<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/NCT03036033</url>
  </required_header>
  <id_info>
    <org_study_id>GN16ST162</org_study_id>
    <secondary_id>Res16/A169</secondary_id>
    <secondary_id>16/NS/0112</secondary_id>
    <secondary_id>207595</secondary_id>
    <nct_id>NCT03036033</nct_id>
  </id_info>
  <brief_title>The SaeboGlove Evaluation Trial</brief_title>
  <acronym>T-SET</acronym>
  <official_title>The SaeboGlove Evaluation Trial in Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</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>
      This study evaluates the safety, feasibility and usability of a SaeboGlove rehabilitation&#xD;
      device in the treatment of patients who have reduced ability to open their hand due to&#xD;
      weakness after an acute stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SaeboGlove is a new rehabilitation aid that can be used in people with hand weakness&#xD;
      after a neurological injury. It assists the hand to open, which is crucial for people to&#xD;
      grasp, and release everyday objects. It may improve function by doing this but may also help&#xD;
      people with severe weakness take part more fully in therapy sessions. This glove is already&#xD;
      marketed and is being used in some NHS sites. This trial will assess how it could be used in&#xD;
      NHS practice in acute stroke patients and will develop a plan to implement this.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 26, 2017</start_date>
  <completion_date type="Anticipated">July 25, 2017</completion_date>
  <primary_completion_date type="Anticipated">May 25, 2017</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>Single group, open feasibility study of use of a CE marked and available device.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of sessions performed using the SaeboGlove</measure>
    <time_frame>One month</time_frame>
    <description>Feasibility</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Therapy Intensity</measure>
    <time_frame>Cumulative over one month</time_frame>
    <description>Number of movement repetitions performed using the SaeboGlove</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant, Carer and Therapist Usability and Training Questionnaire</measure>
    <time_frame>One month</time_frame>
    <description>Bespoke questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and Block Test</measure>
    <time_frame>One month</time_frame>
    <description>Measure to assess gross dexterity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>One month</time_frame>
    <description>Measure to assess arm function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log (MAL)</measure>
    <time_frame>One month</time_frame>
    <description>Interview intended to examine how much and how well the participant uses arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events related to using the SaeboGlove</measure>
    <time_frame>One month</time_frame>
    <description>Safety</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Stroke</condition>
  <condition>Cerebral Vascular Disorder</condition>
  <condition>Brain Diseases</condition>
  <condition>Central Nervous System Diseases</condition>
  <condition>Nervous System Diseases</condition>
  <condition>Vascular Diseases</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>SaeboGlove Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SaeboGlove</intervention_name>
    <description>All participants are given a Saebo glove to use during their stroke recovery.</description>
    <arm_group_label>SaeboGlove Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to consent&#xD;
&#xD;
          2. Aged ≥18 years&#xD;
&#xD;
          3. Diagnosis of stroke occurring ≤30 days ago&#xD;
&#xD;
          4. Reduced active range of movement wrist and / or finger extension&#xD;
&#xD;
          5. Modified ashworth score at wrist and fingers ≤ 2&#xD;
&#xD;
          6. Some initiation of gross active finger flexion&#xD;
&#xD;
          7. At least 10 degrees passive range of motion wrist extension&#xD;
&#xD;
          8. Considered able to learn to don / doff a SaeboGlove +/- help of willing carer&#xD;
&#xD;
          9. Ability to engage in some independent rehabilitation +/- help of willing carer&#xD;
&#xD;
         10. Considered able to comply with the requirements of protocol?&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of &gt;5-10 degrees digital contractures&#xD;
&#xD;
          2. Presence of other upper limb impairment that would influence participation (e.g. fixed&#xD;
             contracture, frozen shoulder, severe arthritis or upper limb pain)&#xD;
&#xD;
          3. Presence of other conditions likely to influence participation (e.g. medically&#xD;
             unstable, registered blind, terminal cancer, severe mood, cognitive or language&#xD;
             issues)&#xD;
&#xD;
          4. Participating in another stroke rehabilitation trial&#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>Dr Jesse Dawson</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jen Alexander</last_name>
    <phone>0141 451 5870</phone>
    <phone_ext>85870</phone_ext>
    <email>jen.alexander@ggc.scot.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dr Jesse Dawson</last_name>
    <phone>0141 451 5868</phone>
    <phone_ext>85868</phone_ext>
    <email>Jesse.Dawson@glasgow.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Queen Elizabeth University Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jen Alexander</last_name>
      <phone>0141 451 5870</phone>
      <phone_ext>85870</phone_ext>
      <email>jen.alexander@ggc.scot.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Dr Jesse Dawson</last_name>
      <phone>0141 451 5868</phone>
      <phone_ext>85868</phone_ext>
      <email>Jesse.Dawson@glasgow.ac.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Elizabeth Colquhoun</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>NHS Greater Glasgow and Clyde</investigator_affiliation>
    <investigator_full_name>Dr Jesse Dawson</investigator_full_name>
    <investigator_title>Clinical Reader</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Vascular Diseases</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/NCT03036033
org study id: GN16ST162
secondary id: Res16/A169
secondary id: 16/NS/0112
secondary id: 207595
nct id: NCT03036033
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the safety, feasibility and usability of a SaeboGlove rehabilitation
      device in the treatment of patients who have reduced ability to open their hand due to
      weakness after an acute stroke.
The SaeboGlove is a new rehabilitation aid that can be used in people with hand weakness
      after a neurological injury. It assists the hand to open, which is crucial for people to
      grasp, and release everyday objects. It may improve function by doing this but may also help
      people with severe weakness take part more fully in therapy sessions. This glove is already
      marketed and is being used in some NHS sites. This trial will assess how it could be used in
      NHS practice in acute stroke patients and will develop a plan to implement this.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group, open feasibility study of use of a CE marked and available device.
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Number of sessions performed using the SaeboGlove
time frame: One month
description: Feasibility
measure: Therapy Intensity
time frame: Cumulative over one month
description: Number of movement repetitions performed using the SaeboGlove
measure: Participant, Carer and Therapist Usability and Training Questionnaire
time frame: One month
description: Bespoke questionnaire
measure: Box and Block Test
time frame: One month
description: Measure to assess gross dexterity
measure: Action Research Arm Test (ARAT)
time frame: One month
description: Measure to assess arm function
measure: Motor Activity Log (MAL)
time frame: One month
description: Interview intended to examine how much and how well the participant uses arm
measure: Number of adverse events related to using the SaeboGlove
time frame: One month
description: Safety
arm group label: SaeboGlove Therapy
arm group type: Experimental
description: All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program.
intervention type: Device
intervention name: SaeboGlove
description: All participants are given a Saebo glove to use during their stroke recovery.
arm group label: SaeboGlove Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Jesse Dawson
role: Principal Investigator
affiliation: University of Glasgow
last name: Jen Alexander
phone: 0141 451 5870
phone ext: 85870
email: jen.alexander@ggc.scot.nhs.uk
last name: Dr Jesse Dawson
phone: 0141 451 5868
phone ext: 85868
email: Jesse.Dawson@glasgow.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: NHS Greater Glasgow and Clyde
investigator full name: Dr Jesse Dawson
investigator title: Clinical Reader
mesh term: Nervous System Diseases
mesh term: Brain Diseases
mesh term: Central Nervous System Diseases
mesh term: Cerebrovascular Disorders
mesh term: Cardiovascular Diseases
mesh term: Vascular Diseases
sharing ipd: No