<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03811106</url>
  </required_header>
  <id_info>
    <org_study_id>Firat University</org_study_id>
    <nct_id>NCT03811106</nct_id>
  </id_info>
  <brief_title>Neuromuscular Electrical Stimulation (NMES) in Stroke-diagnosed Individuals</brief_title>
  <official_title>Neuromuscular Electrical Stimulation (NMES) Applied to Back Extensors in Stroke Patients; Effects on Functional Capacity and Mobility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Firat University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Firat University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Specific clinical tools and treatment variables have a key role on the results to be&#xD;
      obtained. Therefore, there is a need for well-planned studies on the effect of Neuromuscular&#xD;
      Electrical Stimulation (NMES) on stroke patients. Although NMES is frequently used in&#xD;
      patients with stroke, scientific evidence regarding back extensor muscle stimulation,&#xD;
      functional capacity, balance and mobility efficiency in this patient group is not sufficient.&#xD;
      This study was planned to compare controlled individuals with neurological rehabilitation.&#xD;
      According to the definition of World Health Organization (WHO) stroke; It is a rapidly&#xD;
      developing clinical condition due to local or general impairment of brain functions, without&#xD;
      apparent cause other than vascular causes. In the world, the loss of disability and labor&#xD;
      force is known as the first and the second cause of deaths.&#xD;
&#xD;
      Post-stroke intensive care and rehabilitation processes vary between countries. For example,&#xD;
      in Australia, $ 2.14 billion is spent each year for the treatment of stroke-diagnosed&#xD;
      individuals, while US $ 65 million is spent annually. For these reasons, it is very important&#xD;
      to choose low-cost, effective and evidence-based physiotherapy approaches for people with&#xD;
      stroke. Hemiparesis, which is characterized by a loss of power on one side of the body, is&#xD;
      the most common neurological loss after stroke. Patients with hemiparetic stroke often have&#xD;
      impaired balance, mobility and functional capacity. This results in a high economic burden&#xD;
      and social problem in this person. Among the functional problems after stroke; impaired&#xD;
      balance, abnormal walking pattern with abnormal asymmetry, abnormal body and spinal movement&#xD;
      can be shown. The most important problem is the loss of mobility; bed activities include&#xD;
      sitting and standing. The most important goal of stroke rehabilitation is the recovery of&#xD;
      mobility and balance. Changes in walking pattern and balance abilities occur due to motor&#xD;
      control loss, spasticity, muscle weakness, joint motion deficit, abnormal movement patterns&#xD;
      and sensory dysfunction. In addition to neurophysiological treatment techniques such as&#xD;
      Bobath, conventional exercise programs, Brunnstrom and proprioceptive neuromuscular&#xD;
      parasilication, with the aim of improving the quality of movement and maintaining the balance&#xD;
      in rehabilitation of stroke-diagnosed patients, electrical stimulation is also used.Although&#xD;
      the importance of back extensor muscle strength is documented in the literature, it is&#xD;
      observed that studies focusing on back extensor muscle strength in limb rehabilitation are&#xD;
      limited.&#xD;
&#xD;
      Control disorders in the posterior extensor muscles after stroke are found to be&#xD;
      significantly associated with balance, gait and upper extremity dysfunctions.&#xD;
&#xD;
      Based on this idea, our study was planned to examine the effect of NMEs application on&#xD;
      functional capacity, balance and mobility in stroke individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our study will be carried out in Fırat University Training and Research Hospital. Individuals&#xD;
      who are diagnosed with stroke by the Physical Medicine and Rehabilitation Specialist and who&#xD;
      are directed to the physiotherapy program will be included. 20 hemiparesis patients who&#xD;
      underwent stimulation and conventional physiotherapy and rehabilitation of the back&#xD;
      extensors, will constitute 20 volunteer patients who only provided conventional physiotherapy&#xD;
