<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/NCT03263455</url>
  </required_header>
  <id_info>
    <org_study_id>KN2017</org_study_id>
    <nct_id>NCT03263455</nct_id>
  </id_info>
  <brief_title>Kinesio-Taping in Stroke Patients With Visuospatial Neglect</brief_title>
  <acronym>k-neglect</acronym>
  <official_title>The Effects of Kinesis-Taping Application on Cognitive Deficit and Motor Ability in Stroke Patients With Visuospatial Neglect: a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita di Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universita di Verona</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Stroke is the second leading cause of death worldwide and the third most common cause of&#xD;
      disability. The effects of stroke are variable and may include impairments in motor and&#xD;
      sensory systems, emotion and neuropsychological deficits such as a disorder of spatial&#xD;
      awareness known as unilateral spatial neglect (USN). Approaches to ameliorate USN could be&#xD;
      categorized in interventions as involving either bottom-up or top-down processing. The&#xD;
      specific mechanisms underlying these effects on a number of manifestations of the USN&#xD;
      syndrome may include the restoration of defective representations of the side of space&#xD;
      contralateral to the lesion (contralesional), and of the ability to orient spatial attention&#xD;
      contralesionally, through complex patterns of activation of both the damaged right&#xD;
      hemisphere, and the contralateral left hemisphere, with differences related to the specific&#xD;
      stimulation delivered to the patient. In recent years, increasing cutaneous stimuli through&#xD;
      neuromuscular kinesiotaping has been proposed to enhance somatosensory inputs (24) and such&#xD;
      as method could have positive effects on USN. The aim of the present study was to assess the&#xD;
      effect of KTM applied on the sternocleidomastoid muscle controlateral side of the lesions in&#xD;
      improving USN deficits in individuals with stroke patient in sub-acute phase. The hypothesis&#xD;
      is that the KTM application could improved cognitive tests for assessing USN, motor deficits&#xD;
      and kinesthetic neck sensibility.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2017</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Stars Cancellation Test change in number of stars deleted</measure>
    <time_frame>Baseline time 0 and up to 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of letter delete during the Letter Cancellation Test</measure>
    <time_frame>Baseline time 0 and up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Error assessed during the Cervical Joint Position Error Test</measure>
    <time_frame>Baseline time 0 and up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of Active Range of Motion (AROM) during left rotation</measure>
    <time_frame>Baseline time 0 and up to 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Stroke</condition>
  <condition>Motor Disorder</condition>
  <arm_group>
    <arm_group_label>Kinesio Taping group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The tape in the KT group was applied with paper-off tension, which means applying the tape directly to the skin as it comes off the paper backing (approximately with 15% to 25% of available tension).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Taping group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients in the ST group, smaller &quot;I-strips&quot; of KinesioTape were used and they were applied, with no tension and without stretching the muscles, perpendicularly to the muscle belly (starting from the middle and progressing to each side) over the same dystonic muscles as in the Kinesio Taping group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesio taping group</intervention_name>
    <description>The tape in the KT group will be applied with paper-off tension, which means applying the tape directly to the skin as it comes off the paper backing (approximately with 15% to 25% of available tension). KinesioTape will be applied over the SCM dystonic muscle by means of 2 &quot;I-strips&quot;: the first strip will be placed on the medial (sternal) head and the second will be applied on the lateral (clavicular) head of the SCM muscle. KinesioTape was applied from the mastoid bone to the clavicle (rostrocaudal direction) with the SCM placed in a position of maximum stretching.</description>
    <arm_group_label>Kinesio Taping group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Taping</intervention_name>
    <description>Patients in the ST group, smaller &quot;I-strips&quot; of KinesioTape will be used and they will be applied, with no tension and without stretching the muscles, perpendicularly to the muscle belly (starting from the middle and progressing to each side) over the same dystonic muscles as in the experimental group. Although the specific therapeutic elements of KinesioTaping (ie, longitudinal stretch, start and ending point tape application) will be removed</description>
    <arm_group_label>Sham Taping group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients affected by stroke from cerebral ischemia or hemorrhage that occurred ⩽ 30&#xD;
             days before;&#xD;
&#xD;
          -  presence of visuospatial neglect (Star Cancellation Test' score &lt; 50)&#xD;
&#xD;
          -  able to actively rotate the head toward left side in closed eyes condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of dementia (Mini-Mental State Examination correct score lower than&#xD;
             23,80)&#xD;
&#xD;
          -  severe deficit of comprehension&#xD;
&#xD;
          -  psychiatric disorders&#xD;
&#xD;
          -  hemianopsia patients (diagnosed with perimetry) patients or their family members did&#xD;
             not consent to this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicola Smania, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neuromotor and Cognitive Rehabilitation Center Department for Neurosciences, Biomedicine and Movement Sciences University of Verona, Verona, Italy P.zza L.A. Scuro, 10 37134 Verona, Italia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alessandro Picelli, MD</last_name>
    <role>Study Director</role>
