<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/NCT04425811</url>
  </required_header>
  <id_info>
    <org_study_id>pamukkaleU</org_study_id>
    <nct_id>NCT04425811</nct_id>
  </id_info>
  <brief_title>The Effect of Kinesiological Taping Applied to the Tibialis Anterior Muscle on Gait Parameter in Stroke Patients</brief_title>
  <official_title>The Effect of Kinesiological Taping Applied to the Tibialis Anterior Muscle on Gait Parameter in Stroke Patients: Sham Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Rumeli University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul Rumeli University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter&#xD;
      in stroke patients: Sham controlled study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The aim of this study was to compare the immediate effect of kinesiological and /&#xD;
      or sham taping to the tibialis anterior muscle on walking parameters in stroke individuals.&#xD;
&#xD;
      Methods: The study included 28 adults stroke patients . The subjects who received scores of 7&#xD;
      or more in the Hodkinson Mental Test and 3 and above in the Functional Ambulation&#xD;
      Classification with subjects who gastrocnemius muscle spasticity 2 and below points according&#xD;
      to Modified Ashworth Scale were included in the study. The walking parameters of the&#xD;
      participants were evaluated with the BTS G-Walk Spatio-Temporal Walking Analysis System. The&#xD;
      walking parameters of the participants who were selected by randomization method were&#xD;
      evaluated separately by applying kinesiological taping and sham taping or without any taping&#xD;
      or interference on a 10 meter track.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2018</start_date>
  <completion_date type="Actual">May 5, 2020</completion_date>
  <primary_completion_date type="Actual">July 22, 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>Sham Controlled Study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Original kinesiological tape was applied to the participants. Then sham banding application was done with sticking plaster tape.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>non-taping walking parameter measurement</measure>
    <time_frame>2 hours</time_frame>
    <description>The dominant side lower extremity of the participants was determined as the first preferred lower limb to take steps when walking. Walking parameters of the participants included in the study were evaluated with BTS G-Walk Spatio-Temporal Gait Analysis System. Before the banding applications of the patients, walking parameters were measured by asking them to walk with a shoe that they always use daily with the command &quot;walk normally&quot; on a 10-meter course, and stop with the command &quot;stop&quot; after 10 meters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>With kinesiological taping walking parameter measurement</measure>
    <time_frame>2 hours</time_frame>
    <description>Kinesiological taping or sham taping was performed by a certified physiotherapist 2 hours after the measurement of walking parameters without any intervention. Kinesiological banding for the tibialis anterior muscle was performed using muscle technique (stimulation). The taping was performed with the patients lying on a stretcher in the supine position. The kinesiological band was cut in the shape of I considering the participant's muscle length, the edges were ovalized, and the skin was purified from moisture, hair and oil. While applying the muscle technique (stimulation), the tibialis anterior muscle was stretched in the plantar flexion and eversion position. It was then activated by applying heat along the band. After the band was activated, the walking parameters of the participant were measured again with the BTS G-Walk device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>With sham taping walking parameter measurement</measure>
    <time_frame>2 hours</time_frame>
    <description>The sham taping was applied to the participants a week or a week before the application of the kinesiological tape. Sham taping application was applied to the same area as kinesiological taping application, but no technique was used. After the Sahm taping application, the walking parameters of the participants were measured again with the BTS G-Wlak device.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>No tape applied</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Walking parameters were evaluated without any intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesiological Tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Walking parameters were evaluated after kinesiological taping on the tibialis anterior muscle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham taping</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Walking parameters were evaluated after sham taping on the tibialis anterior muscle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>kinesiological taping</intervention_name>
    <description>The kinesiological banding applied to the tibialis anterior muscle was applied to improve walking parameters and compared to sham control.</description>
    <arm_group_label>Kinesiological Tape</arm_group_label>
    <arm_group_label>Sham taping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  28 stroke individuals (hemiplegic / hemiparetic) who were treated in the Adult&#xD;
&#xD;
          -  Neurological Rehabilitation Unit of Pamukkale University Medical Faculty Hospital were&#xD;
             included in the study.&#xD;
&#xD;
          -  Being between the ages of 25-70&#xD;
&#xD;
          -  Volunteers with written consent&#xD;
&#xD;
          -  With a 1-year history of stroke&#xD;
&#xD;
          -  Who had a stroke for the first time&#xD;
&#xD;
          -  Having a lesion in one brain hemisphere&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having neurological or orthopedic comorbid disease&#xD;
&#xD;
          -  Patients with a gastrocnemius spasticity greater than 2 according to the modified&#xD;
             ashworth scale&#xD;
&#xD;
          -  Patients with communication problems&#xD;
&#xD;
          -  Patients with cognitive functions below 7 points according to the Hodkinson Mental&#xD;
             Test&#xD;
&#xD;
          -  Patients with ambulation level below 3 according to Functional Ambulation&#xD;
             Classification&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emre Baskan, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Pamukkale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamukkale University</name>
      <address>
        <city>Denizli</city>
        <zip>20100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Rumeli University</investigator_affiliation>
    <investigator_full_name>Muammer Çorum</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Kinesiological Taping</keyword>
  <keyword>Walking</keyword>
  <keyword>Tibialis Anterior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT04425811
org study id: pamukkaleU
nct id: NCT04425811
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter
      in stroke patients: Sham controlled study
Objective: The aim of this study was to compare the immediate effect of kinesiological and /
      or sham taping to the tibialis anterior muscle on walking parameters in stroke individuals.