      and rehabilitation applications. 20 cases were included in the study and 20 cases as control&#xD;
      group. All cases will be informed and approved before they start working.&#xD;
&#xD;
      Inclusion Criteria&#xD;
&#xD;
        1. Having a chart of hemiplegia or hemiparesis due to the first story of cerebrovascular&#xD;
           accident (SVO)&#xD;
&#xD;
        2. At least 3 months after SVO&#xD;
&#xD;
        3. Mini-mental State Examination (MMSE) value ≥ 15&#xD;
&#xD;
        4. Being in the 30 to 80 age range&#xD;
&#xD;
        5. Back extensor muscle spasticity value &lt;4 according to modified Ashworth Scale&#xD;
&#xD;
      Criteria for Inclusion of Patients in the Study&#xD;
&#xD;
        1. Ataxia, dystonia, dyskinesia&#xD;
&#xD;
        2. The presence of lower motor neuron or peripheral nerve lesion&#xD;
&#xD;
        3. Degraded deep senses&#xD;
&#xD;
        4. Detection disorder and dementia&#xD;
&#xD;
        5. Skin and peripheral circulatory disorder&#xD;
&#xD;
        6. History of CVO, bilateral hemiplegia&#xD;
&#xD;
      As demographic characteristics; age, gender, body weight, height of the patients, the hand&#xD;
      (dominant hemisphere), occupation and educational status, as a history of the disease; It&#xD;
      will be noted whether the patient has undergone SVO or transient ischemic attack. Our&#xD;
      neurological evaluation form; Reflexes, sensory defects, cranial nerve lesion, visual&#xD;
      disturbances, speech problem and type will be recorded.&#xD;
&#xD;
      All patients will be evaluated after treatment (TS). Spasticity will be graded from 0 to 5&#xD;
      according to the Modified Ashworth Scale.&#xD;
&#xD;
      Postural Assesment of Stroke Scale (PASS), Short Form-36, Adapted Patient Evaluation and&#xD;
      Conference System, Stroke Rehabilitation Assesment of Movement (STREAM), Brunel Balance&#xD;
      Assessment (BBA), Functional Ambulation Scale(FAS) and Mini-Mental State Examination (MMSE)&#xD;
      surveys and scales will be used.&#xD;
&#xD;
      Stimulation program, symmetrical biphasic waveform, 50 Hz frequency, 400 μs width flow&#xD;
      characteristics are used and the duration of treatment should be 30 min.&#xD;
&#xD;
      The current density will be adjusted to give full contraction of the back extensor muscle at&#xD;
      each warning. It will be adjusted separately in each session without any discomfort or pain.&#xD;
      In cases where contraction is reduced, the intensity of the current will be increased to&#xD;
      achieve the same quality contraction. However, the target muscles outside the muscles will&#xD;
      spread to the muscles strong enough to be created.&#xD;
&#xD;
      Statistical analysis of the study will be done with Statistical Package for Social Sciences&#xD;
      (SPSS) Version IBM Statistic 20. Mann Whitney U test will be used for the differences between&#xD;
      the two groups. Comparisons between the pre-treatment and post-treatment values of the&#xD;
      patients will be done by Wilcoxon Signed Rank test in dependent groups.&#xD;
&#xD;
      The obtained values will be expressed as mean ± standard deviation (SD). The differences&#xD;
      below p &lt;0.05 would be considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 4, 2019</start_date>
  <completion_date type="Anticipated">November 4, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized Controlled</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patient will not know the applications</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Effects on Functional Capacity and Mobility</measure>
    <time_frame>8 Months</time_frame>
    <description>Survey reviews</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brunnel Balance Scale:</measure>
    <time_frame>8 Months</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke Rehabilitation Assesment of Movement (STREAM)</measure>
    <time_frame>8 Months</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Ambulation Classification</measure>
    <time_frame>8 Months</time_frame>
    <description>Ambulation categories will be determined according to the Functional Ambulation Classification (FAS) developed by Massachusetts General Hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adapted Patient Evaluation and Conference System</measure>
    <time_frame>8 Months</time_frame>
    <description>The balance states of the patients will be evaluated with the evaluation form of Adapted Patient Evaluation and Conference System (APECS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postural Assesment of Stroke Scale (PASS)</measure>
