<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/NCT04488250</url>
  </required_header>
  <id_info>
    <org_study_id>826195</org_study_id>
    <nct_id>NCT04488250</nct_id>
  </id_info>
  <brief_title>Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana</brief_title>
  <official_title>Robot-Assisted Rehabilitation After HIV-Associated Stroke: Botswana</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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>
      Today, nearly 37 million people are living with HIV (PLHIV) worldwide and 30 to 40% of them&#xD;
      will have neurologic complications leading to disability. Our long-term working hypothesis is&#xD;
      that an effective solution for increasing rehabilitation access in Botswana and improving&#xD;
      functional outcomes of PLHIV having experienced a stroke with or without HIV uses an&#xD;
      affordable robot and mobile health technologies to create a cost-effective intervention&#xD;
      strategy. For this project, we test the feasibility of affordable robot therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will test the feasibility of affordable robot therapy in three Aims. In Aim 1, we will&#xD;
      optimize for the Botswana context, an affordable technology-based robot system with four&#xD;
      exercise stations. We will optimize a prototype of our provisionally patented robot gym&#xD;
      system, REHAB CARES, for therapy. Optimization will include increasing cost-effectiveness,&#xD;
      utilizing more local resources and manufacturing, and using mobile health android platforms&#xD;
      for games and data acquisition. In Aim 2, the efficiency of the newly modified robot system&#xD;
      compared to standard of care will be assessed using 30 patients who have experienced a&#xD;
      stroke, with or without HIV, will be recruited from those who are being treated by Princess&#xD;
      Marina Hospital (PMH) and living in the surrounding community. They will receive therapy&#xD;
      using the robot gym system and receive standard of care. We will assess functional outcomes&#xD;
      including motor impairment, function, and quality of life. The study outcomes would then&#xD;
      inform rehabilitation practices for PLHIV with stroke, with or without HIV, and suggest that&#xD;
      affordable technology-mediated rehabilitation can reduce their motor dysfunction and&#xD;
      resulting long-term disability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Low-to-mid functioning HIV/AIDS patients with stroke co-morbidity. Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified IBM Usability Satisfaction Questionnaire</measure>
    <time_frame>At 8 Weeks</time_frame>
    <description>Assess usability of the robot system with patients and therapists</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline assessment of motor impairment</measure>
    <time_frame>At week 8</time_frame>
    <description>The Fugl-Meyer measure of motor impairment in the upper limb. Max is 66. Min 0; higher is better. up to 30 minutes to complete</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rehabilitation Capacity Questionnaire</measure>
    <time_frame>At 0 week</time_frame>
    <description>Survey for all therapists and rehab professionals - up to 1 hour; interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline assessment of Timed up and go</measure>
    <time_frame>at 8 weeks</time_frame>
    <description>Timed up and go - Measure gait capacity. Measured is minutes. Longer times indicate higher impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline assessment of 10 Meter Walk Test</measure>
    <time_frame>at 8 weeks</time_frame>
    <description>Measure gait distance capacity. Measured in meters. Longer distance means lower impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline assessment of # of blocks that can be grasped and moved</measure>
    <time_frame>at 8 weeks</time_frame>
    <description>Box and Block Test is a reach and grasp test - gross motor function. Measured in # of blocks. Higher number of blocks means lower impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline assessment of fine motor grasp</measure>
    <time_frame>at 8 weeks</time_frame>
    <description>Grooved Peg-Board Test is measure of fine motor grasp. Measured in times and number of pins placed. More pins placed means lower impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline assessment of stroke impact scale</measure>
    <time_frame>at 8 weeks</time_frame>
    <description>quality of life questionnaire; self-reported. The Stroke Impact Scale (SIS) assesses other dimensions of health related quality of life: emotion, communication, memory and thinking, and social role function. Higher scores means less impaired. Lower score is more impaired.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Low-to-mid functioning HIV/AIDS patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Low-to-mid functioning HIV/AIDS patients greater than 18 years of age with stroke co-morbidity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stroke survivors</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Robot Therapy</intervention_name>
    <description>Robot Therapy</description>
    <arm_group_label>Low-to-mid functioning HIV/AIDS patients</arm_group_label>
    <arm_group_label>Stroke survivors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of Stroke (at least 3 months post incident) with or without HIV, age over&#xD;
             18;&#xD;
&#xD;
          -  medically stable (Able to tolerate therapy and given the determination as able to go&#xD;
             through protocol by physician);&#xD;
&#xD;
          -  have neurological function between 5 and 24 as defined by the NIH Stroke Scale&#xD;
             (NIHSS);&#xD;
&#xD;
          -  have no less than moderate cognitive function as defined by the International&#xD;
             HIV-Dementia Scale&#xD;
&#xD;
          -  Able to give consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to give consent;&#xD;
&#xD;
          -  severely depressed (Becks Depression Inventory-Fast Screener);&#xD;
&#xD;
          -  experiencing excessive pain (Visual Analog Scale (VAS) score greater than 4);&#xD;
&#xD;
          -  have severe spasticity ( than 3) in muscle tone in elbow/shoulder/wrist hip/knee/ankle&#xD;
             using the Ashworth Scale;&#xD;
&#xD;
