<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/NCT03754166</url>
  </required_header>
  <id_info>
    <org_study_id>RC18_0288</org_study_id>
    <nct_id>NCT03754166</nct_id>
  </id_info>
  <brief_title>Feasibility of Constraint-induced Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke</brief_title>
  <acronym>ITHEMICAL</acronym>
  <official_title>Feasibility of Modified Constraint-induced Movement Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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 aim of this study is to test the feasibility of a constraint intervention combined with&#xD;
      visual-spatial cueing strategy in patients with acute stroke to improve their daily life&#xD;
      activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As part of treatment in acute stroke (from D0 to D14), the investigators were able to observe&#xD;
      that despite motor recovery during physiotherapy sessions, it remained difficult for some&#xD;
      patients to use their affected arm (AA) during activities of daily life (ADL). This mechanism&#xD;
      of &quot;learned non-use&quot; would be due to a cognitive process decreasing the use of the AA and&#xD;
      could partly explain that 75% of patients maintain an upper limb deficit at 3-6 month&#xD;
      post-stroke.&#xD;
&#xD;
      In order to combat this phenomenon, a bottom up method (sensorimotor action on the deficit)&#xD;
      of constraint-induced movement therapy (CIMT) has been developed and consists in immobilizing&#xD;
      the unaffected arm to force the use of the AA.&#xD;
&#xD;
      This technique has proved its effectiveness in the chronic phase and has also recently been&#xD;
      proven to improve motor performance in the acute phase. Transposing progress on ADL, however,&#xD;
      remains difficult because CIMT does not contain adequate behavioral strategies.&#xD;
&#xD;
      To help the patient mobilize these strategies, coupling of CIMT with a top-down method&#xD;
      (conscious action on motor skills) has been successfully tested as an intervention of an&#xD;
      occupational therapist with the patient at least 1h / day. This intervention remains not&#xD;
      compatible with the investigators care organization because the caregiver can not spend that&#xD;
      amount of time with each patient.&#xD;
&#xD;
      Investigators therefore propose to associate CIMT with another top down technique:&#xD;
      visual-spatial cueing (use of panels and/or visual messages to encourage the conscious use of&#xD;
      the AA) and investigators want to evaluate the effectiveness of this treatment on learning&#xD;
      transfer to ADL.&#xD;
&#xD;
      The objective of our study will be to test the feasibility of setting up such an&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study non feasible following changes in organisation of service&#xD;
  </why_stopped>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Actual">February 12, 2020</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</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>Number of tasks realized per protocol between the two arms</measure>
    <time_frame>Day 15</time_frame>
    <description>Variances to a predetermined checklist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arm motor function</measure>
    <time_frame>Day 0, Day 15 and Month 3</time_frame>
    <description>Action Research Arm Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain evolution</measure>
    <time_frame>Day 0, Day 7, Day 15 and Month 3</time_frame>
    <description>Use of Visual analogue scale to determine the degree of pain on a scale from 0 to 10 (0: meaning no pain, 10 being maximal tolerable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression evolution</measure>
    <time_frame>Day 0, Day 7, Day 15 and Month 3</time_frame>
    <description>Use of Hospital Anxiety and Depression Scale. This scale has 14 items in total, 7 items for Anxiety and 7 for Depression. Each item is rated from 0 to 3. score of 0 meaning normal, score 3 meaning abnormal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Situation of patient after neurovascular unit</measure>
    <time_frame>Month 3</time_frame>
    <description>Indication of patient 's situation at the end of the study: either Rehabilitation center, Nursing homes, Home or Other</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Acute Stroke</condition>
  <arm_group>
    <arm_group_label>Constraint-induced movement therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient's unaffected arm is restrained, by a glove including thumb, during activities of daily life (bathing, grooming, dressing and feeding = approx. 4h/day).&#xD;
Visual spatial cueing is displayed in the bedroom and the bathroom.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care of the neurovascular unit. = No constraint, no cueing, and same physiotherapy intervention as experimental arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Constraint-induced movement therapy</intervention_name>
    <description>Patient's unaffected arm is restrained, by a glove including thumb, during activities of daily life (bathing, grooming, dressing and feeding = approx. 4h/day).&#xD;
Visual spatial cueing is displayed in the bedroom and the bathroom.</description>
    <arm_group_label>Constraint-induced movement therapy</arm_group_label>
    <other_name>Visual-spatial cueing : top down</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patient in neurovascular unit for stroke&#xD;
&#xD;
          -  Time since stroke between 2 and 4 days&#xD;
&#xD;
          -  Movement capacity of the upper arm (against gravity) :&#xD;
&#xD;
          -  Ability to extend actively the metacarpophalangeal and interphalangeal joints at least&#xD;
             10°, and the wrist 20°&#xD;
&#xD;
          -  Ability to bend actively the elbow at least 45°&#xD;
&#xD;
          -  Ability to bend and abduct actively the shoulder at least ≥ 45°&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Patient agreement to join the study&#xD;
&#xD;
          -  Patient covered by french social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Excessive spasticity : score &gt; 2 on the modified Ashworth scale&#xD;
&#xD;
          -  Excessive pain in the affected arm : score ≥ 4 on the visual analogue scale&#xD;
&#xD;
          -  Joint limitation on the affected arm&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#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>Ambre Komonski</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nantes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Neurologie, CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>December 14, 2020</last_update_submitted>
  <last_update_submitted_qc>December 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 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>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT03754166
org study id: RC18_0288
nct id: NCT03754166
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to test the feasibility of a constraint intervention combined with
      visual-spatial cueing strategy in patients with acute stroke to improve their daily life
      activities.
As part of treatment in acute stroke (from D0 to D14), the investigators were able to observe
      that despite motor recovery during physiotherapy sessions, it remained difficult for some
      patients to use their affected arm (AA) during activities of daily life (ADL). This mechanism
      of "learned non-use" would be due to a cognitive process decreasing the use of the AA and
      could partly explain that 75% of patients maintain an upper limb deficit at 3-6 month
      post-stroke.

