xml: <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/NCT05975697</url>
    </required_header>
    <id_info>
      <org_study_id>CU-SBF-CK-01</org_study_id>
      <nct_id>NCT05975697</nct_id>
    </id_info>
    <brief_title>THE EFFECT OF FUNCTIONAL ELECTRICAL STIMULATING ON PHYSICAL ACTIVITY AND QUALITY OF LIFE IN PATIENTS WITH PARALIS AFTER THROMBECTOMY: A RANDOMIZED CONTROLLED STUDY</brief_title>
    <official_title>THE EFFECT OF FUNCTIONAL ELECTRICAL STIMULATING ON PHYSICAL ACTIVITY AND QUALITY OF LIFE IN PATIENTS WITH PARALIS AFTER THROMBECTOMY: A RANDOMIZED CONTROLLED STUDY</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cukurova University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cukurova 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>
        It is planned as a randomized controlled intervention study to determine the effect of&#xD;
        functional electrical stimulation (FES) on physical activity and quality of life in patients&#xD;
        with paralysis after thrombectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Thrombectomy is an interventional radiology procedure, and especially a method used&#xD;
        endovascularly, and is the removal of a blood clot formed in arteries and veins (Yıldırım,&#xD;
        2023). Timely restoration of cerebral blood flow using reperfusion therapy is the most&#xD;
        effective maneuver to save uninfarcted ischemic brain tissue (Jadhav at al., 2018). As the&#xD;
        benefit of reperfusion decreases over time, one of the most common complications as a result&#xD;
        of increasing ischemic areas is paralysis (Powers at al., 2019).&#xD;
  &#xD;
        Paralysis often leads to significant impairment in upper extremity function and is associated&#xD;
        with reduced quality of life in all domains except mobility (Franceschini at al., 2010). More&#xD;
        than half of the patients may become partially or completely dependent on others in daily&#xD;
        activities (Aşiret at al., 2013; Coban., 2013; Rahmani Anaraki at al., 2013; Kheirollahi at&#xD;
        al., 2013). However, few patients achieve full functional recovery, and this deficiency&#xD;
        impairs the performance of all physical activities, including self-care and social activities&#xD;
        (Kwakkel at al., 2003). Different therapeutic methods are used to prevent or reduce the&#xD;
        long-term deterioration of the upper extremities in patients undergoing thrombectomy (Vafadar&#xD;
        at al., 2015). Among these therapeutic methods, non-pharmacological methods are much easier&#xD;
        to learn, safe and without definite contraindications (Howlett at al., 2015).&#xD;
  &#xD;
        According to the studies reviewed, functional electrical stimulation (FES) is a&#xD;
        non-pharmacological method, which is a device that electrically stimulates motor neurons to&#xD;
        improve motor functions aimed at stimulating the nerves of weakened muscles (Lynch at al.,&#xD;
        2008; Niu, at al., 2022). Transcutaneous electrodes offer an easy and fast treatment option&#xD;
        because they are non-invasive (Eraifej at al., 2017).&#xD;
  &#xD;
        As a result of the literature review, FES (Bolton at al., 2004; Howlett at al., 2015; Meilink&#xD;
        at al., 2008; Vafadar at al., 2015; Van Peppen at al., 2004) has proven its effectiveness in&#xD;
        the rehabilitation of the lower extremity after thrombectomy. , and there is no clarity about&#xD;
        the effectiveness of FES in upper extremity rehabilitation (Stroke rehabilitation in adults.&#xD;
        Published June 2013. Accessed 1 Jan 2016). This is partly due to methodological limitations&#xD;
        (Howlett at al., 2015; Vafadar at al., 2015) or the outdated nature of some existing studies&#xD;
        (Bolton at al., 2004; Meilink at al., 2008; Van Peppen at al., 2004). ). It was also&#xD;
        highlighted by a recent Cochrane review that required a current review and meta-analysis of&#xD;
        randomized controlled trials (RCTs) on electrical stimulation (Pollock at al., 2014). The&#xD;
        most recent recent systematic review found a significant improvement in motor outcomes with&#xD;
        the upper extremity FES (Howlett at al., 2015).&#xD;
  &#xD;
        In this context, FES application in our country is one of the functional applications of&#xD;
        nurses to correct the activity with the doctor and to exercise management&#xD;
        (https://www.resmigazete.gov.tr/eskiler/2011/04/20110419-5.htm). In our study, we aimed to&#xD;
        base the effect of functional electrical stimulation (FES) on physical activity and quality&#xD;
        of life in patients with paralysis after thrombectomy, and to form a source for current and&#xD;
        similar studies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>Divided into two groups as experimental and control groups.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The study is planned to be double-blind, and the patient and the evaluating physician will not know which patient is in the study group and which patient is in the control group. The walkers and the physiotherapist will not be blind.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Fugl-Meyer Upper Extremity Motor Rating Scale (FMRS)</measure>
      <time_frame>5 days</time_frame>
      <description>To assess motor function, the Fugl Meyer Rating Scale (FMRS) considers the upper extremity in 3 parts. These parts are shoulder-elbow-forearm, (upper arm) wrist and hand. The score evaluation is 36 points for the upper arm, 10 points for the wrist and 14 points for the hand evaluation. In the evaluation of coordination and speed, the maximum total score of the upper extremity is 66, out of 6 points.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quick DASH (Arm Shoulder and Hand Injury Questionnaire Short Form)</measure>