    <affiliation>Neuromotor and Cognitive Rehabilitation Center Department for Neurosciences, Biomedicine and Movement Sciences University of Verona, Verona, Italy P.zza L.A. Scuro, 10 37134 Verona, Italia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Valentina Varalta, PS</last_name>
    <phone>00390458124950</phone>
    <email>valentina.varalta@univr.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniele Munari, PT</last_name>
    <phone>00390458124950</phone>
    <email>daniele.munari@univr.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Azienta Ospedaliera, SSO Rehabilitation Unit, Verona</name>
      <address>
        <city>Verona</city>
        <state>Italy, Verona</state>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienta Ospedaliera, SSO Rehabilitation Unit, Verona</name>
      <address>
        <city>Verona</city>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universita di Verona</investigator_affiliation>
    <investigator_full_name>Nicola Smania, MD, Clinical Professor</investigator_full_name>
    <investigator_title>Full Professor</investigator_title>
  </responsible_party>
  <keyword>neglect,</keyword>
  <keyword>stroke,</keyword>
  <keyword>rehabilitation,</keyword>
  <keyword>range of motion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Motor Disorders</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/NCT03263455
org study id: KN2017
nct id: NCT03263455
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Stroke is the second leading cause of death worldwide and the third most common cause of
      disability. The effects of stroke are variable and may include impairments in motor and
      sensory systems, emotion and neuropsychological deficits such as a disorder of spatial
      awareness known as unilateral spatial neglect (USN). Approaches to ameliorate USN could be
      categorized in interventions as involving either bottom-up or top-down processing. The
      specific mechanisms underlying these effects on a number of manifestations of the USN
      syndrome may include the restoration of defective representations of the side of space
      contralateral to the lesion (contralesional), and of the ability to orient spatial attention
      contralesionally, through complex patterns of activation of both the damaged right
      hemisphere, and the contralateral left hemisphere, with differences related to the specific
      stimulation delivered to the patient. In recent years, increasing cutaneous stimuli through
      neuromuscular kinesiotaping has been proposed to enhance somatosensory inputs (24) and such
      as method could have positive effects on USN. The aim of the present study was to assess the
      effect of KTM applied on the sternocleidomastoid muscle controlateral side of the lesions in
      improving USN deficits in individuals with stroke patient in sub-acute phase. The hypothesis
      is that the KTM application could improved cognitive tests for assessing USN, motor deficits
      and kinesthetic neck sensibility.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The Stars Cancellation Test change in number of stars deleted
time frame: Baseline time 0 and up to 4 weeks
measure: Number of letter delete during the Letter Cancellation Test
time frame: Baseline time 0 and up to 4 weeks
measure: Number of Error assessed during the Cervical Joint Position Error Test
time frame: Baseline time 0 and up to 4 weeks
measure: Degree of Active Range of Motion (AROM) during left rotation
time frame: Baseline time 0 and up to 4 weeks
arm group label: Kinesio Taping group
arm group type: Experimental
description: The tape in the KT group was applied with paper-off tension, which means applying the tape directly to the skin as it comes off the paper backing (approximately with 15% to 25% of available tension).
arm group label: Sham Taping group
arm group type: Sham Comparator
description: Patients in the ST group, smaller "I-strips" of KinesioTape were used and they were applied, with no tension and without stretching the muscles, perpendicularly to the muscle belly (starting from the middle and progressing to each side) over the same dystonic muscles as in the Kinesio Taping group
intervention type: Other
intervention name: Kinesio taping group
description: The tape in the KT group will be applied with paper-off tension, which means applying the tape directly to the skin as it comes off the paper backing (approximately with 15% to 25% of available tension). KinesioTape will be applied over the SCM dystonic muscle by means of 2 "I-strips": the first strip will be placed on the medial (sternal) head and the second will be applied on the lateral (clavicular) head of the SCM muscle. KinesioTape was applied from the mastoid bone to the clavicle (rostrocaudal direction) with the SCM placed in a position of maximum stretching.
arm group label: Kinesio Taping group
intervention type: Other
intervention name: Sham Taping
description: Patients in the ST group, smaller "I-strips" of KinesioTape will be used and they will be applied, with no tension and without stretching the muscles, perpendicularly to the muscle belly (starting from the middle and progressing to each side) over the same dystonic muscles as in the experimental group. Although the specific therapeutic elements of KinesioTaping (ie, longitudinal stretch, start and ending point tape application) will be removed
arm group label: Sham Taping group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Nicola Smania, MD
role: Principal Investigator
affiliation: Neuromotor and Cognitive Rehabilitation Center Department for Neurosciences, Biomedicine and Movement Sciences University of Verona, Verona, Italy P.zza L.A. Scuro, 10 37134 Verona, Italia
last name: Alessandro Picelli, MD
role: Study Director
affiliation: Neuromotor and Cognitive Rehabilitation Center Department for Neurosciences, Biomedicine and Movement Sciences University of Verona, Verona, Italy P.zza L.A. Scuro, 10 37134 Verona, Italia
last name: Valentina Varalta, PS
phone: 00390458124950
email: valentina.varalta@univr.it
last name: Daniele Munari, PT
phone: 00390458124950
email: daniele.munari@univr.it
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Universita di Verona
investigator full name: Nicola Smania, MD, Clinical Professor
investigator title: Full Professor
mesh term: Stroke
mesh term: Motor Disorders
sharing ipd: No