<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/NCT04459559</url>
  </required_header>
  <id_info>
    <org_study_id>RZS_01_2020</org_study_id>
    <nct_id>NCT04459559</nct_id>
  </id_info>
  <brief_title>Usability of a Novel Cueing Device for Patients With Parkinson's Disease</brief_title>
  <acronym>TCP</acronym>
  <official_title>Usability Study of a Novel Tactile Cueing Device for Patients With Parkinson's Disease: A Monocentric Interventional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rehaklinik Zihlschlacht AG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Federal Institute of Technology</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>
      Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced&#xD;
      stage of Parkinson's disease (PD). These impair quality of life and significantly increase&#xD;
      the risk of falls. External movement pacemakers have been developed to improve gait and avert&#xD;
      FOG by cueing strategies. The investigators developed a smart, small and lightweight,&#xD;
      easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse&#xD;
      generators and a battery-driven power supply. The device is programmed via a Graphical User&#xD;
      Interface (GUI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 16, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Setup cueing device</measure>
    <time_frame>2 weeks</time_frame>
    <description>Time needed for the setup [in seconds] and the variations of the different setup parameters (cueing length [seconds], cueing strength [% of maximum], cueing cadence [count/minutes]) between the days of usage. Overall descriptive summary of the variation between the different setup parameters during the days of usage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usability</measure>
    <time_frame>2 weeks</time_frame>
    <description>Usability of the cueing device is measured by a self-developed questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptance</measure>
    <time_frame>2 weeks</time_frame>
    <description>Acceptance is measured by a self-developed questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency using the device</measure>
    <time_frame>2 weeks</time_frame>
    <description>How often the device is used (counts logging protocol).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking speed [meters/second]</measure>
    <time_frame>1 week</time_frame>
    <description>Calculated by the assessments 10 meter walk test and 2-minute walk test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cadence [steps/minute]</measure>
    <time_frame>1 week</time_frame>
    <description>Number during 10 meter walk test. Also measured by a system of movement analysis (C-Mill MOTEK).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking distance [in meters]</measure>
    <time_frame>1 week</time_frame>
    <description>Measured by a digital measuring wheel during 2-minute walk test. Also measured by a system of movement analysis (C-Mill MOTEK).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step length right/left [in meters]</measure>
    <time_frame>1 week</time_frame>
    <description>Measured by a system of movement analysis (C-Mill MOTEK).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initial step latency [in seconds]</measure>
    <time_frame>1 week</time_frame>
    <description>Extracted from video documentation by a blinded rater.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of FOG</measure>
    <time_frame>1 week</time_frame>
    <description>Extracted from video documentation by a blinded rater.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Freezing of Gait</condition>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using the Tactile Cueing Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tactile Cueing Device</intervention_name>
    <description>Each participant receives an individual training on how to use the Tactile Cueing Device and the set-up of the TCD will be done according to the results of a 10MWT and the participant's preferences. Gait assessments with an activated or deactivated TCD are executed using the Timed Up and Go test, the 2-Minute Waling test and a treadmill (C-Mill). Also a long-term test run of the TCD during one day is planned.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Include patients who suffer from advanced PD. Characteristic symptoms of parkinsonian&#xD;
             gait like hypokinetic movements and/or FOG have to be present.&#xD;
&#xD;
          -  Parkinsonian gait is measured by the following items of the Movement Disorder Society&#xD;
             Unified Parkinson Disease Rating Scale (MDS-UPDRS): item 2.12, item 2.13, item 3.10&#xD;
             and item 3.11. The Hoehn and Yahr (HY) stage during ON is 1-4/5.&#xD;
&#xD;
          -  MoCA ≥ 22/30.&#xD;
&#xD;
          -  Participant has signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability of the participant to understand the IC or to follow the procedures of the&#xD;
             study (as judged by the Qualified Physician).&#xD;
&#xD;
          -  Significantly, impaired cognitive skills render the participant unable to use the TCD.&#xD;
&#xD;
          -  Presence of severe motor fluctuations and severely impaired walking ability as defined&#xD;
             by HY stage V during ON.&#xD;
&#xD;
          -  Clinically relevant skin lesions on the wrist or fixation points (usually the thighs).&#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>Raoul Schweinfurther, M.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehaklinik Zihlschlacht AG</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raoul Schweinfurther, M.A.</last_name>
    <phone>+41 71 424 3118</phone>
    <email>r.schweinfurther@rehaklinik-zihlschlacht.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carsten Möller, Prof.</last_name>
    <phone>+41 71 424 3021</phone>
    <email>C.Moeller@rehaklinik-zihlschlacht.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rehaklinik Zihlschlacht AG</name>
