<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/NCT02192125</url>
  </required_header>
  <id_info>
    <org_study_id>2014-061</org_study_id>
    <nct_id>NCT02192125</nct_id>
  </id_info>
  <brief_title>REWIRE - Rehabilitative Wayout In Responsive Home Environments, A Pilot Trial</brief_title>
  <acronym>REWIRE</acronym>
  <official_title>Phase 1 REWIRE - Rehabilitative Wayout In Responsive Home Environments, A Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ecole Polytechnique Fédérale de Lausanne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ab.Acus Srl</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundación Pública Andaluza Progreso y Salud</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technogym SpA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundació Privada Barcelona Digital Centre Tecnològic (BDIGITAL)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Zürich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>JSI Research &amp; Training Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospitales Universitarios Virgen del Rocío</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study examines the possible application of the rehabilitation platform REWIRE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The REWIRE rehabilitation platform consists of three hierarchical components: the &quot;Patient&#xD;
      Station&quot; (PS), which is installed in the home environment of the patient; the &quot;Hospital&#xD;
      Station&quot; (HS), which allows an exchange of information with more horsepower and is served by&#xD;
      the therapists in the hospital; and the &quot;Networking Station&quot; (NS), which allows a combination&#xD;
      of a plurality of HS.&#xD;
&#xD;
      The PS consists of a standard laptop with a specifically created for the rehabilitation&#xD;
      REWIRE platform and pre-installed software (Università degli Studi di Milano, Italy, Applied&#xD;
      Intelligent Systems Laboratory Department of Computer Science). In the context of a training&#xD;
      system connected to the computer, the software enables the collection of data, which are&#xD;
      recorded as part of the training. In this study only exercises for balance ability are part&#xD;
      of the training program. The training system consists of a so-called Tymoplate® (Tyromotion,&#xD;
      Austria), a medical device class 1 with CE certification and approval by the FDA for use in&#xD;
      neurorehabilitation after stroke. The Tymoplate® is connected to the computer and allows by&#xD;
      means of a base plate with integrated pressure sensors and custom-developed training&#xD;
      software, various postural biofeedback exercises. In combination with 3D cameras (Kinect®,&#xD;
      PrimeSense, CA, USA), the patient sees him-/herself or an avatar in real time on a screen&#xD;
      which moves in the virtual training environment. By various, attractive and entertaining&#xD;
      designed training games as well as provided audio-visual feedback and balanced score system,&#xD;
      patients should be maximum motivated to exercise.&#xD;
&#xD;
      The HS enables the interaction between patient and therapist and essentially consists of a&#xD;
      MySQL database with web-based interface. The data collected on each PS can be retrieved from&#xD;
      the HS and can be used by therapists in order to set up the training program on the PS to&#xD;
      control and to adjust the difficulty level of the exercises to the individual performance of&#xD;
      each patient.&#xD;
&#xD;
      The NS also consists of a database. It links collected training data and the associated&#xD;
      epidemiological data of different HS at the regional level (potentially also between&#xD;
      different health institutions) to identify on the application of statistical algorithms&#xD;
      general models for the description of relaxation processes in rehabilitation medicine.&#xD;
&#xD;
      In this simple way a frequent and intensive training is without direct therapeutic help in&#xD;
      the home setting at low cost possible. By attractive and entertaining designed training games&#xD;
      as well as interaction and feedback by the therapist, patients are motivated to train each&#xD;
      day with the system and to continually improve in the games. The supervision of the training&#xD;
      by the therapist with the rehabilitation platform REWIRE additionally serves to recognize&#xD;
      improvements of the individual performance or problems and to adapt the difficulty level of&#xD;
      the exercises.&#xD;
&#xD;
      For Patient Registries&#xD;
&#xD;
        -  Patient recruitment Suitable stationed patients at Cereneo in Vitznau will be informed&#xD;
           about the possibility of participation in the study. If interested, the patients will&#xD;
           receive the patient information and can decide within a week whether they will&#xD;
           participate in the study.&#xD;
&#xD;
        -  Data collection We will collect data on daily usage of the patient as well as hospital&#xD;
           stations. Patient usage will be regressed on the patient's deficit severity, age and&#xD;
           gender to gather preliminary knowledge on whether certain subgroups of patients accept&#xD;
           the system better than others.&#xD;
&#xD;
      System usability During and after the pilot trial all involved physicians and physical&#xD;
      therapists will answer a standardised questionnaire on system usability. Specifically we will&#xD;
      look at the number of instructions and therapy modifications given to the patient and whether&#xD;
      the therapist giving the instruction thinks that the patient has reacted accordingly. REWIRE&#xD;
      will be also evaluated, in terms of usability of software instruments, degree of control of&#xD;
      the rehabilitation process and value of the results reported by REWIRE.&#xD;
&#xD;
      - Data management The investigators will use paper case report forms (CRF), one for each&#xD;
      enrolled study participant, to be filled in with all relevant data pertaining to the subject&#xD;
      during the study. The investigator will document the participation of each study subject on&#xD;
      the enrolment log.&#xD;
&#xD;
      All requested information in the CRF should be completed in a neat legible manner. Use of a&#xD;
      black ball pen is recommended to ensure clarity of reproduced copies in the CRF. All&#xD;
      corrections in a paper CRF must be made in a way that does not obscure the original entry.&#xD;
      The correct data must be inserted, dated and initialled by the investigator Data that are not&#xD;
      available or not done should be made clear by adding NA or ND. A declaration ensuring&#xD;
      accuracy of data recorded in the case report forms must be signed by the investigator.&#xD;
&#xD;
      CRFs will be kept current to reflect subject status at each phase during the course of study.&#xD;
      Subjects will not to be identified in the CRF by name. Appropriate coded identification (e.g.&#xD;
      subject number) will be used.&#xD;
&#xD;
      It will be assured that any authorised person, who may perform data entries and changes in&#xD;
      the CRF, can be identified. A list with signatures and initials of all authorised persons&#xD;
      will be filed in the study site file and the trial master file, respectively.&#xD;
&#xD;
      Documented medical histories and narrative statements relative to the subject's progress&#xD;
      during the study will be maintained. These records will also include the following: originals&#xD;
      or copies of laboratory and other medical test results which must be kept on file with the&#xD;
      individual subject's CRF.&#xD;
&#xD;
      The CIP will specify what will be maintained for each subject. The investigators assure to&#xD;
      perform a complete and accurate documentation of the subject data in the CRF. All data&#xD;