    <time_frame>8 Months</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form-36</measure>
    <time_frame>8 Months</time_frame>
    <description>Quality of life is evaluated by the Short Form-36 health screening form.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini Mental State Examination Test</measure>
    <time_frame>8 Months</time_frame>
    <description>Cognitive functions will be evaluated on a total of 30 points</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2</enrollment>
  <condition>Hemiplegia</condition>
  <arm_group>
    <arm_group_label>NMES + PT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conventional physiotherapy and rehabilitation practices will be carried out.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeuromuscularElectricalStimulation+ConventionalPhysiotherapy</intervention_name>
    <description>Sırt ekstansör kaslarına nöromusküler elektrik stimülasyonu uygulanacaktır</description>
    <arm_group_label>NMES + PT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional physiotherapy and rehabilitation</intervention_name>
    <description>Konvansiyonel fizyoterapi ve rehabilitasyon uygulamaları yapılacaktır.</description>
    <arm_group_label>PT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Having a chart of hemiplegia or hemiparesis due to the first story of cerebrovascular&#xD;
             accident (SVO)&#xD;
&#xD;
          2. At least 3 months after SVO&#xD;
&#xD;
          3. Mini-mental State Examination (MMSE) value ≥ 15&#xD;
&#xD;
          4. Being in the 30 to 80 age range&#xD;
&#xD;
          5. Back extensor muscle spasticity value &lt;4 according to modified Ashworth Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ataxia, dystonia, dyskinesia&#xD;
&#xD;
          2. The presence of lower motor neuron or peripheral nerve lesion&#xD;
&#xD;
          3. Degraded deep senses&#xD;
&#xD;
          4. Detection disorder and dementia&#xD;
&#xD;
          5. Skin and peripheral circulatory disorder&#xD;
&#xD;
          6. History of CVO, bilateral hemiplegia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Marigold DS, Eng JJ. The relationship of asymmetric weight-bearing with postural sway and visual reliance in stroke. Gait Posture. 2006 Feb;23(2):249-55. doi: 10.1016/j.gaitpost.2005.03.001.</citation>
    <PMID>16399522</PMID>
  </reference>
  <reference>
    <citation>De Bujanda E, Nadeau S, Bourbonnais D. Pelvic and shoulder movements in the frontal plane during treadmill walking in adults with stroke. J Stroke Cerebrovasc Dis. 2004 Mar-Apr;13(2):58-69. doi: 10.1016/j.jstrokecerebrovasdis.2004.02.006.</citation>
    <PMID>17903951</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19942187</PMID>
  </reference>
  <reference>
    <citation>Hummelsheim H, Mauritz KH. [The neurophysiological basis of exercise physical therapy in patients with central hemiparesis]. Fortschr Neurol Psychiatr. 1993 Jun;61(6):208-16. doi: 10.1055/s-2007-999089. German.</citation>
    <PMID>8330831</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>10229728</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21504955</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23820295</PMID>
  </reference>
  <reference>
    <citation>Verheyden G, Nieuwboer A, Van de Winckel A, De Weerdt W. Clinical tools to measure trunk performance after stroke: a systematic review of the literature. Clin Rehabil. 2007 May;21(5):387-94. doi: 10.1177/0269215507074055.</citation>
    <PMID>17613559</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21844283</PMID>
  </reference>
  <reference>
    <citation>Verheyden G, Vereeck L, Truijen S, Troch M, Lafosse C, Saeys W, Leenaerts E, Palinckx A, De Weerdt W. Additional exercises improve trunk performance after stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):281-6. doi: 10.1177/1545968308321776. Epub 2008 Oct 27.</citation>
    <PMID>18955513</PMID>
  </reference>
  <reference>
    <citation>Tyson SF, DeSouza LH. Development of the Brunel Balance Assessment: a new measure of balance disability post stroke. Clin Rehabil. 2004 Nov;18(7):801-10. doi: 10.1191/0269215504cr744oa.</citation>
    <PMID>15573837</PMID>
  </reference>
  <reference>
    <citation>Daley K, Mayo N, Wood-Dauphinee S. Reliability of scores on the Stroke Rehabilitation Assessment of Movement (STREAM) measure. Phys Ther. 1999 Jan;79(1):8-19; quiz 20-3.</citation>
    <PMID>9920188</PMID>
  </reference>
