<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/NCT04405609</url>
  </required_header>
  <id_info>
    <org_study_id>ArmAssist 2.0</org_study_id>
    <nct_id>NCT04405609</nct_id>
  </id_info>
  <brief_title>Usability Study of &quot;ArmAssist 2.0.&quot; Robot: Homecare Arm Rehabilitation in Stroke Patients</brief_title>
  <acronym>PUAA</acronym>
  <official_title>Usability Study of &quot;ArmAssist 2.0.&quot; Robot: Homecare Arm Rehabilitation in Acute, Subacute and Chronic Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maimónides Biomedical Research Institute of Córdoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TECNALIA Research &amp; Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GMV Innovating Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maimónides Biomedical Research Institute of Córdoba</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 purpose of this study is to validate the usability of ArmAssist medical device, a robotic&#xD;
      system for the rehabilitation of upper limbs in stroke patients (based on serious games).&#xD;
      This study evaluate the usability of the system in a home environment, taking into account&#xD;
      the ease-to-use, consistency and others; and will pretend demonstrate the feasibility of&#xD;
      including or no, robotic therapy in home like complement of daily rehabilitation program.&#xD;
      Finally this study investigate the acceptance from patients and therapists.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 28, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale</measure>
    <time_frame>Through study completion, an average of 3 weeks</time_frame>
    <description>The purpose of this scale is to evaluate how satisfied the patient are with the assistive device and the related services they experienced. It consists of twelve questions, eight related to the device and four related to services of 12 satisfaction items with answers from 1 'Not satisfied at all' to 5 'Very satisfied'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>System Usability Scale: SUS</measure>
    <time_frame>Through study completion, an average of 3 weeks</time_frame>
    <description>This scale provides a quick, reliable tool for measuring the usability. It consists of 10 item questionnaire and answers from 1 'strongly agree' to 5 'strongly disagree'. Scores are ranging to 0-100 %, where a high score means better usability with a higher score meaning better usability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intrinsic Motivation Inventory: IMI</measure>
    <time_frame>Through study completion, an average of 3 weeks</time_frame>
    <description>This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usability questionnaire specifically designed for the use of ArmAssist 2.0</measure>
    <time_frame>Through study completion, an average of 3 weeks</time_frame>
    <description>It consists of a 19 item questionnaire with seven response options (Likert sacle) for respondents; from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients and therapist with the system and the therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Structured interviews: Willingness-to-pay questionnaire</measure>
    <time_frame>Through study completion, an average of 3 weeks</time_frame>
    <description>This interview consists in two short questions to ask to participants about the willingness-to-pay for ArmAssist 2.0. system as therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment (FMA) scale</measure>
    <time_frame>Baseline, 3 weeks</time_frame>
    <description>It is an index to assess the sensorimotor impairment in individuals who have had stroke. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximun score is 66 points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Asworth Scale (MAS)</measure>
    <time_frame>Baseline, 3 weeks</time_frame>
    <description>This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Stroke</condition>
  <condition>Rehabilitation</condition>
  <condition>Upper Limb Rehabilitation</condition>
  <condition>Telerehabilitation</condition>
  <condition>Robot-assisted Therapy</condition>
  <arm_group>
    <arm_group_label>ArmAssist group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The post-stroke patients who participate in the study, are classified in differents stages (3 patients in each stage).&#xD;
Group 1: subacute, between 2 - 6 months Group 2: chronic of short evolution, between 6 - 12 months Group 3: long-term chronic, more than 12 months.&#xD;
The system is tested in a clinical (training) and patients' home setting. The ArmAssist system includes the ArmAsist 2.0 device (without motors), the tele rehabilitation platform based on serious games and Antari's HomeCare tele-care platform for the clinicians.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ArmAssist</intervention_name>
    <description>The usability study protocol include 3 ArmAssist systems (2 designed for the left hand and one for the right hand) that could not be used in parallel because the aim of the study was to bring the systems to the home environment during part of the evaluation.&#xD;
The usability study is carried out in two phases:&#xD;
First phase: 5 weeks.&#xD;
Second phase: 3 weeks. Each phase included a week of training at the Hospital or IMIBIC facilities with a physiotherapist, and then 2 weeks at the patient's home, being the first one with the physiotherapist supervision and the second one by their own with the possibility of physiotherapist remote support.</description>
    <arm_group_label>ArmAssist group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects over 18,&#xD;
&#xD;
          -  Upper limb hemiparesis after stroke,&#xD;
&#xD;
          -  Unilateral paresis and cognitive ability to understand,&#xD;
&#xD;
          -  Accept and actively participate in the usability study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral motor deficit,&#xD;
&#xD;
          -  Severe spasticity,&#xD;
&#xD;
          -  Psychiatric illness,&#xD;
&#xD;
          -  and/or cognitive impairment.&#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 Jesus Mayordomo Riera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Reina Sofia de Córdoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofía de Córdoba</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Cerebrovascular Disorders</keyword>
  <keyword>Robotic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All the collected information will be available for other researchers upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Up to 12 months after trials publication.</ipd_time_frame>
    <ipd_access_criteria>Request by e-mail to uicec@imibic.org</ipd_access_criteria>
  </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/NCT04405609
org study id: ArmAssist 2.0
nct id: NCT04405609
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to validate the usability of ArmAssist medical device, a robotic
      system for the rehabilitation of upper limbs in stroke patients (based on serious games).
