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Neuromuscular Electrical Stimulation (NMES) in Stroke-diagnosed Individuals

Primary Purpose

Hemiplegia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NeuromuscularElectricalStimulation+ConventionalPhysiotherapy
Conventional physiotherapy and rehabilitation
Sponsored by
Firat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring Electrotherapy, Neuromuscular Electrical Stimulation, Stroke

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    NMES + PT

    PT

    Arm Description

    NMES will be applied to the back muscles with the chattanooga intelect advanced device. In addition, conventional physiotherapy and rehabilitation applications will be made.

    Conventional physiotherapy and rehabilitation practices will be carried out.

    Outcomes

    Primary Outcome Measures

    Effects on Functional Capacity and Mobility
    Survey reviews
    Brunnel Balance Scale:
    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
    Stroke Rehabilitation Assesment of Movement (STREAM)
    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
    Functional Ambulation Classification
    Ambulation categories will be determined according to the Functional Ambulation Classification (FAS) developed by Massachusetts General Hospital
    Adapted Patient Evaluation and Conference System
    The balance states of the patients will be evaluated with the evaluation form of Adapted Patient Evaluation and Conference System (APECS).
    Postural Assesment of Stroke Scale (PASS)
    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
    Short Form-36
    Quality of life is evaluated by the Short Form-36 health screening form.
    Mini Mental State Examination Test
    Cognitive functions will be evaluated on a total of 30 points

    Secondary Outcome Measures

    Full Information

    First Posted
    January 15, 2019
    Last Updated
    February 26, 2019
    Sponsor
    Firat University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03811106
    Brief Title
    Neuromuscular Electrical Stimulation (NMES) in Stroke-diagnosed Individuals
    Official Title
    Neuromuscular Electrical Stimulation (NMES) Applied to Back Extensors in Stroke Patients; Effects on Functional Capacity and Mobility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 4, 2019 (Anticipated)
    Primary Completion Date
    July 3, 2019 (Anticipated)
    Study Completion Date
    November 4, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Firat University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Our study will be carried out in Fırat University Training and Research Hospital. Individuals who are diagnosed with stroke by the Physical Medicine and Rehabilitation Specialist and who are directed to the physiotherapy program will be included. 20 hemiparesis patients who underwent stimulation and conventional physiotherapy and rehabilitation of the back extensors, will constitute 20 volunteer patients who only provided conventional physiotherapy and rehabilitation applications. 20 cases were included in the study and 20 cases as control group. All cases will be informed and approved before they start working. Inclusion Criteria Having a chart of hemiplegia or hemiparesis due to the first story of cerebrovascular accident (SVO) At least 3 months after SVO Mini-mental State Examination (MMSE) value ≥ 15 Being in the 30 to 80 age range Back extensor muscle spasticity value <4 according to modified Ashworth Scale Criteria for Inclusion of Patients in the Study Ataxia, dystonia, dyskinesia The presence of lower motor neuron or peripheral nerve lesion Degraded deep senses Detection disorder and dementia Skin and peripheral circulatory disorder History of CVO, bilateral hemiplegia As demographic characteristics; age, gender, body weight, height of the patients, the hand (dominant hemisphere), occupation and educational status, as a history of the disease; It will be noted whether the patient has undergone SVO or transient ischemic attack. Our neurological evaluation form; Reflexes, sensory defects, cranial nerve lesion, visual disturbances, speech problem and type will be recorded. All patients will be evaluated after treatment (TS). Spasticity will be graded from 0 to 5 according to the Modified Ashworth Scale. Postural Assesment of Stroke Scale (PASS), Short Form-36, Adapted Patient Evaluation and Conference System, Stroke Rehabilitation Assesment of Movement (STREAM), Brunel Balance Assessment (BBA), Functional Ambulation Scale(FAS) and Mini-Mental State Examination (MMSE) surveys and scales will be used. Stimulation program, symmetrical biphasic waveform, 50 Hz frequency, 400 μs width flow characteristics are used and the duration of treatment should be 30 min. The current density will be adjusted to give full contraction of the back extensor muscle at each warning. It will be adjusted separately in each session without any discomfort or pain. In cases where contraction is reduced, the intensity of the current will be increased to achieve the same quality contraction. However, the target muscles outside the muscles will spread to the muscles strong enough to be created. Statistical analysis of the study will be done with Statistical Package for Social Sciences (SPSS) Version IBM Statistic 20. Mann Whitney U test will be used for the differences between the two groups. Comparisons between the pre-treatment and post-treatment values of the patients will be done by Wilcoxon Signed Rank test in dependent groups. The obtained values will be expressed as mean ± standard deviation (SD). The differences below p <0.05 would be considered significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiplegia
    Keywords
    Electrotherapy, Neuromuscular Electrical Stimulation, Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Controlled
    Masking
    Participant
    Masking Description
    Patient will not know the applications
    Allocation
    Randomized
    Enrollment
    2 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NMES + PT
    Arm Type
    Active Comparator
    Arm Description
    NMES will be applied to the back muscles with the chattanooga intelect advanced device. In addition, conventional physiotherapy and rehabilitation applications will be made.
    Arm Title
    PT
    Arm Type
    Other
    Arm Description
    Conventional physiotherapy and rehabilitation practices will be carried out.
    Intervention Type
    Device
    Intervention Name(s)
    NeuromuscularElectricalStimulation+ConventionalPhysiotherapy
    Intervention Description
    Sırt ekstansör kaslarına nöromusküler elektrik stimülasyonu uygulanacaktır
    Intervention Type
    Other
    Intervention Name(s)
    Conventional physiotherapy and rehabilitation
    Intervention Description
    Konvansiyonel fizyoterapi ve rehabilitasyon uygulamaları yapılacaktır.
    Primary Outcome Measure Information:
    Title
    Effects on Functional Capacity and Mobility
    Description
    Survey reviews
    Time Frame
    8 Months
    Title
    Brunnel Balance Scale:
    Description
    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
    Time Frame
    8 Months
    Title
    Stroke Rehabilitation Assesment of Movement (STREAM)
    Description
    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
    Time Frame
    8 Months
    Title
    Functional Ambulation Classification
    Description
    Ambulation categories will be determined according to the Functional Ambulation Classification (FAS) developed by Massachusetts General Hospital
    Time Frame
    8 Months
    Title
    Adapted Patient Evaluation and Conference System
    Description
    The balance states of the patients will be evaluated with the evaluation form of Adapted Patient Evaluation and Conference System (APECS).
    Time Frame
    8 Months
    Title
    Postural Assesment of Stroke Scale (PASS)
    Description
    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
    Time Frame
    8 Months
    Title
    Short Form-36
    Description
    Quality of life is evaluated by the Short Form-36 health screening form.
    Time Frame
    8 Months
    Title
    Mini Mental State Examination Test
    Description
    Cognitive functions will be evaluated on a total of 30 points
    Time Frame
    8 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having a chart of hemiplegia or hemiparesis due to the first story of cerebrovascular accident (SVO) At least 3 months after SVO Mini-mental State Examination (MMSE) value ≥ 15 Being in the 30 to 80 age range Back extensor muscle spasticity value <4 according to modified Ashworth Scale Exclusion Criteria: Ataxia, dystonia, dyskinesia The presence of lower motor neuron or peripheral nerve lesion Degraded deep senses Detection disorder and dementia Skin and peripheral circulatory disorder History of CVO, bilateral hemiplegia

