<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/NCT03834311</url>
  </required_header>
  <id_info>
    <org_study_id>CukurovaPMR</org_study_id>
    <nct_id>NCT03834311</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia</brief_title>
  <official_title>The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia</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>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomised controlled study will investigate the effectiveness of isokinetic&#xD;
      strengthening on the upper extremity functionality and strength in post-stroke hemiplegic&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">November 15, 2019</completion_date>
  <primary_completion_date type="Actual">November 15, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>upper extremity strength</measure>
    <time_frame>0, 4, 8 weeks (change from baseline upper extremity strength at 4 weeks and at 8 weeks will be assessed)</time_frame>
    <description>Muscles: forearm flexors and extensors Measurement tool: MicroFET3 (Hoggan Health Industries Inc. West Jordan, UT, USA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pik torque</measure>
    <time_frame>0, 4, 8 weeks (change from baseline pik torque at 4 weeks and at 8 weeks will be assessed)</time_frame>
    <description>Muscles: wrist flexors and extensors Measurement Tool: CSMI Humac Norm Cybex isokinetic dinamometer (HUMAC® /2009 Version: 10.000.0065, Computer Sports Medicine Inc., USA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hand grip strength</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Measurement tool: Jamar Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment scale for upper extremity</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Scale range: 0-66; higher values represent a better outcome; subscales are combined by summing to compute a total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disabilities of the arm, shoulder and hand questionnaire (Part 1)</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Scale range: 0-100; higher scores represent more disabilities of the upper limb; Total score (sum of the scores for 30 questions) is put in a formula to compute the DASH disability score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale version 3.0</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Includes 8 domains and an extra assessment for stroke recovery; scores range 0-100 for each domain; higher scores represent better outcome; a formula is used for scoring each domain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Stroke Rehabilitation</condition>
  <condition>Hemiplegia</condition>
  <arm_group>
    <arm_group_label>isokinetic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>exercise band</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>isokinetic strengthening</intervention_name>
    <description>isokinetic upper extremity (forearm) strengthening for 4 weeks 3d/w</description>
    <arm_group_label>isokinetic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise band strengthening</intervention_name>
    <description>upper extremity (forearm) strengthening with exercise band 4 weeks 3d/w</description>
    <arm_group_label>exercise band</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active motion in upper extremity&#xD;
&#xD;
          -  Brunnstrom's Scale above 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable medical conditions&#xD;
&#xD;
          -  Cognitive problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>İlke COŞKUN BENLİDAYI</name>
      <address>
        <city>Adana</city>
        <zip>01330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>January 24, 2020</last_update_submitted>
  <last_update_submitted_qc>January 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cukurova University</investigator_affiliation>
    <investigator_full_name>Ilke Coskun Benlidayi</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hemiplegia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03834311
org study id: CukurovaPMR
nct id: NCT03834311
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This randomised controlled study will investigate the effectiveness of isokinetic
      strengthening on the upper extremity functionality and strength in post-stroke hemiplegic
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: upper extremity strength
time frame: 0, 4, 8 weeks (change from baseline upper extremity strength at 4 weeks and at 8 weeks will be assessed)
description: Muscles: forearm flexors and extensors Measurement tool: MicroFET3 (Hoggan Health Industries Inc. West Jordan, UT, USA)
measure: pik torque
time frame: 0, 4, 8 weeks (change from baseline pik torque at 4 weeks and at 8 weeks will be assessed)
description: Muscles: wrist flexors and extensors Measurement Tool: CSMI Humac Norm Cybex isokinetic dinamometer (HUMAC® /2009 Version: 10.000.0065, Computer Sports Medicine Inc., USA)
measure: hand grip strength
time frame: 0, 4, 8 weeks
description: Measurement tool: Jamar Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA)
measure: Fugl-Meyer Assessment scale for upper extremity
time frame: 0, 4, 8 weeks
description: Scale range: 0-66; higher values represent a better outcome; subscales are combined by summing to compute a total score
measure: Disabilities of the arm, shoulder and hand questionnaire (Part 1)
time frame: 0, 4, 8 weeks
description: Scale range: 0-100; higher scores represent more disabilities of the upper limb; Total score (sum of the scores for 30 questions) is put in a formula to compute the DASH disability score
measure: Stroke Impact Scale version 3.0
time frame: 0, 4, 8 weeks
description: Includes 8 domains and an extra assessment for stroke recovery; scores range 0-100 for each domain; higher scores represent better outcome; a formula is used for scoring each domain.
arm group label: isokinetic
arm group type: Experimental
arm group label: exercise band
arm group type: Active Comparator
intervention type: Device
intervention name: isokinetic strengthening
description: isokinetic upper extremity (forearm) strengthening for 4 weeks 3d/w
arm group label: isokinetic
intervention type: Other
intervention name: exercise band strengthening
description: upper extremity (forearm) strengthening with exercise band 4 weeks 3d/w
arm group label: exercise band
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Cukurova University
investigator full name: Ilke Coskun Benlidayi
investigator title: Associate Professor
mesh term: Stroke
mesh term: Hemiplegia
sharing ipd: Undecided