<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/NCT04464863</url>
  </required_header>
  <id_info>
    <org_study_id>KAM-Study (PI-3787)</org_study_id>
    <nct_id>NCT04464863</nct_id>
  </id_info>
  <brief_title>Kinematic Analysis in Stroke Patients Using Microsoft Kinect and Akira Software: Kinect-Akira Movement Study</brief_title>
  <acronym>KAM</acronym>
  <official_title>Kinematic Analysis in Stroke Patients Using Microsoft Kinect and Akira Software: Kinect-Akira Movement Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigación Hospital Universitario La Paz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Investigación Hospital Universitario La Paz</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>
      In this prospective, unicentric, case-control study, the main aim is to analyze joint&#xD;
      movement and walking patterns in patients with acute stroke with a marker-free motion capture&#xD;
      system. Case group: Stroke patients who fulfill the inclusion criteria are invited to&#xD;
      participate in the study during admission. The evaluation consists of a workout designed by&#xD;
      expert rehabilitation physicians and neurologists that is performed by the patient in front&#xD;
      of the Microsoft Kinect camera. The custom-built software Akira record the joint angles of&#xD;
      body trunk and upper limbs during the workout. The kinematic data will be analyzed with a&#xD;
      machine learning algorithm that classifies the participant according to the kinematic data in&#xD;
      normal movement or impaired movement (with the degree of impairment) by age decade. Control&#xD;
      group: healthy participants (without neurological or osteomuscular diseases) matched by age&#xD;
      and sex with cases 1:1. The correlation between kinematic and clinical scales (NIHSS) and&#xD;
      functional scales (modified Rankin Scale) will be analyzed. A secondary objective will be to&#xD;
      analyze the predictive value of the kinematic measurements with the functional outcome at&#xD;
      three months&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 29, 2020</start_date>
  <completion_date type="Anticipated">June 29, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 29, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Kinematic metrics: join angles</measure>
    <time_frame>The change between the first week of index stroke (acute phase) and at 3 months after index stroke</time_frame>
    <description>The kinect camera together with the software Akira will be used to automatically measure the degree angle of the following body joints: shoulder in abduction, shoulder inflexion, elbow in extension and in flexion and the angle formed by the forearm and the trunk with the shoulder in abduction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic metrics: movement acceleration</measure>
    <time_frame>The change between the first week of index stroke (acute phase) and at 3 months after index stroke</time_frame>
    <description>The kinect camera together with the software Akira will be used to automatically measure the acceleration of the following movements: shoulder abduction and shoulder flexion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic metrics: movement pattern</measure>
    <time_frame>The change between the first week of index stroke (acute phase) and at 3 months after index stroke</time_frame>
    <description>The kinect camera together with the software Akira will be used to automatically measure the pattern of the following movements: trunk oscillation during standing position and during walking; and trunk oscillation during seating position with opened and closed eyes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship of kinematic measures with the degree of disability after stroke.</measure>
    <time_frame>At 3 months after the index stroke</time_frame>
    <description>Correlation between the kinematic metrics described before (joint angles, movement acceleration and movement pattern) and the degree of disability, measured y the modified Rankin scale. The modified Rankin Scale (mRS) is a extensively use scale to measure dependency after stroke. The minimum value is 0 (no sequels or disability) and the maximum value is 6 (dead). The lower the score in the scale, the better is the outcome.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Acute stroke patients during the first week of evolution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Age and sex 1:1 healthy participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinematic metrics</intervention_name>
    <description>kinematic metrics recorded with Kinect (register brand) and extracted with Akira (register brand)</description>
    <arm_group_label>Cases</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute stroke patients and healthy controls, matched by age and sex. The inclusion and&#xD;
        exclusion criteria are defined below&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute Stroke patients (within the first week of index stroke)&#xD;
&#xD;
          -  Neurological deficit present at the moment of the evaluation.&#xD;
&#xD;
          -  Informed consent signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical instability&#xD;
&#xD;
          -  Aphasia or cognitive decline that prevents the understanding of the workout.&#xD;
&#xD;
          -  Refuse to participate&#xD;
&#xD;
          -  Previous neurological or osteomuscular conditions.&#xD;
&#xD;
          -  Previous conditions with less than 3 months of expectancy of life.&#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>María Alonso de Leciñana, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Universitario La Paz, IdiPAZ</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>María Alonso de Leciñana, MD PhD</last_name>