      <address>
        <city>Zihlschlacht</city>
        <state>Thurgau</state>
        <zip>8588</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raoul Schweinfurther, M.A. Sport Science</last_name>
      <phone>+41 71 424 3118</phone>
      <email>R.Schweinfurther@rehaklinik-zihlschlacht.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Bachlin M, Plotnik M, Roggen D, Maidan I, Hausdorff JM, Giladi N, Troster G. Wearable assistant for Parkinson's disease patients with the freezing of gait symptom. IEEE Trans Inf Technol Biomed. 2010 Mar;14(2):436-46. doi: 10.1109/TITB.2009.2036165. Epub 2009 Nov 10.</citation>
    <PMID>19906597</PMID>
  </reference>
  <reference>
    <citation>Baker K, Rochester L, Nieuwboer A. The effect of cues on gait variability--reducing the attentional cost of walking in people with Parkinson's disease. Parkinsonism Relat Disord. 2008;14(4):314-20. doi: 10.1016/j.parkreldis.2007.09.008. Epub 2007 Nov 7.</citation>
    <PMID>17988925</PMID>
  </reference>
  <reference>
    <citation>Giladi N, Nieuwboer A. Understanding and treating freezing of gait in parkinsonism, proposed working definition, and setting the stage. Mov Disord. 2008;23 Suppl 2:S423-5. doi: 10.1002/mds.21927. No abstract available. Erratum In: Mov Disord. 2008 Aug 15;23(11):1639-40.</citation>
    <PMID>18668629</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</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>Parkinson Disease</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/NCT04459559
org study id: RZS_01_2020
nct id: NCT04459559
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced
      stage of Parkinson's disease (PD). These impair quality of life and significantly increase
      the risk of falls. External movement pacemakers have been developed to improve gait and avert
      FOG by cueing strategies. The investigators developed a smart, small and lightweight,
      easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse
      generators and a battery-driven power supply. The device is programmed via a Graphical User
      Interface (GUI).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
primary purpose: Treatment
masking: None (Open Label)
measure: Setup cueing device
time frame: 2 weeks
description: Time needed for the setup [in seconds] and the variations of the different setup parameters (cueing length [seconds], cueing strength [% of maximum], cueing cadence [count/minutes]) between the days of usage. Overall descriptive summary of the variation between the different setup parameters during the days of usage.
measure: System Usability Scale
time frame: 2 weeks
description: Items defined by the System Usability Scale: 5-point Likert scale ('strongly disagree' to 'strongly agree').
measure: Usability
time frame: 2 weeks
description: Usability of the cueing device is measured by a self-developed questionnaire.
measure: Acceptance
time frame: 2 weeks
description: Acceptance is measured by a self-developed questionnaire.
measure: Frequency using the device
time frame: 2 weeks
description: How often the device is used (counts logging protocol).
measure: Walking speed [meters/second]
time frame: 1 week
description: Calculated by the assessments 10 meter walk test and 2-minute walk test.
measure: Cadence [steps/minute]
time frame: 1 week
description: Number during 10 meter walk test. Also measured by a system of movement analysis (C-Mill MOTEK).
measure: Walking distance [in meters]
time frame: 1 week
description: Measured by a digital measuring wheel during 2-minute walk test. Also measured by a system of movement analysis (C-Mill MOTEK).
measure: Step length right/left [in meters]
time frame: 1 week
description: Measured by a system of movement analysis (C-Mill MOTEK).
measure: Initial step latency [in seconds]
time frame: 1 week
description: Extracted from video documentation by a blinded rater.
measure: Number of FOG
time frame: 1 week
description: Extracted from video documentation by a blinded rater.
arm group label: Intervention
arm group type: Experimental
description: Using the Tactile Cueing Device
intervention type: Device
intervention name: Tactile Cueing Device
description: Each participant receives an individual training on how to use the Tactile Cueing Device and the set-up of the TCD will be done according to the results of a 10MWT and the participant's preferences. Gait assessments with an activated or deactivated TCD are executed using the Timed Up and Go test, the 2-Minute Waling test and a treadmill (C-Mill). Also a long-term test run of the TCD during one day is planned.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raoul Schweinfurther, M.A.
role: Principal Investigator
affiliation: Rehaklinik Zihlschlacht AG
last name: Raoul Schweinfurther, M.A.
phone: +41 71 424 3118
email: r.schweinfurther@rehaklinik-zihlschlacht.ch
last name: Carsten Möller, Prof.
phone: +41 71 424 3021
email: C.Moeller@rehaklinik-zihlschlacht.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
citation: Bachlin M, Plotnik M, Roggen D, Maidan I, Hausdorff JM, Giladi N, Troster G. Wearable assistant for Parkinson's disease patients with the freezing of gait symptom. IEEE Trans Inf Technol Biomed. 2010 Mar;14(2):436-46. doi: 10.1109/TITB.2009.2036165. Epub 2009 Nov 10.
PMID: 19906597
citation: Baker K, Rochester L, Nieuwboer A. The effect of cues on gait variability--reducing the attentional cost of walking in people with Parkinson's disease. Parkinsonism Relat Disord. 2008;14(4):314-20. doi: 10.1016/j.parkreldis.2007.09.008. Epub 2007 Nov 7.
PMID: 17988925
citation: Giladi N, Nieuwboer A. Understanding and treating freezing of gait in parkinsonism, proposed working definition, and setting the stage. Mov Disord. 2008;23 Suppl 2:S423-5. doi: 10.1002/mds.21927. No abstract available. Erratum In: Mov Disord. 2008 Aug 15;23(11):1639-40.
PMID: 18668629
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No