xml: <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/NCT05995665</url>
    </required_header>
    <id_info>
      <org_study_id>2020/01105</org_study_id>
      <nct_id>NCT05995665</nct_id>
      <nct_alias>NCT05494489</nct_alias>
    </id_info>
    <brief_title>Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients</brief_title>
    <official_title>Assistive Soft Robotic Glove (EsoGLOVE) Intervention for Stroke Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandra Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jurong Community Hospital, Singapore</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Roceso Technologies</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Alexandra Hospital</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE with&#xD;
        Trigno Biofeedback (EMG sensors) in the inpatient rehabilitation setting. 1. Understanding&#xD;
        the ability of the EsoGLOVE with Trigno Biofeedback (EMG sensors) in providing CPM exercise&#xD;
        and assisting stroke patients with completing hand functional tasks, eventually improves&#xD;
        patients' motor function and neural recovery.2. To generate evidence on this innovative&#xD;
        device and further deploy it in clinical practice. A Health Technology Assessment (HTA) will&#xD;
        be generated from this study to evaluate the cost-effectiveness of the intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This project proposes a study of 130 subjects in inpatient settings who have sustained their&#xD;
        first-ever stroke prior to clinical trial enrolment. Participants are randomly assigned to 2&#xD;
        groups (EsoGLOVE with Trigno Biofeedback (EMG sensors) group and GRASP group). The&#xD;
        randomization method: A block randomization with a randomly varying block size. The study&#xD;
        will last 12 weeks (3 weeks of intervention during hospitalization + 12th-week outpatient&#xD;
        follow-up post-discharge). The subjects will use the study device about 15 times and be&#xD;
        followed up for 3 weeks during hospitalization.&#xD;
  &#xD;
        The subjects will need to visit the doctor's office 1 time (outpatient follow-up&#xD;
        post-discharge) in the course of the study.During the hospitalization, the stroke patients&#xD;
        (subjects) will receive intensive stroke rehabilitation as per normal, which will be daily&#xD;
        physiotherapy and occupational therapy as a part of standard care as per stroke&#xD;
        rehabilitation. On top of the standard care (daily Inpatient OT Rehabilitation), the EsoGLOVE&#xD;
        + Trigno subjects will receive EsoGLOVE with Trigno Biofeedback (EMG sensors) training on&#xD;
        therapy day for 3 weeks (week 1 to week 3, sessions will be done every Monday to Friday), a&#xD;
        minimum of 30 minutes per day. While the GRASP group subjects will receive the Graded&#xD;
        Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a&#xD;
        minimum of 30 minutes per day.In the case of early discharge or withdrawal for any reason&#xD;
        before the 3-week intervention is completed, the subjects will no longer participate in this&#xD;
        study and no study-related activities will be performed on the subjects. The subjects' right&#xD;
        to receive standard care will remain the same as per hospital guidelines and will not be&#xD;
        affected. This is applicable to both groups. With minimal compliance rate (12 sessions) for&#xD;
        continuing the study, regardless of the subjects' discharge before 3 weeks, otherwise (less&#xD;
        than or equal to 11 sessions) subjects will be withdrawn at the day of discharge or&#xD;
        withdrawal. The 12th-week outpatient follow-up post-discharge at the clinic will coincide&#xD;
        with the subject's standard care follow-up visit.The Health Technology Assessment (HTA) is&#xD;
        conducted by the study team using explicit analytical frameworks, clinical outcomes,&#xD;
        epidemiological data amp; statistics, health economic information, and study methodology. The&#xD;
        assessment includes building evidence on the qualities and costs of health interventions&#xD;
        (cost-effectiveness), identifying the direct amp; indirect medical costs in the current&#xD;
        healthcare system, capturing the clinical outcomes of interventions, synthesizing health&#xD;
        research findings of the effectiveness of different health interventions, evaluating the&#xD;
        economic implications and analyzing the cost-effectiveness of the intervention.It is unlikely&#xD;
        this study might unintentionally come to know of new information (Incidental Finding) about&#xD;
        the health condition from the assessment (Fugl-Meyer Assessment - Upper Extremity) of the&#xD;
        study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 11, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fugl Meyer Assessment - Upper Extremity (FMA-UE)</measure>
      <time_frame>2 years</time_frame>