          -  have total paralysis or muscular contractures of upper or lower extremity;&#xD;
&#xD;
          -  have a history of psychiatric disorder or cardiac problems;&#xD;
&#xD;
          -  have a history of prior brain injury including lesions to the cerebella or brain stem;&#xD;
&#xD;
          -  have open lesions on the upper or lower limbs;&#xD;
&#xD;
          -  It is up to the physician to decide if a subject should be excluded due to severe drug&#xD;
             and/or alcohol abuse or taking of medication that would impair cognitive ability.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle J Johnson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michelle Johnson, PhD</last_name>
    <phone>2158932665</phone>
    <email>johnmic@pennmedicine.upenn.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Penn Medicine Rittenhouse</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19146</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Botswana</name>
      <address>
        <city>Gaborone</city>
        <country>Botswana</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maikutlo Kebaetse, PhD</last_name>
      <phone>267-355-4606</phone>
    </contact>
  </location>
  <location_countries>
    <country>Botswana</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>April 30, 2019</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>December 1, 2022</last_update_submitted>
  <last_update_submitted_qc>December 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</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>
  <!-- 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/NCT04488250
org study id: 826195
nct id: NCT04488250
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Today, nearly 37 million people are living with HIV (PLHIV) worldwide and 30 to 40% of them
      will have neurologic complications leading to disability. Our long-term working hypothesis is
      that an effective solution for increasing rehabilitation access in Botswana and improving
      functional outcomes of PLHIV having experienced a stroke with or without HIV uses an
      affordable robot and mobile health technologies to create a cost-effective intervention
      strategy. For this project, we test the feasibility of affordable robot therapy.
We will test the feasibility of affordable robot therapy in three Aims. In Aim 1, we will
      optimize for the Botswana context, an affordable technology-based robot system with four
      exercise stations. We will optimize a prototype of our provisionally patented robot gym
      system, REHAB CARES, for therapy. Optimization will include increasing cost-effectiveness,
      utilizing more local resources and manufacturing, and using mobile health android platforms
      for games and data acquisition. In Aim 2, the efficiency of the newly modified robot system
      compared to standard of care will be assessed using 30 patients who have experienced a
      stroke, with or without HIV, will be recruited from those who are being treated by Princess
      Marina Hospital (PMH) and living in the surrounding community. They will receive therapy
      using the robot gym system and receive standard of care. We will assess functional outcomes
      including motor impairment, function, and quality of life. The study outcomes would then
      inform rehabilitation practices for PLHIV with stroke, with or without HIV, and suggest that
      affordable technology-mediated rehabilitation can reduce their motor dysfunction and
      resulting long-term disability.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: Low-to-mid functioning HIV/AIDS patients with stroke co-morbidity. Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS.
primary purpose: Other
masking: None (Open Label)
measure: Modified IBM Usability Satisfaction Questionnaire
time frame: At 8 Weeks
description: Assess usability of the robot system with patients and therapists
measure: Change in Baseline assessment of motor impairment
time frame: At week 8
description: The Fugl-Meyer measure of motor impairment in the upper limb. Max is 66. Min 0; higher is better. up to 30 minutes to complete
measure: Rehabilitation Capacity Questionnaire
time frame: At 0 week
description: Survey for all therapists and rehab professionals - up to 1 hour; interview
measure: Change from baseline assessment of Timed up and go
time frame: at 8 weeks
description: Timed up and go - Measure gait capacity. Measured is minutes. Longer times indicate higher impairment.
measure: Change from baseline assessment of 10 Meter Walk Test
time frame: at 8 weeks
description: Measure gait distance capacity. Measured in meters. Longer distance means lower impairment.
measure: Change from baseline assessment of # of blocks that can be grasped and moved
time frame: at 8 weeks
description: Box and Block Test is a reach and grasp test - gross motor function. Measured in # of blocks. Higher number of blocks means lower impairment.
measure: Change from baseline assessment of fine motor grasp
time frame: at 8 weeks
description: Grooved Peg-Board Test is measure of fine motor grasp. Measured in times and number of pins placed. More pins placed means lower impairment.
measure: Change from baseline assessment of stroke impact scale
time frame: at 8 weeks
description: quality of life questionnaire; self-reported. The Stroke Impact Scale (SIS) assesses other dimensions of health related quality of life: emotion, communication, memory and thinking, and social role function. Higher scores means less impaired. Lower score is more impaired.
arm group label: Low-to-mid functioning HIV/AIDS patients
arm group type: Other
description: Low-to-mid functioning HIV/AIDS patients greater than 18 years of age with stroke co-morbidity.
arm group label: Stroke survivors
arm group type: Other
description: Stroke survivors greater than 18 years of age with hemiplegia with and without HIV/AIDS.
intervention type: Other
intervention name: Robot Therapy
description: Robot Therapy
arm group label: Low-to-mid functioning HIV/AIDS patients
arm group label: Stroke survivors
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Michelle J Johnson, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Michelle Johnson, PhD
phone: 2158932665
email: johnmic@pennmedicine.upenn.edu
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
country: Botswana
country: United States
responsible party type: Sponsor
mesh term: Stroke