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/NCT05965713</url>
    </required_header>
    <id_info>
      <org_study_id>National Remote IpsiHand Study</org_study_id>
      <nct_id>NCT05965713</nct_id>
    </id_info>
    <brief_title>National Fully Remote Use of IpsiHand Device in Hemiparetic Stroke</brief_title>
    <official_title>IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Neurolutions, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Neurolutions, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to define the efficacy of fully remote home-based BCI therapy in&#xD;
        chronic hemiparetic subcortical stroke patients. A randomized controlled study using the&#xD;
        integrated remote BCI system will be tested against standard exercise therapy to determine&#xD;
        the efficacy of motor improvement in chronic stroke patients with an upper extremity&#xD;
        hemiparesis. Specifically, the integrated BCI system will include 1) the remote screening and&#xD;
        motor assessment system for the upper extremity and 2) the BCI-controlled robotic hand&#xD;
        exoskeleton (i.e. IpsiHand).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The ultimate goal of this project is to develop a functioning and clinically feasible method&#xD;
        for restoring function to motor impaired stroke survivors. This ultimate goal is to develop a&#xD;
        system that allows for enhanced functional capability and works consistently over a long-term&#xD;
        basis and is accessible remotely no matter location or access to healthcare. In developing a&#xD;
        new rehabilitation method, the researchers hope to create a system that allows for closed&#xD;
        loop feedback through a robotic hand orthosis on the motor impaired side of stroke patients&#xD;
        in response to intended movements of the muscles. The method, if successful, would represent&#xD;
        an ideal, non-invasive method of promoting motor learning and recovery in stroke survivors.&#xD;
        The ability to operate robotic hand orthosis using electrical signals of the brain is rapidly&#xD;
        leaving the realm of science fiction and becoming a realistic goal of the clinical community.&#xD;
        The current advances in BCI controlled neuroprosthetics could have immeasurable influence on&#xD;
        adult patients with severe motor impairments from stroke. Even further on the horizon the&#xD;
        insights developed from such work could substantively alter the way all stroke patients are&#xD;
        treated and rehabilitated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 10, 2025</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>
      <intervention_model_description>Study staff will screen participants virtually or in person for eligibility after completing the informed consent process and documentation. After screening for study eligibility has occurred, the initial EEG screening will take place for all individuals who meet the criteria for the study as to ensure no preference to subjects with optimal signals for use of the IpsiHand. Once EEG screenings have been completed, the participant will be randomly assigned to Group 1 (BCI treatment) or Group 2 (standard of care treatment group). Each group will complete a daily therapy regimen. In Group 1 (BCI group)- will complete daily BCI therapy. In Group 2 (standard of care)- individuals will complete standard of care therapy program daily for 12 weeks provided by an occupational therapist.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Upper Extremity Remote Fugl-Meyer</measure>
      <time_frame>Baseline assessment</time_frame>
      <description>Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Upper Extremity Remote Fugl-Meyer</measure>
      <time_frame>2 week assessment</time_frame>
      <description>Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Upper Extremity Remote Fugl-Meyer</measure>
      <time_frame>4 week assessment</time_frame>
      <description>Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Upper Extremity Remote Fugl-Meyer</measure>
      <time_frame>6 week assessment</time_frame>
      <description>Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Upper Extremity Remote Fugl-Meyer</measure>
      <time_frame>8 week assessment</time_frame>
      <description>Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Upper Extremity Remote Fugl-Meyer</measure>
      <time_frame>10 week assessment</time_frame>
      <description>Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Upper Extremity Remote Fugl-Meyer</measure>
      <time_frame>12 week assessment (outcome assessment)</time_frame>
      <description>Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Motor Activity Log</measure>
      <time_frame>Baseline assessment</time_frame>
      <description>Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score= 140</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motor Activity Log</measure>
      <time_frame>12 week completion</time_frame>
      <description>Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score=140</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gross Grasp Strength</measure>
      <time_frame>Baseline assessment</time_frame>
      <description>Evaluation of gross grasp strength via dynamometry; lowest score=0 lbs, maximal score 150lbs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gross Grasp Strength</measure>
      <time_frame>12 week completion</time_frame>
      <description>Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Stroke</condition>
    <condition>Hemiparesis</condition>
    <condition>Spasticity as Sequela of Stroke</condition>
    <condition>Brain Computer Interface</condition>
    <arm_group>
      <arm_group_label>BCI treatment Group using the IpsiHand</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Subjects will undergo an EEG screening protocol to ensure that a consistent control signal will be present to control the IpsiHand device. After an EEG screening session is complete, the participants screening data will be analyzed to ensure that sufficient cortical signals are present. Randomization for assignment to group 1 or 2 will then occur. Once assigned to group 1, if consistent signals are found, the participant will then continue to Phase 2.&#xD;