      This study evaluate the usability of the system in a home environment, taking into account
      the ease-to-use, consistency and others; and will pretend demonstrate the feasibility of
      including or no, robotic therapy in home like complement of daily rehabilitation program.
      Finally this study investigate the acceptance from patients and therapists.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quebec User Evaluation of Satisfaction with assistive Technology: QUEST scale
time frame: Through study completion, an average of 3 weeks
description: The purpose of this scale is to evaluate how satisfied the patient are with the assistive device and the related services they experienced. It consists of twelve questions, eight related to the device and four related to services of 12 satisfaction items with answers from 1 'Not satisfied at all' to 5 'Very satisfied'
measure: System Usability Scale: SUS
time frame: Through study completion, an average of 3 weeks
description: This scale provides a quick, reliable tool for measuring the usability. It consists of 10 item questionnaire and answers from 1 'strongly agree' to 5 'strongly disagree'. Scores are ranging to 0-100 %, where a high score means better usability with a higher score meaning better usability
measure: Intrinsic Motivation Inventory: IMI
time frame: Through study completion, an average of 3 weeks
description: This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'.
measure: Usability questionnaire specifically designed for the use of ArmAssist 2.0
time frame: Through study completion, an average of 3 weeks
description: It consists of a 19 item questionnaire with seven response options (Likert sacle) for respondents; from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients and therapist with the system and the therapy.
measure: Structured interviews: Willingness-to-pay questionnaire
time frame: Through study completion, an average of 3 weeks
description: This interview consists in two short questions to ask to participants about the willingness-to-pay for ArmAssist 2.0. system as therapy.
measure: Fugl-Meyer Assessment (FMA) scale
time frame: Baseline, 3 weeks
description: It is an index to assess the sensorimotor impairment in individuals who have had stroke. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximun score is 66 points
measure: Modified Asworth Scale (MAS)
time frame: Baseline, 3 weeks
description: This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension.
arm group label: ArmAssist group
arm group type: Experimental
description: The post-stroke patients who participate in the study, are classified in differents stages (3 patients in each stage).
Group 1: subacute, between 2 - 6 months Group 2: chronic of short evolution, between 6 - 12 months Group 3: long-term chronic, more than 12 months.
The system is tested in a clinical (training) and patients' home setting. The ArmAssist system includes the ArmAsist 2.0 device (without motors), the tele rehabilitation platform based on serious games and Antari's HomeCare tele-care platform for the clinicians.
intervention type: Device
intervention name: ArmAssist
description: The usability study protocol include 3 ArmAssist systems (2 designed for the left hand and one for the right hand) that could not be used in parallel because the aim of the study was to bring the systems to the home environment during part of the evaluation.
The usability study is carried out in two phases:
First phase: 5 weeks.
Second phase: 3 weeks. Each phase included a week of training at the Hospital or IMIBIC facilities with a physiotherapist, and then 2 weeks at the patient's home, being the first one with the physiotherapist supervision and the second one by their own with the possibility of physiotherapist remote support.
arm group label: ArmAssist group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fernando Jesus Mayordomo Riera, MD
role: Principal Investigator
affiliation: Hospital Universitario Reina Sofia de Córdoba
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Yes
ipd description: All the collected information will be available for other researchers upon request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Up to 12 months after trials publication.
ipd access criteria: Request by e-mail to uicec@imibic.org