<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/NCT03814889</url>
  </required_header>
  <id_info>
    <org_study_id>49330</org_study_id>
    <nct_id>NCT03814889</nct_id>
  </id_info>
  <brief_title>Passive Tactile Stimulation for Stroke Rehabilitation</brief_title>
  <acronym>PTS</acronym>
  <official_title>Passive Tactile Stimulation for Stroke Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is&#xD;
      to optimize the design of gentle vibratory stimulation delivered to the hands of individuals&#xD;
      with chronic stroke, and explore the effect on range of movement and spasticity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 15, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Modified Ashworth at 12 weeks</measure>
    <time_frame>Change from Baseline Modified Ashworth at 12 weeks</time_frame>
    <description>Modified Ashworth Scale for Spasticity (upper limb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Modified Ashworth at 8 weeks</measure>
    <time_frame>Change from Baseline Modified Ashworth at 8 weeks</time_frame>
    <description>Modified Ashworth Scale for Spasticity (upper limb)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Range of Motion at 12 weeks</measure>
    <time_frame>Change from Baseline Range of Motion at 12 weeks</time_frame>
    <description>Workspace of voluntary movement of arm will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Range of Motion at 8 weeks</measure>
    <time_frame>Change from Baseline Range of Motion at 8 weeks</time_frame>
    <description>Workspace of voluntary movement of arm will be measured</description>
  </primary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Stroke</condition>
  <condition>Stroke, Ischemic</condition>
  <condition>Stroke Hemorrhagic</condition>
  <condition>Spasticity as Sequela of Stroke</condition>
  <arm_group>
    <arm_group_label>Vibration pattern 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration pattern 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration pattern 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration pattern 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration pattern 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration pattern 6</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration pattern 7</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration pattern 8</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration pattern 9</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibration pattern 10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No vibration</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A light will blink instead of a vibration pattern being displayed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibration pattern</intervention_name>
    <description>PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial.&#xD;
Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.&#xD;
PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested.&#xD;
PHASE 4: This study takes 3 or 6 months. 1) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.</description>
    <arm_group_label>Vibration pattern 1</arm_group_label>
    <arm_group_label>Vibration pattern 10</arm_group_label>
    <arm_group_label>Vibration pattern 2</arm_group_label>
    <arm_group_label>Vibration pattern 3</arm_group_label>
    <arm_group_label>Vibration pattern 4</arm_group_label>
    <arm_group_label>Vibration pattern 5</arm_group_label>
    <arm_group_label>Vibration pattern 6</arm_group_label>
    <arm_group_label>Vibration pattern 7</arm_group_label>
    <arm_group_label>Vibration pattern 8</arm_group_label>
    <arm_group_label>Vibration pattern 9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>No vibration</intervention_name>
    <description>These patients will wear a glove with a blinking light instead of feeling vibrations.</description>
    <arm_group_label>No vibration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and older.&#xD;
&#xD;
          -  diagnosis of stroke with upper extremity spasticity or other movement deficits that&#xD;
             affect strength and range of movement.&#xD;
&#xD;
          -  willing to participate in the vibrotactile stimulation sessions for consecutive days&#xD;
             and willing to return for follow up visits as needed for the PHASE in progress.&#xD;
&#xD;
          -  able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.&#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>Allison M Okamura, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Neuroscience Health Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Allison Okamura</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>spasticity</keyword>
  <keyword>tone</keyword>
  <keyword>hemiplegia</keyword>
  <keyword>hemiparesis</keyword>
  <keyword>arm</keyword>
  <keyword>hand</keyword>
  <keyword>vibration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 26, 2022</submitted>
    <submission_canceled>August 27, 2022</submission_canceled>
    <submitted>August 29, 2022</submitted>
    <returned>July 24, 2023</returned>
    <submitted>August 14, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03814889
org study id: 49330
nct id: NCT03814889
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is
      to optimize the design of gentle vibratory stimulation delivered to the hands of individuals
      with chronic stroke, and explore the effect on range of movement and spasticity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Modified Ashworth at 12 weeks
time frame: Change from Baseline Modified Ashworth at 12 weeks
description: Modified Ashworth Scale for Spasticity (upper limb)
measure: Change in Modified Ashworth at 8 weeks
time frame: Change from Baseline Modified Ashworth at 8 weeks
description: Modified Ashworth Scale for Spasticity (upper limb)
measure: Change in Range of Motion at 12 weeks
time frame: Change from Baseline Range of Motion at 12 weeks
description: Workspace of voluntary movement of arm will be measured
measure: Change in Range of Motion at 8 weeks
time frame: Change from Baseline Range of Motion at 8 weeks
description: Workspace of voluntary movement of arm will be measured
arm group label: Vibration pattern 1
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: Vibration pattern 2
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: Vibration pattern 3
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: Vibration pattern 4
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: Vibration pattern 5
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: Vibration pattern 6
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: Vibration pattern 7
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: Vibration pattern 8
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: Vibration pattern 9
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: Vibration pattern 10
arm group type: Active Comparator
description: Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
arm group label: No vibration
arm group type: Placebo Comparator
description: A light will blink instead of a vibration pattern being displayed.
intervention type: Device
intervention name: Vibration pattern
description: PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial.
Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.
PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested.
PHASE 4: This study takes 3 or 6 months. 1) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
arm group label: Vibration pattern 1
arm group label: Vibration pattern 10
arm group label: Vibration pattern 2
arm group label: Vibration pattern 3
arm group label: Vibration pattern 4
arm group label: Vibration pattern 5
arm group label: Vibration pattern 6
arm group label: Vibration pattern 7
arm group label: Vibration pattern 8
arm group label: Vibration pattern 9
intervention type: Device
intervention name: No vibration
description: These patients will wear a glove with a blinking light instead of feeling vibrations.
arm group label: No vibration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Allison M Okamura, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Allison Okamura
investigator title: Professor
mesh term: Muscle Spasticity
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Hemorrhagic Stroke
sharing ipd: Undecided
submitted: August 26, 2022
submission canceled: August 27, 2022
submitted: August 29, 2022
returned: July 24, 2023
submitted: August 14, 2023