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16399522
    Citation
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    Results Reference
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    Results Reference
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    PubMed Identifier
    19942187
    Citation
    Esquenazi A, Ofluoglu D, Hirai B, Kim S. The effect of an ankle-foot orthosis on temporal spatial parameters and asymmetry of gait in hemiparetic patients. PM R. 2009 Nov;1(11):1014-8. doi: 10.1016/j.pmrj.2009.09.012.
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    PubMed Identifier
    10229728
    Citation
    Linn SL, Granat MH, Lees KR. Prevention of shoulder subluxation after stroke with electrical stimulation. Stroke. 1999 May;30(5):963-8. doi: 10.1161/01.str.30.5.963.
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    21504955
    Citation
    Karthikbabu S, Nayak A, Vijayakumar K, Misri Z, Suresh B, Ganesan S, Joshua AM. Comparison of physio ball and plinth trunk exercises regimens on trunk control and functional balance in patients with acute stroke: a pilot randomized controlled trial. Clin Rehabil. 2011 Aug;25(8):709-19. doi: 10.1177/0269215510397393. Epub 2011 Apr 19.
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    Citation
    Dragin AS, Konstantinovic LM, Veg A, Schwirtlich LB. Gait training of poststroke patients assisted by the Walkaround (body postural support). Int J Rehabil Res. 2014 Mar;37(1):22-8. doi: 10.1097/MRR.0b013e328363ba30.
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    Citation
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    Citation
    Saeys W, Vereeck L, Truijen S, Lafosse C, Wuyts FP, Heyning PV. Randomized controlled trial of truncal exercises early after stroke to improve balance and mobility. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):231-8. doi: 10.1177/1545968311416822. Epub 2011 Aug 15.
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    Neuromuscular Electrical Stimulation (NMES) in Stroke-diagnosed Individuals

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