  Phase 2: Group 1 subjects will be provided with a Neurolutions IpsiHand BCI system, which combines a novel powered exoskeleton with a commercial EEG amplifier and active electrode system. The exoskeleton opens and closes the patient's hand in a three-finger pinch grip. Patients will use the BCI system on a minimum of 5 days per week for 12 weeks. Patients will complete five or more 10-minute runs of the BCI task per day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care - Home Exercise Program for Upper Extremity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Once randomized, the participant will be assigned to group 2 to begin standard of care treatment at home.&#xD;
  Phase 2: After being assigned to Group 2, subjects will serve as the control group in the study. Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks to control for the non-specific motor and sensory effects of BCI training. To help ensure compliance with the at-home portion of the protocol in the control group, participants will receive daily virtual monitoring from the study clinical specialist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Neurolutions IpsiHand System</intervention_name>
      <description>The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.</description>
      <arm_group_label>BCI treatment Group using the IpsiHand</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard of Care - Home Exercise Program for Upper Extremity</intervention_name>
      <description>Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks</description>
      <arm_group_label>Standard of Care - Home Exercise Program for Upper Extremity</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults age (18-85)&#xD;
  &#xD;
            2. Adults who sustained a CVA&#xD;
  &#xD;
            3. Have upper extremity hemiparesis/hemiplegia&#xD;
  &#xD;
            4. Participants who are not receiving Botox Injections for the upper extremity may be&#xD;
               included. Should a participant be receiving Botox injections for the upper extremity,&#xD;
               they may be included but Botox administration must be timed to coincide within a week&#xD;
               of the beginning of training.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants who are not receiving Botox Injections for the upper extremity may be&#xD;
               included. Should a participant be receiving Botox injections for the upper extremity,&#xD;
               they may be included but Botox administration must be timed to coincide within a week&#xD;
               of the beginning of training.&#xD;
  &#xD;
            2. Participants who are too cognitively impaired to understand the task or provide&#xD;
               informed consent will be excluded. A Short-Blessed Test score of 8 or more will be&#xD;
               excluded.&#xD;
  &#xD;
            3. Participants who have contractures in the affected wrist and digits will be excluded,&#xD;
               as the device will not comfortably fit.&#xD;
  &#xD;
            4. Participants who have receptive aphasia and unable to follow written directions will&#xD;
               be excluded. A score of 6 or less on the MS Aphasia Screening Test will be excluded.&#xD;
  &#xD;
            5. Participants receiving any formal upper extremity therapy will be excluded.&#xD;
  &#xD;
            6. Participants with ataxia apraxia or severe psychiatric illness (other than post stroke&#xD;
               depression) will be excluded.&#xD;
  &#xD;
            7. Participants who are pregnant or breast-feeding will be excluded.&#xD;
  &#xD;
            8. Participants who have nerve or sensory impairment that may limit or interfere with&#xD;
               their ability to sense pain will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kelly Carr, MOT, OTR/L</last_name>
      <phone>314-272-2575</phone>
      <email>kcarr@neurolutions.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lauren Souders, MOT, OTR/L</last_name>
      <phone>314-272-2575</phone>
      <email>lauren@neurolutions.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Neurolutions</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://academic.oup.com/braincomms/article/4/3/fcac136/6591904?guestAccessKey=e52570be-8afa-4b87-9136-570b2adcfb60&amp;login=false</url>
      <description>Theta-gamma coupling as a cortical biomarker of brain-computer interface-mediated motor recovery in chronic stroke</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/15839599/</url>
      <description>A variables associated with occupational and physical therapy stroke rehabilitation utilization and outcomes</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/28835194/</url>
      <description>Inequities in access to inpatient rehabilitation after stroke: an international scoping review</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/15843670/</url>
      <description>Clinical practice. Rehabilitation after stroke</description>
    </link>
    <link>
      <url>http://koreascience.or.kr/article/JAKO201319133640292.page</url>
      <description>Brain-Computer Interface in Stroke Rehabilitation</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/18258825/</url>
      <description>Think to move: a neuromagnetic brain-computer interface (BCI) system for chronic stroke</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/20208465/</url>
      <description>Feasibility of a new application of noninvasive Brain Computer Interface (BCI): a case study of training for recovery of volitional motor control after stroke</description>
    </link>
    <link>
      <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4114185/</url>
      <description>Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/16235812/</url>
      <description>An evaluation framework for a rural home-based telerehabilitation network</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/19169175/</url>
      <description>Disparities in postacute stroke rehabilitation disposition to acute inpatient rehabilitation vs. home: findings from the North Carolina Hospital Discharge Database</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/10916961/</url>
      <description>Barriers to care among racial/ethnic groups under managed care</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/20542850/</url>