      <description>To achieve minimum of 6 FMA-UE scores difference/change between treatments and pre &amp; post intervention (3th - 0th week).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>EsoGLOVE with Trigno Biofeedback (EMG sensors) group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The EsoGLOVE + Trigno Biofeedback Group subjects will receive EsoGLOVE with Trigno Biofeedback (EMG sensors) training on therapy day for 3 weeks (week 1 to week 3, sessions will be done every Monday to Friday), a minimum of 30 minutes per day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Graded Repetitive Arm Supplementary Program (GRASP) Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The GRASP group subjects will receive the Graded Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EsoGLOVE with Trigno Biofeedback (EMG sensors)</intervention_name>
      <description>The dose is referred to the stay of inpatient setting. The stroke patients will be transferred to community hospital when medically stable. The average of stay in community hospital is 3 weeks. The stroke patients will receive intensive stroke rehabilitation during the stay, which will be daily physiotherapy and occupational therapy. The subjects will receive EsoGLOVETM with Trigno Biofeedback (EMG sensors) training on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day. A total of 15 sessions (5 session per week for a total of 3 weeks) of a minimum of 30 mins. This is similar to the dose in a similar trial (DSRB 2017/00312, Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture).</description>
      <arm_group_label>EsoGLOVE with Trigno Biofeedback (EMG sensors) group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Graded Repetitive Arm Supplementary Program (GRASP)</intervention_name>
      <description>Graded Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day.</description>
      <arm_group_label>Graded Repetitive Arm Supplementary Program (GRASP) Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 30-90 years regardless of lesion size, race&#xD;
  &#xD;
            2. Stroke type: ischemic or haemorrhagic&#xD;
  &#xD;
            3. Medically stable conditions&#xD;
  &#xD;
            4. Fugl-Meyer Assessment (FMA) of upper extremity impairment of 10-56 out of 66.&#xD;
  &#xD;
            5. Able to give own consent, comprehend and follow commands&#xD;
  &#xD;
            6. Able to sit upright and maintain sitting balance for at least 30 minutes&#xD;
  &#xD;
            7. Able to stay alert and focus on the tasks at least 30 minutes and more.&#xD;
  &#xD;
            8. Unilateral upper limb impairment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Recurrent stroke&#xD;
  &#xD;
            2. Unstable medical conditions (e.g. heart attack, unstable blood pressure, infection,&#xD;
               and etc.) or anticipated life expectancy of &lt;1 year.&#xD;
  &#xD;
            3. Cognitive and communicative impairment (e.g. severe receptive aphasia, inattention,&#xD;
               learning difficulty, and etc).&#xD;
  &#xD;
            4. History of severe depression or active psychiatric disorder.&#xD;
  &#xD;
            5. Severe spasticity (Modified Ashworth scale ≥2), joint contractures or deformity, poor&#xD;
               skin conditions (e.g. irritated skin, open wounds), amputation of fingers, and&#xD;
               allergic condition (e.g. patients with allergies to adhesive gel).&#xD;
  &#xD;
            6. Poor trunk control or postural hypotension.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pui Kit Tam, MBBS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Alexandra Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pui Kit Tam, MBBS</last_name>
      <phone>+65 -6779 5555</phone>
      <email>pui_kit_tam@nuhs.edu.sg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Alexandra Hospital</name>
        <address>
          <city>Singapore</city>
          <country>Singapore</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pui Kit Tam, MBBS</last_name>
        <phone>+65-6779 5555</phone>
        <email>pui_kit_tam@nuhs.edu.sg</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jurong Community Hospital</name>
        <address>
          <city>Singapore</city>
          <country>Singapore</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elvina Kai Wen Tay, MBBS</last_name>
        <phone>+65-6716 2000</phone>
        <email>Elvina_Tay@nuhs.edu.sg</email>
      </contact>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 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>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995665
  org study id: 2020/01105
  nct id: NCT05995665
  nct alias: NCT05494489
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE with
        Trigno Biofeedback (EMG sensors) in the inpatient rehabilitation setting. 1. Understanding
        the ability of the EsoGLOVE with Trigno Biofeedback (EMG sensors) in providing CPM exercise
        and assisting stroke patients with completing hand functional tasks, eventually improves
        patients' motor function and neural recovery.2. To generate evidence on this innovative
        device and further deploy it in clinical practice. A Health Technology Assessment (HTA) will
        be generated from this study to evaluate the cost-effectiveness of the intervention.