  <reference>
    <citation>Huang YC, Wang WT, Liou TH, Liao CD, Lin LF, Huang SW. Postural Assessment Scale for Stroke Patients Scores as a predictor of stroke patient ambulation at discharge from the rehabilitation ward. J Rehabil Med. 2016 Mar;48(3):259-64. doi: 10.2340/16501977-2046.</citation>
    <PMID>26667386</PMID>
  </reference>
  <results_reference>
    <citation>English C, Hillier S. Circuit class therapy for improving mobility after stroke: a systematic review. J Rehabil Med. 2011 Jun;43(7):565-71. doi: 10.2340/16501977-0824.</citation>
    <PMID>21584485</PMID>
  </results_reference>
  <results_reference>
    <citation>de Oliveira CB, de Medeiros IR, Frota NA, Greters ME, Conforto AB. Balance control in hemiparetic stroke patients: main tools for evaluation. J Rehabil Res Dev. 2008;45(8):1215-26.</citation>
    <PMID>19235121</PMID>
  </results_reference>
  <results_reference>
    <citation>Benaim C, Perennou DA, Villy J, Rousseaux M, Pelissier JY. Validation of a standardized assessment of postural control in stroke patients: the Postural Assessment Scale for Stroke Patients (PASS). Stroke. 1999 Sep;30(9):1862-8. doi: 10.1161/01.str.30.9.1862.</citation>
    <PMID>10471437</PMID>
  </results_reference>
  <results_reference>
    <citation>Wade DT. Measurement in neurological rehabilitation. Curr Opin Neurol Neurosurg. 1992 Oct;5(5):682-6.</citation>
    <PMID>1392142</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Firat University</investigator_affiliation>
    <investigator_full_name>Furkan BİLEK</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Electrotherapy, Neuromuscular Electrical Stimulation, Stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemiplegia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03811106
org study id: Firat University
nct id: NCT03811106
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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

        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

      Criteria for Inclusion of Patients in the Study

        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

      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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled
primary purpose: Treatment
masking: Single (Participant)
masking description: Patient will not know the applications
measure: Effects on Functional Capacity and Mobility
time frame: 8 Months
description: Survey reviews
measure: Brunnel Balance Scale:
time frame: 8 Months
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
measure: Stroke Rehabilitation Assesment of Movement (STREAM)
time frame: 8 Months
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
measure: Functional Ambulation Classification
time frame: 8 Months
description: Ambulation categories will be determined according to the Functional Ambulation Classification (FAS) developed by Massachusetts General Hospital
measure: Adapted Patient Evaluation and Conference System
time frame: 8 Months
description: The balance states of the patients will be evaluated with the evaluation form of Adapted Patient Evaluation and Conference System (APECS).
measure: Postural Assesment of Stroke Scale (PASS)
time frame: 8 Months
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
measure: Short Form-36
time frame: 8 Months
description: Quality of life is evaluated by the Short Form-36 health screening form.
measure: Mini Mental State Examination Test
time frame: 8 Months
description: Cognitive functions will be evaluated on a total of 30 points
arm group label: NMES + PT
arm group type: Active Comparator
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 group label: PT
arm group type: Other
description: Conventional physiotherapy and rehabilitation practices will be carried out.
intervention type: Device
intervention name: NeuromuscularElectricalStimulation+ConventionalPhysiotherapy
description: Sırt ekstansör kaslarına nöromusküler elektrik stimülasyonu uygulanacaktır
arm group label: NMES + PT
intervention type: Other
intervention name: Conventional physiotherapy and rehabilitation
description: Konvansiyonel fizyoterapi ve rehabilitasyon uygulamaları yapılacaktır.
arm group label: PT
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
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responsible party type: Principal Investigator
investigator affiliation: Firat University
investigator full name: Furkan BİLEK
investigator title: Principal Investigator
mesh term: Hemiplegia
sharing ipd: No