      entered into the CRF with exception of (for which data the CRF will be source data to be&#xD;
      specified for each study) must also be available in the individual subject file either as&#xD;
      print-outs or as notes taken by either the investigator or another responsible person&#xD;
      assigned by the investigator.&#xD;
&#xD;
      Data which is not included in the CRF will be stored in a secured access database.&#xD;
&#xD;
      Essential documents must be retained for at least 10 years after the regular end or a&#xD;
      premature termination of the respective study (VKlin Art. 25). Essential documents will be&#xD;
      retained according to local law in case of international multicentre studies.&#xD;
&#xD;
      Any patient files and source data must be archived for the longest possible period of time&#xD;
      according to the feasibility of the investigational site, institution or private practice.&#xD;
&#xD;
        -  Reporting for adverse events Adverse events will be reported to the Ethics Committee&#xD;
           northwest/ central Switzerland EKNZ.&#xD;
&#xD;
        -  Change management Sample size assessment to specify the number of participants or&#xD;
           participant years necessary to demonstrate an effect Number of patients: 15 stroke&#xD;
           patients. Due to the likely large heterogeneity of the study population (different&#xD;
           weights severity of paresis and ataxia, as well as partly cognitive deficits) a&#xD;
           sufficiently large number of patients must be tested. Currently, there are no data which&#xD;
           would allow a power analysis with respect to the primary or secondary end point. In case&#xD;
           of premature withdrawl from the study, those participants will be replaced so that at&#xD;
           least 16 participants carry out the 3-month training program completely.&#xD;
&#xD;
      Plan for missing data to address situations where variables are reported as missing,&#xD;
      unavailable, &quot;non-reported,&quot; uninterpretable, or considered missing because of data&#xD;
      inconsistency or out-of-range results If in individual clinical tests the data is missing,&#xD;
      the concerning test cannot be analysed and will not be considered.&#xD;
&#xD;
      Statistical analysis plan describing the analytical principles and statistical techniques to&#xD;
      be employed in order to address the primary and secondary objectives, as specified in the&#xD;
      study protocol or plan Primarily, the feasibility of the technical and practical&#xD;
      implementation of the rehabilitation REWIRE platform will be evaluated in the&#xD;
      home-environment of the study participants. Furthermore, the satisfaction and patient&#xD;
      compliance and acceptance of the system by the attending physicians and therapists will be&#xD;
      measured. Therefore, structured-standardized questionnaires are used and the quality (if&#xD;
      numerically tangible) will be evaluated by means of Likert scales. Secondary, the effects to&#xD;
      use the training system on the functional recovery and quality of life as well as on the&#xD;
      structural plasticity of the brain will be evaluated. In terms of functional recovery and&#xD;
      quality of life correlation analyses will be performed. Related data from stroke patients&#xD;
      (from the stroke registry ZORRO, KEK-ZH-E-08/2009) will be compared with those from the&#xD;
      REWIRE-study. The evaluation of the data measured by means of magnetic resonance imaging,&#xD;
      require before carrying out a correlation analysis the application of parametric statistical&#xD;
      methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proof of concept</measure>
    <time_frame>week 12</time_frame>
    <description>Technical and practical implementation of the rehabilitation platform REWIRE will be evaluated, by a questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>week 12</time_frame>
    <description>Assessments, change from Baseline :&#xD;
Stroke Impact Scale&#xD;
EuroQol&#xD;
FES-I (Erfassung der sturzassoziierten Selbstwirksamkeit, 10 min)&#xD;
Technology Acceptance Model / TAM</description>
  </secondary_outcome>
  <other_outcome>
    <measure>functional recovery</measure>
    <time_frame>week 12</time_frame>
    <description>Assessment, change from Baseline:&#xD;
fMRI</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>REWIRE-System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The training system consists of a so-called Tymoplate® (Tyromotion, Austria), a medical device class 1 with CE certification and approval by the FDA for use in neurorehabilitation after stroke. The Tymoplate® is connected to a computer and allows by means of a base plate with integrated pressure sensors and custom-developed training software different postural biofeedback exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>REWIRE-System</intervention_name>
    <description>The REWIRE rehabilitation platform consists of three hierarchical components:&#xD;
&quot;patient station&quot; (PS), which is installed in the home environment of the patient:&#xD;
Includes:&#xD;
Laptop with software - Game Tymoplate® - balanceboard Kinect® - 3D tracking&#xD;
&quot;Hospital Station&quot; (HS), which allows an exchange of information with more &quot;patient station&quot; and is served by the therapists in the hospital;&#xD;
Includes:&#xD;
Laptop MySQL- database&#xD;
&quot;station networking&quot; (NS), which allows a combination of a several of HS. database</description>
    <arm_group_label>REWIRE-System</arm_group_label>
    <other_name>Tymoplate®</other_name>
    <other_name>Kinect®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  First-time ischemic stroke&#xD;
&#xD;
          -  Moderate, residual motor deficits of the lower extremity (FAC&gt; 3, 6-min walk ≥ 200 m;&#xD;
             Berg Balance Scale 21-52)&#xD;
&#xD;
          -  Ability and willing to participate in the study&#xD;
&#xD;
          -  signed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other neurological disorders (eg Parkinson's disease, dementia, multiple sclerosis,&#xD;
             peripheral nerve damage, etc.)&#xD;
&#xD;
          -  Moderate to severe aphasia&#xD;
&#xD;
          -  moderate to severe unilateral neglect&#xD;
&#xD;
          -  Severe dementia, MMSE ≤ 20 points&#xD;
&#xD;
          -  Severe depression or psychiatric disorders&#xD;
&#xD;
          -  Other serious diseases, such as severe kidney or liver dysfunction, or serious&#xD;
             dysfunction of the cardiovascular system&#xD;
&#xD;
          -  Relevant loss of vision that can not be compensated by aids, eg Hemianopia, visual&#xD;
             acuity ≤ 20%&#xD;
&#xD;
          -  Severe pain,&gt; 6 points on the visual analog scale&#xD;
&#xD;
          -  Pregnancy&#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>Andrea R Luft, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cerneo</name>
      <address>
        <city>Vitznau</city>
        <state>Luzern</state>
        <zip>6354</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>May 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>September 14, 2015</last_update_submitted>
  <last_update_submitted_qc>September 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>balance</keyword>
  <keyword>training</keyword>
  <keyword>posture</keyword>
  <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/NCT02192125
org study id: 2014-061
nct id: NCT02192125
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The study examines the possible application of the rehabilitation platform REWIRE.
The REWIRE rehabilitation platform consists of three hierarchical components: the "Patient
      Station" (PS), which is installed in the home environment of the patient; the "Hospital
      Station" (HS), which allows an exchange of information with more horsepower and is served by
      the therapists in the hospital; and the "Networking Station" (NS), which allows a combination
      of a plurality of HS.