      <description>Stroke patients' and carers' perception of barriers to accessing stroke information</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/23738231/</url>
      <description>Rehabilitation with poststroke motor recovery: a review with a focus on neural plasticity</description>
    </link>
    <link>
      <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4083225/</url>
      <description>Brain-computer interface with somatosensory feedback improves functional recovery from severe hemiplegia due to chronic stroke</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/24590225/</url>
      <description>Efficacy of brain-computer interface-driven neuromuscular electrical stimulation for chronic paresis after stroke</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Neurolutions</keyword>
    <keyword>IpsiHand</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Paresis</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/NCT05965713
  org study id: National Remote IpsiHand Study
  nct id: NCT05965713
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The goal of this study is to define the efficacy of fully remote home-based BCI therapy in
        chronic hemiparetic subcortical stroke patients. A randomized controlled study using the
        integrated remote BCI system will be tested against standard exercise therapy to determine
        the efficacy of motor improvement in chronic stroke patients with an upper extremity
        hemiparesis. Specifically, the integrated BCI system will include 1) the remote screening and
        motor assessment system for the upper extremity and 2) the BCI-controlled robotic hand
        exoskeleton (i.e. IpsiHand).
  The ultimate goal of this project is to develop a functioning and clinically feasible method
        for restoring function to motor impaired stroke survivors. This ultimate goal is to develop a
        system that allows for enhanced functional capability and works consistently over a long-term
        basis and is accessible remotely no matter location or access to healthcare. In developing a
        new rehabilitation method, the researchers hope to create a system that allows for closed
        loop feedback through a robotic hand orthosis on the motor impaired side of stroke patients
        in response to intended movements of the muscles. The method, if successful, would represent
        an ideal, non-invasive method of promoting motor learning and recovery in stroke survivors.
        The ability to operate robotic hand orthosis using electrical signals of the brain is rapidly
        leaving the realm of science fiction and becoming a realistic goal of the clinical community.
        The current advances in BCI controlled neuroprosthetics could have immeasurable influence on
        adult patients with severe motor impairments from stroke. Even further on the horizon the
        insights developed from such work could substantively alter the way all stroke patients are
        treated and rehabilitated.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Study staff will screen participants virtually or in person for eligibility after completing the informed consent process and documentation. After screening for study eligibility has occurred, the initial EEG screening will take place for all individuals who meet the criteria for the study as to ensure no preference to subjects with optimal signals for use of the IpsiHand. Once EEG screenings have been completed, the participant will be randomly assigned to Group 1 (BCI treatment) or Group 2 (standard of care treatment group). Each group will complete a daily therapy regimen. In Group 1 (BCI group)- will complete daily BCI therapy. In Group 2 (standard of care)- individuals will complete standard of care therapy program daily for 12 weeks provided by an occupational therapist.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Upper Extremity Remote Fugl-Meyer
  time frame: Baseline assessment
  description: Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
  measure: Upper Extremity Remote Fugl-Meyer
  time frame: 2 week assessment
  description: Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
  measure: Upper Extremity Remote Fugl-Meyer
  time frame: 4 week assessment
  description: Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
  measure: Upper Extremity Remote Fugl-Meyer
  time frame: 6 week assessment
  description: Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
  measure: Upper Extremity Remote Fugl-Meyer
  time frame: 8 week assessment
  description: Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
  measure: Upper Extremity Remote Fugl-Meyer
  time frame: 10 week assessment
  description: Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
  measure: Upper Extremity Remote Fugl-Meyer
  time frame: 12 week assessment (outcome assessment)
  description: Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
  measure: Motor Activity Log
  time frame: Baseline assessment
  description: Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score= 140
  measure: Motor Activity Log
  time frame: 12 week completion
  description: Subjective assessment of use of hemiparetic arm in daily activity following stroke; lowest score=0, highest score=140
  measure: Gross Grasp Strength
  time frame: Baseline assessment
  description: Evaluation of gross grasp strength via dynamometry; lowest score=0 lbs, maximal score 150lbs
  measure: Gross Grasp Strength
  time frame: 12 week completion
  description: Evaluation of gross grasp strength via dynamometry; lowest score= 0lbs, highest score =150lbs
  arm group label: BCI treatment Group using the IpsiHand
  arm group type: Experimental
  description: Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Subjects will undergo an EEG screening protocol to ensure that a consistent control signal will be present to control the IpsiHand device. After an EEG screening session is complete, the participants screening data will be analyzed to ensure that sufficient cortical signals are present. Randomization for assignment to group 1 or 2 will then occur. Once assigned to group 1, if consistent signals are found, the participant will then continue to Phase 2.
