<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/NCT02969967</url>
  </required_header>
  <id_info>
    <org_study_id>H2016:285</org_study_id>
    <nct_id>NCT02969967</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke</brief_title>
  <official_title>Effectiveness of a Dynamic Wrist-hand Orthosis in Early Outpatient Rehabilitation of the Upper Extremity Post Stroke: a Multiple Single Subject Design Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in&#xD;
      improving upper extremity recovery for people in the early phases of rehabilitation post&#xD;
      stroke. The objectives of the study are:&#xD;
&#xD;
        1. to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity&#xD;
           function, strength, movement, spasticity and self-perceived occupational performance, in&#xD;
           addition to conventional therapy, with continued use immediately after discharge from&#xD;
           inpatient stroke rehabilitation and while waiting for outpatient occupational therapy&#xD;
           services&#xD;
&#xD;
        2. to explore the relationship between the participants' level of self-efficacy and use of&#xD;
           the SaeboFlex orthosis in the home environment&#xD;
&#xD;
        3. to explore the participants' experience of use of the SaeboFlex orthosis in the home&#xD;
           environment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although intensive and repetitive use of the paretic upper extremity has been shown to&#xD;
      improve upper extremity outcomes post stroke, few therapeutic approaches allow those with&#xD;
      moderate to severe upper extremity impairment to independently participate in repetitive&#xD;
      grasp and release activities. The SaeboFlex orthosis is a dynamic wrist-hand orthosis that&#xD;
      assists with finger and thumb extension after functional grasping with the paretic hand and&#xD;
      therefore may allow those with more affected upper extremities post stroke to participate in&#xD;
      repetitive grasp and release activities that they otherwise would be unable to do. More&#xD;
      research is required on the effectiveness of this orthosis in improving upper extremity&#xD;
      recovery post stroke especially when used at home as a continuation of therapy received&#xD;
      during inpatient rehabilitation. It has been suggested that guided home rehabilitation&#xD;
      programs can improve the ability of stroke survivors to be more independent in their&#xD;
      activities of daily living. This study is a mixed methods study combining a quantitative&#xD;
      single subject ABA design and qualitative post study individual interviews to first capture&#xD;
      quantitative information on the effectiveness of the SaeboFlex intervention and then&#xD;
      qualitative information that will build on and further explain the quantitative data. Three&#xD;
      participants who are using a SaeboFlex orthosis as part of their upper extremity&#xD;
      rehabilitation program will be recruited from an inpatient stroke rehabilitation unit as they&#xD;
      are being discharged from inpatient rehabilitation and will be seen by the principal&#xD;
      investigator in their homes for 1 hour 3 times a week for 2 weeks and then once a week for 6&#xD;
      weeks while they are on the waiting list for outpatient occupational therapy services. The&#xD;
      intervention will follow a set protocol of grasp-release activities using the SaeboFlex&#xD;
      orthosis for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release&#xD;
      activities without the orthosis, both of which will be graded to provide optimal upper&#xD;
      extremity challenge throughout the intervention period. Repeated baseline assessments will be&#xD;
      completed by a trained research assistant, in the participants' homes, within one week of&#xD;
      discharge from inpatient stroke rehabilitation and will be repeated after 4 and 8 weeks of&#xD;
      intervention, followed by individual interviews in the participants' homes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arm Activity Measure (ArmA)</measure>
    <time_frame>Change from baseline upper extremity function to 4 and 8 weeks</time_frame>
    <description>The Arm Activity Measure (ArmA) is a self-report tool designed for use with upper extremity spasticity management interventions. The ArmA was chosen because it provides a comprehensive assessment at the activity level of both active and passive upper extremity function; it is comprised of an 8 item passive function subscale and a 13 item active function subscale. Both subscales have been found to have high internal consistency and test-retest reliability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7)</measure>
    <time_frame>Change from baseline upper extremity function to 4 and 8 weeks</time_frame>
    <description>The Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7) is a commonly used upper extremity functional assessment post stroke. It is comprised of seven bilateral functional tasks and has been found to have excellent test-retest and inter-rater reliability as well as internal consistency.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment-Upper Extremity (FMA-UE)</measure>
    <time_frame>Change from baseline upper extremity impairment to 4 and 8 weeks</time_frame>
    <description>The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a widely used measure of motor impairment post stroke and is comprised of 33 items related to upper extremity movement. The FMA-UE has excellent inter-rater and test-retest reliability as well as construct validity in persons with stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale (SIS)</measure>