      <time_frame>5 days</time_frame>
      <description>The questionnaire consists of 11 questions, and the difficulties of the patients during their daily living activities are examined. Each answer is scored from 1 to 5 on a Likert scale, from best to worst.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Thrombectomy</condition>
    <arm_group>
      <arm_group_label>Experimental group to be applied FES</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>FES treatment to the deltoid, triceps, extensor carpi radialis muscles for a total of 10 sessions, 30 minutes twice a day (in the morning and in the evening), for 5 days after the first 24th hour after the thrombectomy procedure in the experimental group patients (Program duration is 15 minutes and resting time is 15 minutes). minutes) will be applied.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>In the control group patients; From the first 24 hours after the thrombectomy procedure, the routine of the clinic (such as not performing a non-pharmacological procedure) is applied for 5 days, and no other procedure will be performed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Experimental group to be applied FES</intervention_name>
      <description>In the first 24 hours after the thrombectomy procedure, the relatives of the patients in the experimental and control groups who meet the inclusion criteria will be informed by the researcher and their consent will be obtained.&#xD;
  FES treatment to the deltoid, triceps, extensor carpi radialis muscles for a total of 10 sessions, 30 minutes twice a day (in the morning and in the evening), for 5 days after the first 24th hour after the thrombectomy procedure in the experimental group patients (Program duration is 15 minutes and resting time is 15 minutes). minutes) will be applied.Patient information form (Appendix 1), Fugl-meyer upper extremity motor assessment scale (Appendix-2) and Quick DASH (Arm, Shoulder and Hand Injury Questionnaire Short Form) (Appendix-3) were given to both groups within the first 24 hours after the thrombectomy procedure. ) will be applied. All patients will be re-evaluated before and on the 5th day after treatment.</description>
      <arm_group_label>Experimental group to be applied FES</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over 18 years old,&#xD;
  &#xD;
            -  Thrombectomy procedure was performed,&#xD;
  &#xD;
            -  Glasgow Coma Score (GCS) &gt; 12 after thrombectomy&#xD;
  &#xD;
            -  Able to communicate,&#xD;
  &#xD;
            -  Having upper extremity paralysis,&#xD;
  &#xD;
            -  No pacemaker, advanced spasticity and muscle atrophy, peripheral lesions,&#xD;
               osteoporosis, skin irritation and obesity,&#xD;
  &#xD;
            -  No skin and peripheral circulation problems,&#xD;
  &#xD;
            -  Patients whose relatives gave consent to the research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who did not comply with the sampling criteria and who developed complications&#xD;
               that caused brain damage during the study (convulsions, mental disorder/delirium,&#xD;
               vomiting, tremor, myoclonus) and whose relatives did not approve of the study will not&#xD;
               be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ceylan Kişial, Master</last_name>
      <phone>05068010561</phone>
      <email>cylnksl@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cansel Bozer, Master</last_name>
      <phone>05434332624</phone>
      <email>cansel9815@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Adana City Training and Research Hospital</name>
        <address>
          <city>Adana</city>
          <state>Yüreğir</state>
          <zip>01220</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ceylan Kişial, Master</last_name>
        <phone>05068010561</phone>
        <email>cylnksl@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Cansel Bozer</last_name>
        <phone>05434332624</phone>
        <email>cansel9815@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cukurova University</investigator_affiliation>
      <investigator_full_name>Ceylan Kisial</investigator_full_name>
      <investigator_title>PhD student</investigator_title>
    </responsible_party>
    <keyword>Thrombectomy</keyword>
    <keyword>FES</keyword>
    <keyword>PHYSICAL ACTIVITY</keyword>
    <keyword>LIFE QUALITY</keyword>
    <keyword>Nursing</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975697
  org study id: CU-SBF-CK-01
  nct id: NCT05975697
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  It is planned as a randomized controlled intervention study to determine the effect of
        functional electrical stimulation (FES) on physical activity and quality of life in patients
        with paralysis after thrombectomy.
  Thrombectomy is an interventional radiology procedure, and especially a method used
        endovascularly, and is the removal of a blood clot formed in arteries and veins (Yıldırım,
        2023). Timely restoration of cerebral blood flow using reperfusion therapy is the most
        effective maneuver to save uninfarcted ischemic brain tissue (Jadhav at al., 2018). As the
        benefit of reperfusion decreases over time, one of the most common complications as a result
        of increasing ischemic areas is paralysis (Powers at al., 2019).