  Phase 2: Group 1 subjects will be provided with a Neurolutions IpsiHand BCI system, which combines a novel powered exoskeleton with a commercial EEG amplifier and active electrode system. The exoskeleton opens and closes the patient's hand in a three-finger pinch grip. Patients will use the BCI system on a minimum of 5 days per week for 12 weeks. Patients will complete five or more 10-minute runs of the BCI task per day.
  arm group label: Standard of Care - Home Exercise Program for Upper Extremity
  arm group type: Experimental
  description: Phase 1: Group 1 subjects will receive an IpsiHand Screening System to complete a remote EEG Screening. Once randomized, the participant will be assigned to group 2 to begin standard of care treatment at home.
  Phase 2: After being assigned to Group 2, subjects will serve as the control group in the study. Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks to control for the non-specific motor and sensory effects of BCI training. To help ensure compliance with the at-home portion of the protocol in the control group, participants will receive daily virtual monitoring from the study clinical specialist.
  intervention type: Device
  intervention name: Neurolutions IpsiHand System
  description: The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.
  arm group label: BCI treatment Group using the IpsiHand
  intervention type: Other
  intervention name: Standard of Care - Home Exercise Program for Upper Extremity
  description: Subjects will receive a customized home range of motion exercise program. Subjects will be recommended to complete their exercises daily, 5 out of 7 days per week for 12 weeks
  arm group label: Standard of Care - Home Exercise Program for Upper Extremity
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Kelly Carr, MOT, OTR/L
  phone: 314-272-2575
  email: kcarr@neurolutions.com
  last name: Lauren Souders, MOT, OTR/L
  phone: 314-272-2575
  email: lauren@neurolutions.com
  facility: 
  country: United States
  url: https://academic.oup.com/braincomms/article/4/3/fcac136/6591904?guestAccessKey=e52570be-8afa-4b87-9136-570b2adcfb60&login=false
  description: Theta-gamma coupling as a cortical biomarker of brain-computer interface-mediated motor recovery in chronic stroke
  url: https://pubmed.ncbi.nlm.nih.gov/15839599/
  description: A variables associated with occupational and physical therapy stroke rehabilitation utilization and outcomes
  url: https://pubmed.ncbi.nlm.nih.gov/28835194/
  description: Inequities in access to inpatient rehabilitation after stroke: an international scoping review
  url: https://pubmed.ncbi.nlm.nih.gov/15843670/
  description: Clinical practice. Rehabilitation after stroke
  url: http://koreascience.or.kr/article/JAKO201319133640292.page
  description: Brain-Computer Interface in Stroke Rehabilitation
  url: https://pubmed.ncbi.nlm.nih.gov/18258825/
  description: Think to move: a neuromagnetic brain-computer interface (BCI) system for chronic stroke
  url: https://pubmed.ncbi.nlm.nih.gov/20208465/
  description: Feasibility of a new application of noninvasive Brain Computer Interface (BCI): a case study of training for recovery of volitional motor control after stroke
  url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4114185/
  description: Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke
  url: https://pubmed.ncbi.nlm.nih.gov/16235812/
  description: An evaluation framework for a rural home-based telerehabilitation network
  url: https://pubmed.ncbi.nlm.nih.gov/19169175/
  description: Disparities in postacute stroke rehabilitation disposition to acute inpatient rehabilitation vs. home: findings from the North Carolina Hospital Discharge Database
  url: https://pubmed.ncbi.nlm.nih.gov/10916961/
  description: Barriers to care among racial/ethnic groups under managed care
  url: https://pubmed.ncbi.nlm.nih.gov/20542850/
  description: Stroke patients' and carers' perception of barriers to accessing stroke information
  url: https://pubmed.ncbi.nlm.nih.gov/23738231/
  description: Rehabilitation with poststroke motor recovery: a review with a focus on neural plasticity
  url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4083225/
  description: Brain-computer interface with somatosensory feedback improves functional recovery from severe hemiplegia due to chronic stroke
  url: https://pubmed.ncbi.nlm.nih.gov/24590225/
  description: Efficacy of brain-computer interface-driven neuromuscular electrical stimulation for chronic paresis after stroke
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Paresis
  sharing ipd: No