      The PS consists of a standard laptop with a specifically created for the rehabilitation
      REWIRE platform and pre-installed software (Università degli Studi di Milano, Italy, Applied
      Intelligent Systems Laboratory Department of Computer Science). In the context of a training
      system connected to the computer, the software enables the collection of data, which are
      recorded as part of the training. In this study only exercises for balance ability are part
      of the training program. The training system consists of a so-called Tymoplate® (Tyromotion,
      Austria), a medical device class 1 with CE certification and approval by the FDA for use in
      neurorehabilitation after stroke. The Tymoplate® is connected to the computer and allows by
      means of a base plate with integrated pressure sensors and custom-developed training
      software, various postural biofeedback exercises. In combination with 3D cameras (Kinect®,
      PrimeSense, CA, USA), the patient sees him-/herself or an avatar in real time on a screen
      which moves in the virtual training environment. By various, attractive and entertaining
      designed training games as well as provided audio-visual feedback and balanced score system,
      patients should be maximum motivated to exercise.

      The HS enables the interaction between patient and therapist and essentially consists of a
      MySQL database with web-based interface. The data collected on each PS can be retrieved from
      the HS and can be used by therapists in order to set up the training program on the PS to
      control and to adjust the difficulty level of the exercises to the individual performance of
      each patient.