    <time_frame>Change from baseline perception of recovery to 4 and 8 weeks</time_frame>
    <description>The Stroke Impact Scale (SIS) is a well known and well studied measure of stroke survivors' perception of their recovery post stroke. The SIS has been widely used in stroke intervention studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale (MAS)</measure>
    <time_frame>Change from baseline spasticity to 4 and 8 weeks</time_frame>
    <description>The Modified Ashworth Scale (MAS) is a well known measure of spasticity post stroke. The MAS assesses the resistance to passive muscle stretch and is graded on a 6 point ordinal scale. The participants' elbow, wrist and finger flexors will be assessed with the MAS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand Grip Strength (measured using dynamometry)</measure>
    <time_frame>Change from baseline grip strength to 4 and 8 weeks</time_frame>
    <description>Measurement of hand grip strength using dynamometry is common post stroke and has excellent test-retest and inter-rater reliability. An average of 3 grip strength trials will be taken at each measurement point using dynamometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Self-Efficacy Questionnaire (SSEQ)</measure>
    <time_frame>Change from baseline self-efficacy to 4 and 8 weeks</time_frame>
    <description>The Stroke Self-Efficacy Questionnaire (SSEQ) was designed to assess self-efficacy related to functional performance and self-management post stroke. The SSEQ is comprised of two subscales that are scored separately and correlate strongly with other measures of self-efficacy post stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>Change from baseline perception of occupational performance to 4 and 8 weeks</time_frame>
    <description>The Canadian Occupational Performance Measure (COPM) is a valid and responsive measure of occupational performance and has been widely used in stroke research. The COPM uses a semi-structured interview format where performance and satisfaction scores will be identified for the participants' self-identified occupational performance issues.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Individual interviews</measure>
    <time_frame>8 weeks</time_frame>
    <description>Individual interviews will be conducted at 8 weeks, after the intervention is complete, to generate discussion about the perceived usability of the SaeboFlex orthosis in the home environment, the perceived effect on upper extremity recovery as well as the perceived relationship between self-efficacy and use of the SaeboFlex orthosis in the home environment.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>SaeboFlex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the SaeboFlex orthosis for a set protocol of grasp-release activities</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SaeboFlex</intervention_name>
    <description>Use of the SaeboFlex orthosis for a set protocol of grasp-release activities for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis for 8 weeks. Will occur in participants' homes after discharge from inpatient rehabilitation with visit from principal investigator to progress program for 1 hour 3 times a week for the first 2 weeks and then once a week for 6 weeks.</description>
    <arm_group_label>SaeboFlex</arm_group_label>
    <other_name>functional dynamic orthosis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults aged 18 or over who have had a first stroke within the past 6 months&#xD;
&#xD;
          -  admitted to Riverview Health Centre (Winnipeg, Canada) for stroke rehabilitation and&#xD;
             are being discharged to home locations within the city of Winnipeg&#xD;
&#xD;
          -  fit with and started using a custom SaeboFlex orthosis as an inpatient at Riverview&#xD;
             Health Centre after having met the active and passive movement criteria required to&#xD;
             use the SaeboFlex orthosis&#xD;
&#xD;
          -  referred to outpatient Occupational Therapy at the Health Sciences Centre (Winnipeg,&#xD;
             Canada) for ongoing upper extremity rehabilitation using a SaeboFlex orthosis&#xD;
&#xD;
          -  able to commit to the time requirements of the study&#xD;
&#xD;
          -  have a premorbid fully functional upper extremity&#xD;
&#xD;
          -  able to speak and understand English&#xD;
&#xD;
          -  able to follow multistep commands and understand the purpose and required use of the&#xD;
             orthosis&#xD;
&#xD;
          -  able to stand for at least 10 minutes&#xD;
&#xD;
          -  have 3 times per week access to a caregiver to assist with donning the orthosis at&#xD;
             home if required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chedoke McMaster Stroke Assessment, Impairment Inventory (Shoulder Pain section) score&#xD;
             of 1-3&#xD;
&#xD;
          -  score of 3 or more on the Modified Ashworth Scale for elbow, wrist or finger flexors&#xD;
&#xD;
          -  swan neck deformities or contractures of the fingers or wrist of the paretic upper&#xD;
             extremity&#xD;
&#xD;
          -  history of skin breakdown on the paretic upper extremity or a score of less than 6 out&#xD;
             of 12 on the Sensation Section of the Fugl-Meyer Upper Extremity Assessment&#xD;
&#xD;
          -  significant cognitive impairment as determined by a score of 21 or less on the&#xD;
             Montreal Cognitive Assessment&#xD;
&#xD;
          -  able to fully extend fingers 10 times in a position of maximal shoulder flexion and&#xD;
