screening form.

  8. Mini Mental State Examination Test [ Time Frame: 8 Months ]
    Cognitive functions will be evaluated on a total of 30 points



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Having a chart of hemiplegia or hemiparesis due to the first story of cerebrovascular accident (SVO)
  2. At least 3 months after SVO
  3. Mini-mental State Examination (MMSE) value ≥ 15
  4. Being in the 30 to 80 age range
  5. Back extensor muscle spasticity value <4 according to modified Ashworth Scale

Exclusion Criteria:

  1. Ataxia, dystonia, dyskinesia
  2. The presence of lower motor neuron or peripheral nerve lesion
  3. Degraded deep senses
  4. Detection disorder and dementia
  5. Skin and peripheral circulatory disorder
  6. History of CVO, bilateral hemiplegia
Publications of Results:
Other Publications:

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Responsible Party: Furkan BİLEK, Principal Investigator, Firat University
ClinicalTrials.gov Identifier: NCT03811106    
Other Study ID Numbers: Firat University
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Furkan BİLEK, Firat University:
Electrotherapy, Neuromuscular Electrical Stimulation, Stroke
Additional relevant MeSH terms:
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Hemiplegia
Nervous System Diseases
Paralysis
Neurologic Manifestations