    <phone>+34 917 277 444</phone>
    <email>malecinanacases@salud.madrid.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Raquel Gutiérrez Zúñiga, MD</last_name>
    <phone>+34 917 277 444</phone>
    <email>rgutierrezz@salud.madrid.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>La Paz University Hospital, IdiPAZ</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Exuperio Díez Tejedor, MD, PhD, Prof.</last_name>
      <phone>917277444</phone>
      <phone_ext>+34</phone_ext>
      <email>exuperio-diez@salud.madrid.org</email>
    </contact>
    <contact_backup>
      <last_name>Raquel Gutiérrez Zúñiga, MD</last_name>
      <phone>917277444</phone>
      <phone_ext>+34</phone_ext>
      <email>rgutierrezz@salud.madrid.org</email>
    </contact_backup>
    <investigator>
      <last_name>Blanca Fuentes Gimeno</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>María Alonso de Leciñana</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elena de Celis Ruiz</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Raquel Gutiérrez Zúñiga</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Silvia Pastor Yvorra</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ricardo Riguel Bobillo</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gerardo Ruiz Ares</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jorge Rodríguez Pardo</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Begoña Marín</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lucía Millet</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Exuperio Díez Tejedor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Hernández</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
  </intervention_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/NCT04464863
org study id: KAM-Study (PI-3787)
nct id: NCT04464863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this prospective, unicentric, case-control study, the main aim is to analyze joint
      movement and walking patterns in patients with acute stroke with a marker-free motion capture
      system. Case group: Stroke patients who fulfill the inclusion criteria are invited to
      participate in the study during admission. The evaluation consists of a workout designed by
      expert rehabilitation physicians and neurologists that is performed by the patient in front
      of the Microsoft Kinect camera. The custom-built software Akira record the joint angles of
      body trunk and upper limbs during the workout. The kinematic data will be analyzed with a
      machine learning algorithm that classifies the participant according to the kinematic data in
      normal movement or impaired movement (with the degree of impairment) by age decade. Control
      group: healthy participants (without neurological or osteomuscular diseases) matched by age
      and sex with cases 1:1. The correlation between kinematic and clinical scales (NIHSS) and
      functional scales (modified Rankin Scale) will be analyzed. A secondary objective will be to
      analyze the predictive value of the kinematic measurements with the functional outcome at
      three months
observational model: Case-Control
time perspective: Prospective
measure: Kinematic metrics: join angles
time frame: The change between the first week of index stroke (acute phase) and at 3 months after index stroke
description: The kinect camera together with the software Akira will be used to automatically measure the degree angle of the following body joints: shoulder in abduction, shoulder inflexion, elbow in extension and in flexion and the angle formed by the forearm and the trunk with the shoulder in abduction.
measure: Kinematic metrics: movement acceleration
time frame: The change between the first week of index stroke (acute phase) and at 3 months after index stroke
description: The kinect camera together with the software Akira will be used to automatically measure the acceleration of the following movements: shoulder abduction and shoulder flexion.
measure: Kinematic metrics: movement pattern
time frame: The change between the first week of index stroke (acute phase) and at 3 months after index stroke
description: The kinect camera together with the software Akira will be used to automatically measure the pattern of the following movements: trunk oscillation during standing position and during walking; and trunk oscillation during seating position with opened and closed eyes.
measure: Relationship of kinematic measures with the degree of disability after stroke.
time frame: At 3 months after the index stroke
description: Correlation between the kinematic metrics described before (joint angles, movement acceleration and movement pattern) and the degree of disability, measured y the modified Rankin scale. The modified Rankin Scale (mRS) is a extensively use scale to measure dependency after stroke. The minimum value is 0 (no sequels or disability) and the maximum value is 6 (dead). The lower the score in the scale, the better is the outcome.
arm group label: Cases
description: Acute stroke patients during the first week of evolution
arm group label: Control
description: Age and sex 1:1 healthy participants
intervention type: Other
intervention name: Kinematic metrics
description: kinematic metrics recorded with Kinect (register brand) and extracted with Akira (register brand)
arm group label: Cases
arm group label: Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: María Alonso de Leciñana, MD PhD
role: Study Director
affiliation: Hospital Universitario La Paz, IdiPAZ
last name: María Alonso de Leciñana, MD PhD
phone: +34 917 277 444
email: malecinanacases@salud.madrid.org
last name: Raquel Gutiérrez Zúñiga, MD
phone: +34 917 277 444
email: rgutierrezz@salud.madrid.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Stroke
mesh term: Metronidazole