             elbow extension with a neutral wrist&#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>Brenda L Semenko, BMR (OT)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.</citation>
    <PMID>20424192</PMID>
  </reference>
  <reference>
    <citation>Waddell KJ, Birkenmeier RL, Moore JL, Hornby TG, Lang CE. Feasibility of high-repetition, task-specific training for individuals with upper-extremity paresis. Am J Occup Ther. 2014 Jul-Aug;68(4):444-53. doi: 10.5014/ajot.2014.011619.</citation>
    <PMID>25005508</PMID>
  </reference>
  <reference>
    <citation>Butler A, Blanton S, Rowe V, Wolf S. Attempting to improve function and quality of life using the FTM Protocol: case report. J Neurol Phys Ther. 2006 Sep;30(3):148-56. doi: 10.1097/01.npt.0000281952.93934.6b.</citation>
    <PMID>17029658</PMID>
  </reference>
  <reference>
    <citation>Legg L, Langhorne P; Outpatient Service Trialists. Rehabilitation therapy services for stroke patients living at home: systematic review of randomised trials. Lancet. 2004 Jan 31;363(9406):352-6. doi: 10.1016/S0140-6736(04)15434-2.</citation>
    <PMID>15070563</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 29, 2017</last_update_submitted>
  <last_update_submitted_qc>November 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>upper extremity</keyword>
  <keyword>orthosis</keyword>
  <keyword>SaeboFlex</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>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/NCT02969967
org study id: H2016:285
nct id: NCT02969967
lead sponsor: 
has dmc: No
The purpose of this study is to explore the effectiveness of the SaeboFlex orthosis in
      improving upper extremity recovery for people in the early phases of rehabilitation post
      stroke. The objectives of the study are:

        1. to explore the effectiveness of the SaeboFlex orthosis in improving upper extremity
           function, strength, movement, spasticity and self-perceived occupational performance, in
           addition to conventional therapy, with continued use immediately after discharge from
           inpatient stroke rehabilitation and while waiting for outpatient occupational therapy
           services

        2. to explore the relationship between the participants' level of self-efficacy and use of
           the SaeboFlex orthosis in the home environment

        3. to explore the participants' experience of use of the SaeboFlex orthosis in the home
           environment.
Although intensive and repetitive use of the paretic upper extremity has been shown to
      improve upper extremity outcomes post stroke, few therapeutic approaches allow those with
      moderate to severe upper extremity impairment to independently participate in repetitive
      grasp and release activities. The SaeboFlex orthosis is a dynamic wrist-hand orthosis that
      assists with finger and thumb extension after functional grasping with the paretic hand and
      therefore may allow those with more affected upper extremities post stroke to participate in
      repetitive grasp and release activities that they otherwise would be unable to do. More
      research is required on the effectiveness of this orthosis in improving upper extremity
      recovery post stroke especially when used at home as a continuation of therapy received
      during inpatient rehabilitation. It has been suggested that guided home rehabilitation
      programs can improve the ability of stroke survivors to be more independent in their
      activities of daily living. This study is a mixed methods study combining a quantitative
      single subject ABA design and qualitative post study individual interviews to first capture
      quantitative information on the effectiveness of the SaeboFlex intervention and then
      qualitative information that will build on and further explain the quantitative data. Three
      participants who are using a SaeboFlex orthosis as part of their upper extremity
      rehabilitation program will be recruited from an inpatient stroke rehabilitation unit as they
      are being discharged from inpatient rehabilitation and will be seen by the principal
      investigator in their homes for 1 hour 3 times a week for 2 weeks and then once a week for 6
      weeks while they are on the waiting list for outpatient occupational therapy services. The
      intervention will follow a set protocol of grasp-release activities using the SaeboFlex
      orthosis for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release
      activities without the orthosis, both of which will be graded to provide optimal upper
      extremity challenge throughout the intervention period. Repeated baseline assessments will be
      completed by a trained research assistant, in the participants' homes, within one week of
      discharge from inpatient stroke rehabilitation and will be repeated after 4 and 8 weeks of
      intervention, followed by individual interviews in the participants' homes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Arm Activity Measure (ArmA)
time frame: Change from baseline upper extremity function to 4 and 8 weeks
description: The Arm Activity Measure (ArmA) is a self-report tool designed for use with upper extremity spasticity management interventions. The ArmA was chosen because it provides a comprehensive assessment at the activity level of both active and passive upper extremity function; it is comprised of an 8 item passive function subscale and a 13 item active function subscale. Both subscales have been found to have high internal consistency and test-retest reliability.
