<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/NCT03284606</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/15/7839</org_study_id>
    <secondary_id>2016-A01552-49</secondary_id>
    <nct_id>NCT03284606</nct_id>
  </id_info>
  <brief_title>Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers</brief_title>
  <acronym>NEUROTAP</acronym>
  <official_title>A Pilot Study of the Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Groupement Interrégional de Recherche Clinique et d'Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      A majority of people undergoing rehabilitation following a stroke have a deficit of the&#xD;
      dorsal flexors of the foot. The implementation of rehabilitation techniques in accordance&#xD;
      with the recommendations of learned societies is not sufficient to compensate for this&#xD;
      deficit. Also Kinesio Taping's method of Dr. Kenzo Kase has caught our attention by its&#xD;
      action on muscle, joint, circulatory and pain functions.&#xD;
&#xD;
      The use of taping would increase the duration of stimulation of the muscles of the&#xD;
      dorsiflexors of the foot which would facilitate the motor recovery.&#xD;
&#xD;
      Data from the literature do not support the conclusion that taping is effective, but no&#xD;
      studies evaluating the efficacy of this technique in the foot-lift deficiency of the&#xD;
      hemiplegic patient have been found.&#xD;
&#xD;
      The investigators hypothesize that the use of taping in conjunction with common&#xD;
      rehabilitation for hemiplegic patients following a stroke improves the stimulation of the&#xD;
      muscles of the dorsiflexors of the foot with a positive impact on the walking.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment default&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>voluntary muscularity</measure>
    <time_frame>Week 10</time_frame>
    <description>voluntary muscularity measured by the quotation of Held and Pierrot Deseilligny</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spasticity score</measure>
    <time_frame>Week 10</time_frame>
    <description>Ashworth scale modified for spasticity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Hemiplegia</condition>
  <arm_group>
    <arm_group_label>TAPING</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>taping in conjunction with common rehabilitation for hemiplegic patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NO TAPING</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Common rehabilitation for hemiplegic patients without taping</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TAPING</intervention_name>
    <description>Taping in conjunction with common rehabilitation for hemiplegic patients</description>
    <arm_group_label>TAPING</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Common rehabilitation</intervention_name>
    <description>Common rehabilitation for hemiplegic patients</description>
    <arm_group_label>NO TAPING</arm_group_label>
    <arm_group_label>TAPING</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a stroke occurring in a period ranging from 15 days to a month before&#xD;
             inclusion and presenting left or right hemiplegia.&#xD;
&#xD;
          -  Voluntary motricity of the dorsal flexors of the foot greater than or equal to 1 on&#xD;
             the scale of Held and Pierrot Deseilligny&#xD;
&#xD;
          -  Quadriceps voluntary motor skill greater than or equal to 2 on the scale of Held and&#xD;
             Pierrot Deseilligny&#xD;
&#xD;
          -  Informed consent of the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Evolutive neurological disease leading to cognitive impairment (Alzheimer's,&#xD;
             Parkinson's, Multiple sclerosis ...)&#xD;
&#xD;
          -  Pre-stroke neurological sequelae&#xD;
&#xD;
          -  Achilles tendon elongation or tendinous transfer surgery.&#xD;
&#xD;
          -  Spasticity of the sural triceps greater than 2 on the modified Ashworth scale&#xD;
&#xD;
          -  Injection of botulinum toxin&#xD;
&#xD;
          -  Patients under guardianship, curatorships or under safeguard of justice.&#xD;
&#xD;
          -  Allergy to glue, skin lesions located on the zone of laying of the bands&#xD;
&#xD;
          -  Complex Regional Pain Symptom of the Ankle&#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_official>
    <last_name>Aurélie MORIN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31052</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2022</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>Hemiplegia</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/NCT03284606
org study id: RC31/15/7839
secondary id: 2016-A01552-49
nct id: NCT03284606
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A majority of people undergoing rehabilitation following a stroke have a deficit of the
      dorsal flexors of the foot. The implementation of rehabilitation techniques in accordance
      with the recommendations of learned societies is not sufficient to compensate for this
      deficit. Also Kinesio Taping's method of Dr. Kenzo Kase has caught our attention by its
      action on muscle, joint, circulatory and pain functions.

      The use of taping would increase the duration of stimulation of the muscles of the
      dorsiflexors of the foot which would facilitate the motor recovery.

      Data from the literature do not support the conclusion that taping is effective, but no
      studies evaluating the efficacy of this technique in the foot-lift deficiency of the
      hemiplegic patient have been found.

      The investigators hypothesize that the use of taping in conjunction with common
      rehabilitation for hemiplegic patients following a stroke improves the stimulation of the
      muscles of the dorsiflexors of the foot with a positive impact on the walking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: voluntary muscularity
time frame: Week 10
description: voluntary muscularity measured by the quotation of Held and Pierrot Deseilligny
measure: Spasticity score
time frame: Week 10
description: Ashworth scale modified for spasticity
arm group label: TAPING
arm group type: Experimental
description: taping in conjunction with common rehabilitation for hemiplegic patients
arm group label: NO TAPING
arm group type: Placebo Comparator
description: Common rehabilitation for hemiplegic patients without taping
intervention type: Device
intervention name: TAPING
description: Taping in conjunction with common rehabilitation for hemiplegic patients
arm group label: TAPING
intervention type: Procedure
intervention name: Common rehabilitation
description: Common rehabilitation for hemiplegic patients
arm group label: NO TAPING
arm group label: TAPING
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aurélie MORIN
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Hemiplegia
sharing ipd: No