<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/NCT04502927</url>
  </required_header>
  <id_info>
    <org_study_id>GHR 1020</org_study_id>
    <secondary_id>IDRCB 2019-A02953-54</secondary_id>
    <nct_id>NCT04502927</nct_id>
  </id_info>
  <brief_title>Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients</brief_title>
  <acronym>PHYSIOHAND</acronym>
  <official_title>Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier de la Region de Mulhouse et Sud Alsace</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Hospitalier de la Region de Mulhouse et Sud Alsace</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>
      The main objective of this monocentric prospective study is to evaluate the amplitudes and&#xD;
      angular velocities of extension of the hand and wrist joints during passive mobilization by a&#xD;
      physiotherapist in healthy subjects and stroke patients with spastic hands.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  To compare amplitude and angular velocity values between the group of stroke patients&#xD;
           and the group of healthy volunteers,&#xD;
&#xD;
        -  To compare amplitude and angular velocity values according to the two types of&#xD;
           mobilization (i,e, thumb or fifth finger),&#xD;
&#xD;
        -  To assess pain due to mobilization in stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conduct of research:&#xD;
&#xD;
      The realization of the measures will take place at the GHRMSA rehabilitation department.&#xD;
&#xD;
      After receiving the written consent of the study participant, the physiotherapist will&#xD;
      proceed with the passive mobilization of the spastic hand of the stroke patient or the&#xD;
      dominant hand for healthy volunteers. Videos of the hand will be made using the Darfish&#xD;
      system which will allow analysis of the primary endpoint.&#xD;
&#xD;
      Two mobilizations will be performed for each participant, i.e. one for each type of medial or&#xD;
      lateral grip. The order of mobilization will be determined by randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitement issues related to COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Actual">March 18, 2020</completion_date>
  <primary_completion_date type="Actual">March 18, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amplitude values</measure>
    <time_frame>1 minute after intervention</time_frame>
    <description>Amplitude values will be calculated with the Dartfish® system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Angular velocity values</measure>
    <time_frame>1 minute after intervention</time_frame>
    <description>Angular velocity values will be calculated with the Dartfish® system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean amplitude of the two groups</measure>
    <time_frame>1 minute after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean angular velocity of the two groups</measure>
    <time_frame>1 minute after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean amplitude after mobilization with thumb abduction</measure>
    <time_frame>1 minute after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean angular velocity after mobilization with thumb abduction</measure>
    <time_frame>1 minute after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean amplitude after mobilization of the fifth finger</measure>
    <time_frame>1 minute after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean angular velocity after mobilization of the fifth finger</measure>
    <time_frame>1 minute after intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain experienced by stroke patients before mobilisation</measure>
    <time_frame>1 minute before intervention</time_frame>
    <description>Pain will be assessed by the Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain experienced by stroke patients after mobilisation</measure>
    <time_frame>1 minute after intervention</time_frame>
    <description>Pain will be assessed by the Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Muscle Spasticity</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Stroke patients with hand spasticity (n=20)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers (n=10)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Passive extension mobilization of the hand and wrist joints</intervention_name>
    <description>The physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers.&#xD;
Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.</description>
    <arm_group_label>Healthy volunteers (n=10)</arm_group_label>
    <arm_group_label>Stroke patients with hand spasticity (n=20)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility criteria of stroke patients with hand spasticity:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  First stroke diagnosed less than 3 months ago&#xD;
&#xD;
          -  Non-functional wrist defined by the Fugl-Meyer Assesment (FMA-EU) upper limb motor&#xD;
             subscale with a score ≤45&#xD;
&#xD;
          -  Wrist flexor spasticity defined by the Modified Tardieu Scale (MTS) with a rating ≥1&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
&#xD;
        Eligibility criteria of healthy volunteers:&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas Winisdoerffer</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHRMSA hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier de la Région de Mulhouse et Sud Alsace</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>July 7, 2021</last_update_submitted>
  <last_update_submitted_qc>July 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Muscle Spasticity</keyword>
  <keyword>Mobilization</keyword>
  <keyword>Wrist and Hand Complex</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <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/NCT04502927
org study id: GHR 1020
secondary id: IDRCB 2019-A02953-54
nct id: NCT04502927
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this monocentric prospective study is to evaluate the amplitudes and
      angular velocities of extension of the hand and wrist joints during passive mobilization by a
      physiotherapist in healthy subjects and stroke patients with spastic hands.

      Secondary objectives:

        -  To compare amplitude and angular velocity values between the group of stroke patients
           and the group of healthy volunteers,

        -  To compare amplitude and angular velocity values according to the two types of
           mobilization (i,e, thumb or fifth finger),

        -  To assess pain due to mobilization in stroke patients.
Conduct of research:

      The realization of the measures will take place at the GHRMSA rehabilitation department.

      After receiving the written consent of the study participant, the physiotherapist will
      proceed with the passive mobilization of the spastic hand of the stroke patient or the
      dominant hand for healthy volunteers. Videos of the hand will be made using the Darfish
      system which will allow analysis of the primary endpoint.

      Two mobilizations will be performed for each participant, i.e. one for each type of medial or
      lateral grip. The order of mobilization will be determined by randomization.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Amplitude values
time frame: 1 minute after intervention
description: Amplitude values will be calculated with the Dartfish® system
measure: Angular velocity values
time frame: 1 minute after intervention
description: Angular velocity values will be calculated with the Dartfish® system
measure: Mean amplitude of the two groups
time frame: 1 minute after intervention
measure: Mean angular velocity of the two groups
time frame: 1 minute after intervention
measure: Mean amplitude after mobilization with thumb abduction
time frame: 1 minute after intervention
measure: Mean angular velocity after mobilization with thumb abduction
time frame: 1 minute after intervention
measure: Mean amplitude after mobilization of the fifth finger
time frame: 1 minute after intervention
measure: Mean angular velocity after mobilization of the fifth finger
time frame: 1 minute after intervention
measure: Pain experienced by stroke patients before mobilisation
time frame: 1 minute before intervention
description: Pain will be assessed by the Visual Analogue Scale (VAS)
measure: Pain experienced by stroke patients after mobilisation
time frame: 1 minute after intervention
description: Pain will be assessed by the Visual Analogue Scale (VAS)
arm group label: Stroke patients with hand spasticity (n=20)
arm group type: Other
arm group label: Healthy volunteers (n=10)
arm group type: Other
intervention type: Procedure
intervention name: Passive extension mobilization of the hand and wrist joints
description: The physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers.
Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.
arm group label: Healthy volunteers (n=10)
arm group label: Stroke patients with hand spasticity (n=20)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nicolas Winisdoerffer
role: Principal Investigator
affiliation: GHRMSA hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Stroke
sharing ipd: No