measure: Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7)
time frame: Change from baseline upper extremity function to 4 and 8 weeks
description: The Chedoke Arm and Hand Activity Inventory-7 (CAHAI-7) is a commonly used upper extremity functional assessment post stroke. It is comprised of seven bilateral functional tasks and has been found to have excellent test-retest and inter-rater reliability as well as internal consistency.
measure: Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
time frame: Change from baseline upper extremity impairment to 4 and 8 weeks
description: The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a widely used measure of motor impairment post stroke and is comprised of 33 items related to upper extremity movement. The FMA-UE has excellent inter-rater and test-retest reliability as well as construct validity in persons with stroke.
measure: Stroke Impact Scale (SIS)
time frame: Change from baseline perception of recovery to 4 and 8 weeks
description: The Stroke Impact Scale (SIS) is a well known and well studied measure of stroke survivors' perception of their recovery post stroke. The SIS has been widely used in stroke intervention studies.
measure: Modified Ashworth Scale (MAS)
time frame: Change from baseline spasticity to 4 and 8 weeks
description: The Modified Ashworth Scale (MAS) is a well known measure of spasticity post stroke. The MAS assesses the resistance to passive muscle stretch and is graded on a 6 point ordinal scale. The participants' elbow, wrist and finger flexors will be assessed with the MAS.
measure: Hand Grip Strength (measured using dynamometry)
time frame: Change from baseline grip strength to 4 and 8 weeks
description: Measurement of hand grip strength using dynamometry is common post stroke and has excellent test-retest and inter-rater reliability. An average of 3 grip strength trials will be taken at each measurement point using dynamometry.
measure: Stroke Self-Efficacy Questionnaire (SSEQ)
time frame: Change from baseline self-efficacy to 4 and 8 weeks
description: The Stroke Self-Efficacy Questionnaire (SSEQ) was designed to assess self-efficacy related to functional performance and self-management post stroke. The SSEQ is comprised of two subscales that are scored separately and correlate strongly with other measures of self-efficacy post stroke.
measure: Canadian Occupational Performance Measure (COPM)
time frame: Change from baseline perception of occupational performance to 4 and 8 weeks
description: The Canadian Occupational Performance Measure (COPM) is a valid and responsive measure of occupational performance and has been widely used in stroke research. The COPM uses a semi-structured interview format where performance and satisfaction scores will be identified for the participants' self-identified occupational performance issues.
measure: Individual interviews
time frame: 8 weeks
description: Individual interviews will be conducted at 8 weeks, after the intervention is complete, to generate discussion about the perceived usability of the SaeboFlex orthosis in the home environment, the perceived effect on upper extremity recovery as well as the perceived relationship between self-efficacy and use of the SaeboFlex orthosis in the home environment.
arm group label: SaeboFlex
arm group type: Experimental
description: Use of the SaeboFlex orthosis for a set protocol of grasp-release activities
intervention type: Device
intervention name: SaeboFlex
description: Use of the SaeboFlex orthosis for a set protocol of grasp-release activities for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis for 8 weeks. Will occur in participants' homes after discharge from inpatient rehabilitation with visit from principal investigator to progress program for 1 hour 3 times a week for the first 2 weeks and then once a week for 6 weeks.
arm group label: SaeboFlex
other name: functional dynamic orthosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brenda L Semenko, BMR (OT)
role: Principal Investigator
affiliation: University of Manitoba
facility: 
country: Canada
citation: Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.
PMID: 20424192
citation: Waddell KJ, Birkenmeier RL, Moore JL, Hornby TG, Lang CE. Feasibility of high-repetition, task-specific training for individuals with upper-extremity paresis. Am J Occup Ther. 2014 Jul-Aug;68(4):444-53. doi: 10.5014/ajot.2014.011619.
PMID: 25005508
citation: Butler A, Blanton S, Rowe V, Wolf S. Attempting to improve function and quality of life using the FTM Protocol: case report. J Neurol Phys Ther. 2006 Sep;30(3):148-56. doi: 10.1097/01.npt.0000281952.93934.6b.
PMID: 17029658
citation: Legg L, Langhorne P; Outpatient Service Trialists. Rehabilitation therapy services for stroke patients living at home: systematic review of randomised trials. Lancet. 2004 Jan 31;363(9406):352-6. doi: 10.1016/S0140-6736(04)15434-2.
PMID: 15070563
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No