  
        Paralysis often leads to significant impairment in upper extremity function and is associated
        with reduced quality of life in all domains except mobility (Franceschini at al., 2010). More
        than half of the patients may become partially or completely dependent on others in daily
        activities (Aşiret at al., 2013; Coban., 2013; Rahmani Anaraki at al., 2013; Kheirollahi at
        al., 2013). However, few patients achieve full functional recovery, and this deficiency
        impairs the performance of all physical activities, including self-care and social activities
        (Kwakkel at al., 2003). Different therapeutic methods are used to prevent or reduce the
        long-term deterioration of the upper extremities in patients undergoing thrombectomy (Vafadar
        at al., 2015). Among these therapeutic methods, non-pharmacological methods are much easier
        to learn, safe and without definite contraindications (Howlett at al., 2015).
  
        According to the studies reviewed, functional electrical stimulation (FES) is a
        non-pharmacological method, which is a device that electrically stimulates motor neurons to
        improve motor functions aimed at stimulating the nerves of weakened muscles (Lynch at al.,
        2008; Niu, at al., 2022). Transcutaneous electrodes offer an easy and fast treatment option
        because they are non-invasive (Eraifej at al., 2017).
  
        As a result of the literature review, FES (Bolton at al., 2004; Howlett at al., 2015; Meilink
        at al., 2008; Vafadar at al., 2015; Van Peppen at al., 2004) has proven its effectiveness in
        the rehabilitation of the lower extremity after thrombectomy. , and there is no clarity about
        the effectiveness of FES in upper extremity rehabilitation (Stroke rehabilitation in adults.
        Published June 2013. Accessed 1 Jan 2016). This is partly due to methodological limitations
        (Howlett at al., 2015; Vafadar at al., 2015) or the outdated nature of some existing studies
        (Bolton at al., 2004; Meilink at al., 2008; Van Peppen at al., 2004). ). It was also
        highlighted by a recent Cochrane review that required a current review and meta-analysis of
        randomized controlled trials (RCTs) on electrical stimulation (Pollock at al., 2014). The
        most recent recent systematic review found a significant improvement in motor outcomes with
        the upper extremity FES (Howlett at al., 2015).
  
        In this context, FES application in our country is one of the functional applications of
        nurses to correct the activity with the doctor and to exercise management
        (https://www.resmigazete.gov.tr/eskiler/2011/04/20110419-5.htm). In our study, we aimed to
        base the effect of functional electrical stimulation (FES) on physical activity and quality
        of life in patients with paralysis after thrombectomy, and to form a source for current and
        similar studies.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Divided into two groups as experimental and control groups.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The study is planned to be double-blind, and the patient and the evaluating physician will not know which patient is in the study group and which patient is in the control group. The walkers and the physiotherapist will not be blind.
  measure: Fugl-Meyer Upper Extremity Motor Rating Scale (FMRS)
  time frame: 5 days
  description: To assess motor function, the Fugl Meyer Rating Scale (FMRS) considers the upper extremity in 3 parts. These parts are shoulder-elbow-forearm, (upper arm) wrist and hand. The score evaluation is 36 points for the upper arm, 10 points for the wrist and 14 points for the hand evaluation. In the evaluation of coordination and speed, the maximum total score of the upper extremity is 66, out of 6 points.
  measure: Quick DASH (Arm Shoulder and Hand Injury Questionnaire Short Form)
  time frame: 5 days
  description: The questionnaire consists of 11 questions, and the difficulties of the patients during their daily living activities are examined. Each answer is scored from 1 to 5 on a Likert scale, from best to worst.
  arm group label: Experimental group to be applied FES
  arm group type: Experimental
  description: FES treatment to the deltoid, triceps, extensor carpi radialis muscles for a total of 10 sessions, 30 minutes twice a day (in the morning and in the evening), for 5 days after the first 24th hour after the thrombectomy procedure in the experimental group patients (Program duration is 15 minutes and resting time is 15 minutes). minutes) will be applied.
  arm group label: control group
  arm group type: No Intervention
  description: In the control group patients; From the first 24 hours after the thrombectomy procedure, the routine of the clinic (such as not performing a non-pharmacological procedure) is applied for 5 days, and no other procedure will be performed.
  intervention type: Other
  intervention name: Experimental group to be applied FES
  description: In the first 24 hours after the thrombectomy procedure, the relatives of the patients in the experimental and control groups who meet the inclusion criteria will be informed by the researcher and their consent will be obtained.
  FES treatment to the deltoid, triceps, extensor carpi radialis muscles for a total of 10 sessions, 30 minutes twice a day (in the morning and in the evening), for 5 days after the first 24th hour after the thrombectomy procedure in the experimental group patients (Program duration is 15 minutes and resting time is 15 minutes). minutes) will be applied.Patient information form (Appendix 1), Fugl-meyer upper extremity motor assessment scale (Appendix-2) and Quick DASH (Arm, Shoulder and Hand Injury Questionnaire Short Form) (Appendix-3) were given to both groups within the first 24 hours after the thrombectomy procedure. ) will be applied. All patients will be re-evaluated before and on the 5th day after treatment.
  arm group label: Experimental group to be applied FES
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ceylan Kişial, Master
  phone: 05068010561
  email: cylnksl@gmail.com
  last name: Cansel Bozer, Master
  phone: 05434332624
  email: cansel9815@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Cukurova University
  investigator full name: Ceylan Kisial
  investigator title: PhD student
  sharing ipd: No