      The NS also consists of a database. It links collected training data and the associated
      epidemiological data of different HS at the regional level (potentially also between
      different health institutions) to identify on the application of statistical algorithms
      general models for the description of relaxation processes in rehabilitation medicine.

      In this simple way a frequent and intensive training is without direct therapeutic help in
      the home setting at low cost possible. By attractive and entertaining designed training games
      as well as interaction and feedback by the therapist, patients are motivated to train each
      day with the system and to continually improve in the games. The supervision of the training
      by the therapist with the rehabilitation platform REWIRE additionally serves to recognize
      improvements of the individual performance or problems and to adapt the difficulty level of
      the exercises.

      For Patient Registries

        -  Patient recruitment Suitable stationed patients at Cereneo in Vitznau will be informed
           about the possibility of participation in the study. If interested, the patients will
           receive the patient information and can decide within a week whether they will
           participate in the study.

        -  Data collection We will collect data on daily usage of the patient as well as hospital
           stations. Patient usage will be regressed on the patient's deficit severity, age and
           gender to gather preliminary knowledge on whether certain subgroups of patients accept
           the system better than others.

      System usability During and after the pilot trial all involved physicians and physical
      therapists will answer a standardised questionnaire on system usability. Specifically we will
      look at the number of instructions and therapy modifications given to the patient and whether
      the therapist giving the instruction thinks that the patient has reacted accordingly. REWIRE
      will be also evaluated, in terms of usability of software instruments, degree of control of
      the rehabilitation process and value of the results reported by REWIRE.

      - Data management The investigators will use paper case report forms (CRF), one for each
      enrolled study participant, to be filled in with all relevant data pertaining to the subject
      during the study. The investigator will document the participation of each study subject on
      the enrolment log.

      All requested information in the CRF should be completed in a neat legible manner. Use of a
      black ball pen is recommended to ensure clarity of reproduced copies in the CRF. All
      corrections in a paper CRF must be made in a way that does not obscure the original entry.
      The correct data must be inserted, dated and initialled by the investigator Data that are not
      available or not done should be made clear by adding NA or ND. A declaration ensuring
      accuracy of data recorded in the case report forms must be signed by the investigator.

      CRFs will be kept current to reflect subject status at each phase during the course of study.
      Subjects will not to be identified in the CRF by name. Appropriate coded identification (e.g.
      subject number) will be used.

      It will be assured that any authorised person, who may perform data entries and changes in
      the CRF, can be identified. A list with signatures and initials of all authorised persons
      will be filed in the study site file and the trial master file, respectively.