      In order to combat this phenomenon, a bottom up method (sensorimotor action on the deficit)
      of constraint-induced movement therapy (CIMT) has been developed and consists in immobilizing
      the unaffected arm to force the use of the AA.

      This technique has proved its effectiveness in the chronic phase and has also recently been
      proven to improve motor performance in the acute phase. Transposing progress on ADL, however,
      remains difficult because CIMT does not contain adequate behavioral strategies.

      To help the patient mobilize these strategies, coupling of CIMT with a top-down method
      (conscious action on motor skills) has been successfully tested as an intervention of an
      occupational therapist with the patient at least 1h / day. This intervention remains not
      compatible with the investigators care organization because the caregiver can not spend that
      amount of time with each patient.

      Investigators therefore propose to associate CIMT with another top down technique:
      visual-spatial cueing (use of panels and/or visual messages to encourage the conscious use of
      the AA) and investigators want to evaluate the effectiveness of this treatment on learning
      transfer to ADL.

      The objective of our study will be to test the feasibility of setting up such an
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of tasks realized per protocol between the two arms
time frame: Day 15
description: Variances to a predetermined checklist
measure: Arm motor function
time frame: Day 0, Day 15 and Month 3
description: Action Research Arm Test
measure: Pain evolution
time frame: Day 0, Day 7, Day 15 and Month 3
description: Use of Visual analogue scale to determine the degree of pain on a scale from 0 to 10 (0: meaning no pain, 10 being maximal tolerable pain)
measure: Anxiety and Depression evolution
time frame: Day 0, Day 7, Day 15 and Month 3
description: Use of Hospital Anxiety and Depression Scale. This scale has 14 items in total, 7 items for Anxiety and 7 for Depression. Each item is rated from 0 to 3. score of 0 meaning normal, score 3 meaning abnormal.
measure: Situation of patient after neurovascular unit
time frame: Month 3
description: Indication of patient 's situation at the end of the study: either Rehabilitation center, Nursing homes, Home or Other
arm group label: Constraint-induced movement therapy
arm group type: Experimental
description: Patient's unaffected arm is restrained, by a glove including thumb, during activities of daily life (bathing, grooming, dressing and feeding = approx. 4h/day).
Visual spatial cueing is displayed in the bedroom and the bathroom.
arm group label: Usual care
arm group type: No Intervention
description: Usual care of the neurovascular unit. = No constraint, no cueing, and same physiotherapy intervention as experimental arm.
intervention type: Other
intervention name: Constraint-induced movement therapy
description: Patient's unaffected arm is restrained, by a glove including thumb, during activities of daily life (bathing, grooming, dressing and feeding = approx. 4h/day).
Visual spatial cueing is displayed in the bedroom and the bathroom.
arm group label: Constraint-induced movement therapy
other name: Visual-spatial cueing : top down
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ambre Komonski
role: Principal Investigator
affiliation: CHU Nantes
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke