<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/NCT03032692</url>
  </required_header>
  <id_info>
    <org_study_id>RCT-BFK01</org_study_id>
    <nct_id>NCT03032692</nct_id>
  </id_info>
  <brief_title>Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial</brief_title>
  <official_title>Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sword Health, SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CMM - Centro Médico da Murtosa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CMM - Centro Médico de Aveiro</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Médico de Viseu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sword Health, SA</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 study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD&#xD;
      - in the motor performance of patients after stroke. The SWORD system combines inertial&#xD;
      motion trackers and a mobile app, allowing digitization of patient motion and providing&#xD;
      real-time audiovisual biofeedback.&#xD;
&#xD;
      The investigators hypothesize that the biofeedback feedback provided by the SWORD system&#xD;
      improves patient performance, defined as an increase in the number of correct movements.&#xD;
&#xD;
      The design of the study is a cross-over randomized clinical trial. Patients will be&#xD;
      randomized into two groups. Both will perform two separate sessions consisting of one&#xD;
      exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both&#xD;
      experimental settings: with and without biofeedback. Group 1 will perform the exercise with&#xD;
      biofeedback first and without biofeedback after, with an interval &gt;24h. Group 2 will perform&#xD;
      the exercise in the opposite order. The SWORD system will be used to record movement data in&#xD;
      both sessions, but the feedback was only active in one of them.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">August 31, 2016</completion_date>
  <primary_completion_date type="Actual">August 31, 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of correct movements</measure>
    <time_frame>At the end of each exercise session (4 minute duration)</time_frame>
    <description>Number of correct movements performed within the duration of each exercise session</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of repetitions</measure>
    <time_frame>At the end of each exercise session (4 minute duration)</time_frame>
    <description>Total number of repetitions performed within the duration of each exercise session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of incorrect repetitions</measure>
    <time_frame>At the end of each exercise session (4 minute duration)</time_frame>
    <description>Number of incorrect repetitions performed within the duration of each exercise session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of consecutive incorrect repetitions</measure>
    <time_frame>At the end of each exercise session (4 minute duration)</time_frame>
    <description>Number of consecutive incorrect repetitions performed within the duration of each exercise session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of pauses</measure>
    <time_frame>At the end of each exercise session (4 minute duration)</time_frame>
    <description>Number of pauses registered during each exercise session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Posture errors</measure>
    <time_frame>At the end of each exercise session (4 minute duration)</time_frame>
    <description>Number of posture errors registered during each exercise session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Movement frequency</measure>
    <time_frame>At the end of each exercise session (4 minute duration)</time_frame>
    <description>Movement frequency (in Hertz) during each exercise session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion of correct movements</measure>
    <time_frame>At the end of each exercise session (4 minute duration)</time_frame>
    <description>Mean range of motion of the correct movements performed during each exercise session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion variability over time</measure>
    <time_frame>Between the second and first minute; between the second and third minutes; between the third and fourth minute</time_frame>
    <description>Variability of the mean range of motion during the exercise session (for correct movements)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Upper Extremity Paresis</condition>
  <arm_group>
    <arm_group_label>SWORD and exercise with biofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. During the session, SWORD will be providing real-time audiovisual feedback. The patient has to start in the baseline position and fill the progress bar without violating movement or posture constraints. If the patient does not reach the goal or violates constraints he will receive a negative audio feedback, the progress bar will turn red and be reset. The patient has to return to the baseline position to restart the movement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SWORD and exercise without biofeedback</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. The patient will then be instructed to perform as many movements as possible during the allocated time (4 minutes), at a comfortable pace, starting at or below the baseline and trying to reach maximum flexion without significant pain or discomfort. During the session, the SWORD system will be recording the patient´s movement without providing feedback to the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SWORD</intervention_name>
    <description>Both arms will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in two experimental conditions: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after; group 2 performed the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions.</description>
    <arm_group_label>SWORD and exercise with biofeedback</arm_group_label>
    <arm_group_label>SWORD and exercise without biofeedback</arm_group_label>
    <other_name>Stroke Wearable Operative Rehabilitation Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise with biofeedback</intervention_name>
    <arm_group_label>SWORD and exercise with biofeedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise without biofeedback</intervention_name>
    <arm_group_label>SWORD and exercise without biofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical symptoms and signs and CT or MRI findings compatible with a lesion in the&#xD;
             territory of the medial cerebral artery;&#xD;
&#xD;
          -  persistent motor deficit on the upper limb but not plegia with a score between 0 and 2&#xD;
             on item 5b of the National Institute of Health Stroke Scale (NIHSS)&#xD;
&#xD;
          -  more than 2 weeks after stroke onset;&#xD;
&#xD;
          -  the ability to sit comfortably for more than 10 minutes and perform two-step commands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no detectable motor deficits at baseline assessment;&#xD;
&#xD;
          -  severe aphasia;&#xD;
&#xD;
          -  clinical dementia or mini mental state examination (MMSE) below cutoff;&#xD;
&#xD;
          -  other cognitive or psychiatric comorbidity that impaired communication or compliance&#xD;
             with the tasks;&#xD;
&#xD;
          -  severe respiratory or cardiac condition incompatible with more than 5 minutes of&#xD;
             continuous mild exercise in a sitting position;&#xD;
&#xD;
          -  pain or deformity that limited upper limb movement on the affected side.&#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>Fernando D Correia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sword Health, SA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CMM - Murtosa</name>
      <address>
        <city>Murtosa</city>
        <state>Aveiro</state>
        <zip>3870-216</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMM - Centro Médico de Aveiro</name>
      <address>
        <city>Aveiro</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMM- Centro Médico de Viseu</name>
      <address>
        <city>Viseu</city>
        <zip>3500-719</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>June 12, 2017</last_update_submitted>
  <last_update_submitted_qc>June 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2017</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>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Paresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual Participant Data will not be made available to other researchers</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://drive.google.com/file/d/0B2kmuI2zObfcMVhZYWhpdm9fRUE/view?usp=sharing</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03032692
org study id: RCT-BFK01
nct id: NCT03032692
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD
      - in the motor performance of patients after stroke. The SWORD system combines inertial
      motion trackers and a mobile app, allowing digitization of patient motion and providing
      real-time audiovisual biofeedback.

      The investigators hypothesize that the biofeedback feedback provided by the SWORD system
      improves patient performance, defined as an increase in the number of correct movements.

      The design of the study is a cross-over randomized clinical trial. Patients will be
      randomized into two groups. Both will perform two separate sessions consisting of one
      exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both
      experimental settings: with and without biofeedback. Group 1 will perform the exercise with
      biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform
      the exercise in the opposite order. The SWORD system will be used to record movement data in
      both sessions, but the feedback was only active in one of them.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of correct movements
time frame: At the end of each exercise session (4 minute duration)
description: Number of correct movements performed within the duration of each exercise session
measure: Total number of repetitions
time frame: At the end of each exercise session (4 minute duration)
description: Total number of repetitions performed within the duration of each exercise session
measure: Number of incorrect repetitions
time frame: At the end of each exercise session (4 minute duration)
description: Number of incorrect repetitions performed within the duration of each exercise session
measure: Number of consecutive incorrect repetitions
time frame: At the end of each exercise session (4 minute duration)
description: Number of consecutive incorrect repetitions performed within the duration of each exercise session
measure: Number of pauses
time frame: At the end of each exercise session (4 minute duration)
description: Number of pauses registered during each exercise session
measure: Posture errors
time frame: At the end of each exercise session (4 minute duration)
description: Number of posture errors registered during each exercise session
measure: Movement frequency
time frame: At the end of each exercise session (4 minute duration)
description: Movement frequency (in Hertz) during each exercise session
measure: Range of motion of correct movements
time frame: At the end of each exercise session (4 minute duration)
description: Mean range of motion of the correct movements performed during each exercise session
measure: Range of motion variability over time
time frame: Between the second and first minute; between the second and third minutes; between the third and fourth minute
description: Variability of the mean range of motion during the exercise session (for correct movements)
arm group label: SWORD and exercise with biofeedback
arm group type: Experimental
description: The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. During the session, SWORD will be providing real-time audiovisual feedback. The patient has to start in the baseline position and fill the progress bar without violating movement or posture constraints. If the patient does not reach the goal or violates constraints he will receive a negative audio feedback, the progress bar will turn red and be reset. The patient has to return to the baseline position to restart the movement.
arm group label: SWORD and exercise without biofeedback
arm group type: Active Comparator
description: The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. The patient will then be instructed to perform as many movements as possible during the allocated time (4 minutes), at a comfortable pace, starting at or below the baseline and trying to reach maximum flexion without significant pain or discomfort. During the session, the SWORD system will be recording the patient´s movement without providing feedback to the patient.
intervention type: Device
intervention name: SWORD
description: Both arms will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in two experimental conditions: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after; group 2 performed the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions.
arm group label: SWORD and exercise with biofeedback
arm group label: SWORD and exercise without biofeedback
other name: Stroke Wearable Operative Rehabilitation Device
intervention type: Other
intervention name: Exercise with biofeedback
arm group label: SWORD and exercise with biofeedback
intervention type: Other
intervention name: exercise without biofeedback
arm group label: SWORD and exercise without biofeedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fernando D Correia, MD
role: Principal Investigator
affiliation: Sword Health, SA
facility: 
facility: 
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Paresis
sharing ipd: No
ipd description: Individual Participant Data will not be made available to other researchers
study doc: 