      Documented medical histories and narrative statements relative to the subject's progress
      during the study will be maintained. These records will also include the following: originals
      or copies of laboratory and other medical test results which must be kept on file with the
      individual subject's CRF.

      The CIP will specify what will be maintained for each subject. The investigators assure to
      perform a complete and accurate documentation of the subject data in the CRF. All data
      entered into the CRF with exception of (for which data the CRF will be source data to be
      specified for each study) must also be available in the individual subject file either as
      print-outs or as notes taken by either the investigator or another responsible person
      assigned by the investigator.

      Data which is not included in the CRF will be stored in a secured access database.

      Essential documents must be retained for at least 10 years after the regular end or a
      premature termination of the respective study (VKlin Art. 25). Essential documents will be
      retained according to local law in case of international multicentre studies.

      Any patient files and source data must be archived for the longest possible period of time
      according to the feasibility of the investigational site, institution or private practice.

        -  Reporting for adverse events Adverse events will be reported to the Ethics Committee
           northwest/ central Switzerland EKNZ.

        -  Change management Sample size assessment to specify the number of participants or
           participant years necessary to demonstrate an effect Number of patients: 15 stroke
           patients. Due to the likely large heterogeneity of the study population (different
           weights severity of paresis and ataxia, as well as partly cognitive deficits) a
           sufficiently large number of patients must be tested. Currently, there are no data which
           would allow a power analysis with respect to the primary or secondary end point. In case
           of premature withdrawl from the study, those participants will be replaced so that at
           least 16 participants carry out the 3-month training program completely.

      Plan for missing data to address situations where variables are reported as missing,
      unavailable, "non-reported," uninterpretable, or considered missing because of data
      inconsistency or out-of-range results If in individual clinical tests the data is missing,
      the concerning test cannot be analysed and will not be considered.

      Statistical analysis plan describing the analytical principles and statistical techniques to
      be employed in order to address the primary and secondary objectives, as specified in the
      study protocol or plan Primarily, the feasibility of the technical and practical
      implementation of the rehabilitation REWIRE platform will be evaluated in the
      home-environment of the study participants. Furthermore, the satisfaction and patient
      compliance and acceptance of the system by the attending physicians and therapists will be
      measured. Therefore, structured-standardized questionnaires are used and the quality (if
      numerically tangible) will be evaluated by means of Likert scales. Secondary, the effects to
      use the training system on the functional recovery and quality of life as well as on the
      structural plasticity of the brain will be evaluated. In terms of functional recovery and
      quality of life correlation analyses will be performed. Related data from stroke patients
      (from the stroke registry ZORRO, KEK-ZH-E-08/2009) will be compared with those from the
      REWIRE-study. The evaluation of the data measured by means of magnetic resonance imaging,
      require before carrying out a correlation analysis the application of parametric statistical
      methods.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proof of concept
time frame: week 12
description: Technical and practical implementation of the rehabilitation platform REWIRE will be evaluated, by a questionnaire.
measure: Quality of life
time frame: week 12
description: Assessments, change from Baseline :
Stroke Impact Scale
EuroQol
FES-I (Erfassung der sturzassoziierten Selbstwirksamkeit, 10 min)
Technology Acceptance Model / TAM
measure: functional recovery
time frame: week 12
description: Assessment, change from Baseline:
fMRI
arm group label: REWIRE-System
arm group type: Experimental
description: The training system consists of a so-called Tymoplate® (Tyromotion, Austria), a medical device class 1 with CE certification and approval by the FDA for use in neurorehabilitation after stroke. The Tymoplate® is connected to a computer and allows by means of a base plate with integrated pressure sensors and custom-developed training software different postural biofeedback exercise.
intervention type: Device
intervention name: REWIRE-System
description: The REWIRE rehabilitation platform consists of three hierarchical components:
"patient station" (PS), which is installed in the home environment of the patient:
Includes:
Laptop with software - Game Tymoplate® - balanceboard Kinect® - 3D tracking
"Hospital Station" (HS), which allows an exchange of information with more "patient station" and is served by the therapists in the hospital;
Includes:
Laptop MySQL- database
"station networking" (NS), which allows a combination of a several of HS. database
arm group label: REWIRE-System
other name: Tymoplate®
other name: Kinect®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea R Luft, Prof.
role: Principal Investigator
affiliation: University of Zurich
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Stroke