<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/NCT04468750</url>
  </required_header>
  <id_info>
    <org_study_id>5416</org_study_id>
    <nct_id>NCT04468750</nct_id>
  </id_info>
  <brief_title>Kinesiotaping Effect Glenohumeral Shoulder Subluxation</brief_title>
  <official_title>The Effect of Kinesiotaping on Glenohumeral Shoulder Subluxation in Post-stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Physical Medicine and Rehabilitation Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ankara Physical Medicine and Rehabilitation Education and Research Hospital</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>
      To evaluate the effectiveness of the kinesiotaping on pain, recovery of movement and daily&#xD;
      life activities in Turkish hemiplegic patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2013</start_date>
  <completion_date type="Actual">June 6, 2018</completion_date>
  <primary_completion_date type="Actual">July 15, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study is a quasi-experimental, single-subject AB design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subluxation degree by physical examination</measure>
    <time_frame>0-3weeks</time_frame>
    <description>A clinician measured the gap between the acromion and the humeral head with the fingerbreadth at the distal interphalangeal joint of the right index and middle fingers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subluxation degree by radiograph</measure>
    <time_frame>0-3weeks</time_frame>
    <description>The anterio-posterior shoulder X-ray was taken in an erect position, and subluxation was evaluated by Van Langenberghe's five point classification.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>physical examination</measure>
    <time_frame>0-3weeks</time_frame>
    <description>Passive range of motion (Flexion and Abduction)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the pain of the shoulder</measure>
    <time_frame>0-3weeks</time_frame>
    <description>Pain with motion was measured by a verbal descriptive pain scale. The VDPS was developed by Melzack and Katz and is composed of words such as &quot;mild&quot; (level 1) to &quot;very severe pain&quot; (level 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Daily life activities</measure>
    <time_frame>0-3weeks</time_frame>
    <description>Daily life activities were evaluated using the Katz index of independence in activities of daily living, which evaluates the patients in bathing, dressing, toileting, transferring, continence, and eating. Activities were scored as zero or one with the total score ranging from zero to six. Higher scores are related with higher independency.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Stroke</condition>
  <condition>Subluxation, Glenohumeral</condition>
  <arm_group>
    <arm_group_label>Kinesiotape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kinesiotape (Nasara, Korea) was applied for three times a week (Monday, Wednesday, and Friday) for three weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>kinesiotape</intervention_name>
    <description>During the rehabilitation program, all patients with GHS had kinesiotaping three times a week.</description>
    <arm_group_label>Kinesiotape</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) 18 to 90 years of age, (2) stroke onset within one year, (3) shoulder subluxation&#xD;
             in the involved upper extremity and (4) being oriented and cooperative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) global aphasia, (2) malignancy, (3) previous shoulder pain or surgery, (4) other&#xD;
             neuromuscular disorders and (5) severe cardiopulmonary disease that affects daily life&#xD;
             activities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Halil Ucan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Ankara Physical Medicine and Rehabilitation Education and Research Hospital</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 11, 2020</last_update_submitted>
  <last_update_submitted_qc>July 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Shoulder Dislocation</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/NCT04468750
org study id: 5416
nct id: NCT04468750
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the effectiveness of the kinesiotaping on pain, recovery of movement and daily
      life activities in Turkish hemiplegic patients.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study is a quasi-experimental, single-subject AB design.
primary purpose: Treatment
masking: None (Open Label)
measure: Subluxation degree by physical examination
time frame: 0-3weeks
description: A clinician measured the gap between the acromion and the humeral head with the fingerbreadth at the distal interphalangeal joint of the right index and middle fingers
measure: Subluxation degree by radiograph
time frame: 0-3weeks
description: The anterio-posterior shoulder X-ray was taken in an erect position, and subluxation was evaluated by Van Langenberghe's five point classification.
measure: physical examination
time frame: 0-3weeks
description: Passive range of motion (Flexion and Abduction)
measure: Evaluation of the pain of the shoulder
time frame: 0-3weeks
description: Pain with motion was measured by a verbal descriptive pain scale. The VDPS was developed by Melzack and Katz and is composed of words such as "mild" (level 1) to "very severe pain" (level 5)
measure: Evaluation of Daily life activities
time frame: 0-3weeks
description: Daily life activities were evaluated using the Katz index of independence in activities of daily living, which evaluates the patients in bathing, dressing, toileting, transferring, continence, and eating. Activities were scored as zero or one with the total score ranging from zero to six. Higher scores are related with higher independency.
arm group label: Kinesiotape
arm group type: Experimental
description: Kinesiotape (Nasara, Korea) was applied for three times a week (Monday, Wednesday, and Friday) for three weeks.
intervention type: Device
intervention name: kinesiotape
description: During the rehabilitation program, all patients with GHS had kinesiotaping three times a week.
arm group label: Kinesiotape
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Halil Ucan, MD
role: Study Director
affiliation: Ankara Physical Medicine and Rehabilitation Education and Research Hospital
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Shoulder Dislocation
sharing ipd: No