      Methods: The study included 28 adults stroke patients . The subjects who received scores of 7
      or more in the Hodkinson Mental Test and 3 and above in the Functional Ambulation
      Classification with subjects who gastrocnemius muscle spasticity 2 and below points according
      to Modified Ashworth Scale were included in the study. The walking parameters of the
      participants were evaluated with the BTS G-Walk Spatio-Temporal Walking Analysis System. The
      walking parameters of the participants who were selected by randomization method were
      evaluated separately by applying kinesiological taping and sham taping or without any taping
      or interference on a 10 meter track.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Sham Controlled Study
primary purpose: Other
masking: Single (Participant)
masking description: Original kinesiological tape was applied to the participants. Then sham banding application was done with sticking plaster tape.
measure: non-taping walking parameter measurement
time frame: 2 hours
description: The dominant side lower extremity of the participants was determined as the first preferred lower limb to take steps when walking. Walking parameters of the participants included in the study were evaluated with BTS G-Walk Spatio-Temporal Gait Analysis System. Before the banding applications of the patients, walking parameters were measured by asking them to walk with a shoe that they always use daily with the command "walk normally" on a 10-meter course, and stop with the command "stop" after 10 meters.
measure: With kinesiological taping walking parameter measurement
time frame: 2 hours
description: Kinesiological taping or sham taping was performed by a certified physiotherapist 2 hours after the measurement of walking parameters without any intervention. Kinesiological banding for the tibialis anterior muscle was performed using muscle technique (stimulation). The taping was performed with the patients lying on a stretcher in the supine position. The kinesiological band was cut in the shape of I considering the participant's muscle length, the edges were ovalized, and the skin was purified from moisture, hair and oil. While applying the muscle technique (stimulation), the tibialis anterior muscle was stretched in the plantar flexion and eversion position. It was then activated by applying heat along the band. After the band was activated, the walking parameters of the participant were measured again with the BTS G-Walk device.
measure: With sham taping walking parameter measurement
time frame: 2 hours
description: The sham taping was applied to the participants a week or a week before the application of the kinesiological tape. Sham taping application was applied to the same area as kinesiological taping application, but no technique was used. After the Sahm taping application, the walking parameters of the participants were measured again with the BTS G-Wlak device.
arm group label: No tape applied
arm group type: No Intervention
description: Walking parameters were evaluated without any intervention.
arm group label: Kinesiological Tape
arm group type: Experimental
description: Walking parameters were evaluated after kinesiological taping on the tibialis anterior muscle
arm group label: Sham taping
arm group type: Sham Comparator
description: Walking parameters were evaluated after sham taping on the tibialis anterior muscle
intervention type: Other
intervention name: kinesiological taping
description: The kinesiological banding applied to the tibialis anterior muscle was applied to improve walking parameters and compared to sham control.
arm group label: Kinesiological Tape
arm group label: Sham taping
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Emre Baskan, Phd
role: Study Director
affiliation: Pamukkale University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Rumeli University
investigator full name: Muammer Çorum
investigator title: Lecturer
mesh term: Stroke
sharing ipd: No