  This project proposes a study of 130 subjects in inpatient settings who have sustained their
        first-ever stroke prior to clinical trial enrolment. Participants are randomly assigned to 2
        groups (EsoGLOVE with Trigno Biofeedback (EMG sensors) group and GRASP group). The
        randomization method: A block randomization with a randomly varying block size. The study
        will last 12 weeks (3 weeks of intervention during hospitalization + 12th-week outpatient
        follow-up post-discharge). The subjects will use the study device about 15 times and be
        followed up for 3 weeks during hospitalization.
  
        The subjects will need to visit the doctor's office 1 time (outpatient follow-up
        post-discharge) in the course of the study.During the hospitalization, the stroke patients
        (subjects) will receive intensive stroke rehabilitation as per normal, which will be daily
        physiotherapy and occupational therapy as a part of standard care as per stroke
        rehabilitation. On top of the standard care (daily Inpatient OT Rehabilitation), the EsoGLOVE
        + Trigno subjects will receive EsoGLOVE with Trigno Biofeedback (EMG sensors) training on
        therapy day for 3 weeks (week 1 to week 3, sessions will be done every Monday to Friday), a
        minimum of 30 minutes per day. While the GRASP group subjects will receive the Graded
        Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a
        minimum of 30 minutes per day.In the case of early discharge or withdrawal for any reason
        before the 3-week intervention is completed, the subjects will no longer participate in this
        study and no study-related activities will be performed on the subjects. The subjects' right
        to receive standard care will remain the same as per hospital guidelines and will not be
        affected. This is applicable to both groups. With minimal compliance rate (12 sessions) for
        continuing the study, regardless of the subjects' discharge before 3 weeks, otherwise (less
        than or equal to 11 sessions) subjects will be withdrawn at the day of discharge or
        withdrawal. The 12th-week outpatient follow-up post-discharge at the clinic will coincide
        with the subject's standard care follow-up visit.The Health Technology Assessment (HTA) is
        conducted by the study team using explicit analytical frameworks, clinical outcomes,
        epidemiological data amp; statistics, health economic information, and study methodology. The
        assessment includes building evidence on the qualities and costs of health interventions
        (cost-effectiveness), identifying the direct amp; indirect medical costs in the current
        healthcare system, capturing the clinical outcomes of interventions, synthesizing health
        research findings of the effectiveness of different health interventions, evaluating the
        economic implications and analyzing the cost-effectiveness of the intervention.It is unlikely
        this study might unintentionally come to know of new information (Incidental Finding) about
        the health condition from the assessment (Fugl-Meyer Assessment - Upper Extremity) of the
        study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Fugl Meyer Assessment - Upper Extremity (FMA-UE)
  time frame: 2 years
  description: To achieve minimum of 6 FMA-UE scores difference/change between treatments and pre & post intervention (3th - 0th week).
  arm group label: EsoGLOVE with Trigno Biofeedback (EMG sensors) group
  arm group type: Experimental
  description: The EsoGLOVE + Trigno Biofeedback Group subjects will receive EsoGLOVE with Trigno Biofeedback (EMG sensors) training on therapy day for 3 weeks (week 1 to week 3, sessions will be done every Monday to Friday), a minimum of 30 minutes per day
  arm group label: Graded Repetitive Arm Supplementary Program (GRASP) Group
  arm group type: Active Comparator
  description: The GRASP group subjects will receive the Graded Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day
  intervention type: Device
  intervention name: EsoGLOVE with Trigno Biofeedback (EMG sensors)
  description: The dose is referred to the stay of inpatient setting. The stroke patients will be transferred to community hospital when medically stable. The average of stay in community hospital is 3 weeks. The stroke patients will receive intensive stroke rehabilitation during the stay, which will be daily physiotherapy and occupational therapy. The subjects will receive EsoGLOVETM with Trigno Biofeedback (EMG sensors) training on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day. A total of 15 sessions (5 session per week for a total of 3 weeks) of a minimum of 30 mins. This is similar to the dose in a similar trial (DSRB 2017/00312, Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture).
  arm group label: EsoGLOVE with Trigno Biofeedback (EMG sensors) group
  intervention type: Other
  intervention name: Graded Repetitive Arm Supplementary Program (GRASP)
  description: Graded Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day.
  arm group label: Graded Repetitive Arm Supplementary Program (GRASP) Group
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Pui Kit Tam, MBBS
  role: Principal Investigator
  affiliation: Alexandra Hospital
  last name: Pui Kit Tam, MBBS
  phone: +65 -6779 5555
  email: pui_kit_tam@nuhs.edu.sg
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Singapore
  responsible party type: Sponsor
  mesh term: Stroke
  sharing ipd: No