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/NCT06023316</url>
    </required_header>
    <id_info>
      <org_study_id>mGain-001</org_study_id>
      <nct_id>NCT06023316</nct_id>
    </id_info>
    <brief_title>mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation</brief_title>
    <official_title>mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Orthocare Innovations, LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Disability, Independent Living, and Rehabilitation Research</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Orthocare Innovations, LLC</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile&#xD;
        app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides&#xD;
        biofeedback-based therapy in individuals with upper limb weakness due to neurologic injury or&#xD;
        with upper limb amputation. Our overarching hypothesis is that the mGain wireless sEMG device&#xD;
        and mobile therapeutic gaming environment will demonstrate improved adherence to therapy when&#xD;
        compared to standard of care and will be feasible, acceptable, and usable in individuals with&#xD;
        upper limb weakness or limb amputation.&#xD;
  &#xD;
        All participants will undertake four weeks of therapy. Conducting therapy five days a week&#xD;
        for 30 minutes a day. In addition, participants will have an initial and final assessment&#xD;
        visit at a study site, with each visit expected to last 1-2 hours.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All participants will undertake four weeks of therapy. Conducting therapy five days a week&#xD;
        for 30 minutes a day. In addition, participants will have an initial and final assessment&#xD;
        visit at a study site, with each visit expected to last 1-2 hours.&#xD;
  &#xD;
        Initial Assessment: Eligible individuals will complete a baseline assessment including range&#xD;
        of motion, manual muscle testing, and handheld dynamometry of the target limb(s). Target&#xD;
        muscles for therapy will be identified (e.g., biceps, triceps, deltoids, forearm flexors,&#xD;
        forearm extensors) and a trial of sEMG evaluation to detect muscle signal will be conducted.&#xD;
        If detectable muscle signal is present, participants will complete the consent process and be&#xD;
        enrolled in the study. Each participant will be taught the use of the mGain system using&#xD;
        their own mobile phone or tablet and be given a therapeutic regimen to target their&#xD;
        individual muscle weakness. Participants will then be asked to demonstrate use of the system.&#xD;
        Participants can ask questions to ensure they understand system usage and the expectations&#xD;
        when at home. Participants will complete baseline validated outcome measures such as the&#xD;
        QuickDASH (Disabilities of the Arm, Shoulder and Hand questionnaire) and PROMIS Self-Efficacy&#xD;
        Scale.&#xD;
  &#xD;
        Home Therapy: For the four weeks following the initial assessment, participants will be asked&#xD;
        to conduct a minimum of 30 minutes of therapy per day, 5 days a week, at home using the mGain&#xD;
        system targeting the muscles identified during the initial assessment. Individuals will be&#xD;
        asked to complete short questionnaires and write in an eDiary about their experience after&#xD;
        conducting their daily exercises. A member of the study team will contact the participants on&#xD;
        a weekly basis to provide technical support, inquire about adherence, and encourage&#xD;
        participation. Data for each participant will be uploaded to Orthocare Innovations' HIPAA&#xD;
        compliant cloud-based server.&#xD;
  &#xD;
        Final Assessment: Participants will complete a final assessment of strength, range of motion,&#xD;
        and manual muscle testing. Additionally, participants will complete outcome measures and&#xD;
        surveys such as the QuickDASH, PROMIS Self-Efficacy, system usability scale, and a custom&#xD;
        feasibility survey.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pre Self-Efficacy</measure>
      <time_frame>At initial assessment before using intervention</time_frame>
      <description>The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post Self-Efficacy</measure>
      <time_frame>At final assessment after using intervention for four weeks</time_frame>
      <description>The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>System Usability Scale</measure>
      <time_frame>At final assessment after using intervention for four weeks</time_frame>
      <description>The System Usability Scale measures the usability of a system and is a 10-item questionnaire completed by the participant; results in score 0-100 where scores above 68 would be considered above average.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>pre-QuickDASH</measure>
      <time_frame>At initial assessment before using intervention</time_frame>
      <description>QuickDASH (Disabilities of the Arm, Shoulder and Hand) is a validated patient-reported questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb; results in score 0-100 where 0 represents the least disability and 100 represents the greatest disability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>post-QuickDASH</measure>
      <time_frame>At final assessment after using intervention for four weeks</time_frame>
      <description>QuickDASH is a validated patient-reported questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb; results in score 0-100 where 0 represents the least disability and 100 represents the greatest disability</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Upper Limb Weakness Due to Central Neurologic Injury</condition>
    <condition>Upper Limb Weakness Due to Peripheral Neurologic Injury</condition>
    <condition>Upper Limb Weakness Due to Nerve Reconstruction</condition>
    <condition>Upper Limb Weakness Due to Tendon Transfer Surgery</condition>
    <condition>Stroke</condition>
    <condition>Upper Limb Amputation</condition>
    <arm_group>
      <arm_group_label>mGain system</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>mGain system: passive, noninvasive, Bluetooth-enabled, wire-free, surface electromyography measurement device that provides input to a mobile app for an interactive gaming platform</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>mGain system</intervention_name>
      <description>passive, noninvasive surface electromyography measurement device and gaming mobile application</description>
      <arm_group_label>mGain system</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years or older&#xD;
  &#xD;
            -  Upper limb weakness due to central or peripheral neurologic injury, stroke, or nerve&#xD;
               reconstruction or tendon transfer surgery within one year; or upper limb amputation&#xD;
               (e.g., transradial or transhumeral)&#xD;
  &#xD;
            -  Muscle strength of three or less on the Medical Research Council Manual Muscle Testing&#xD;
               grading scale in any of the following (as appropriate for individuals with intact&#xD;
               limbs): shoulder abduction, elbow flexion, elbow extension, wrist extension, wrist&#xD;
               flexion, or finger extension&#xD;
  &#xD;
            -  Access to and willingness to use smart phone or tablet&#xD;
  &#xD;
            -  Able to tolerate participation in activity for at least 30 minutes of therapy&#xD;
               exercises per day for five days per week&#xD;
  &#xD;
            -  Able to provide written informed consent for study participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not able to read and understand English&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  History of prior central or peripheral neurologic injury or neuromuscular condition&#xD;
  &#xD;
            -  No muscle activation detectable by the mGain sEMG sensor&#xD;
  &#xD;
            -  Progressive neurologic deficit&#xD;
  &#xD;
            -  Impaired dexterity on the contralateral side such that participant is unable to use&#xD;
               the device&#xD;
  &#xD;
            -  Spasticity with modified Ashworth score of three or greater&#xD;
  &#xD;
            -  Severe joint contracture (&gt;50% of available range)&#xD;
  &#xD;
            -  Sensitive skin that would not tolerate wearing the mGain sEMG sensor&#xD;
  &#xD;
            -  Medical instability&#xD;
  &#xD;
            -  Confounding injury, musculoskeletal issues, or cognitive issues that limit effective&#xD;
               participation&#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>David Boone, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Orthocare Innovations, LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah Chang, PhD</last_name>
      <phone>+1 (425) 771-0797</phone>
      <email>schang@orthocareinnovations.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Orthocare Innovations, LLC</name>
        <address>
          <city>Edmonds</city>
          <state>Washington</state>
          <zip>98020</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sarah Chang, PhD</last_name>
        <phone>425-771-0797</phone>
        <email>schang@orthocareinnovations.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</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>Asthenia</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT06023316
  org study id: mGain-001
  nct id: NCT06023316
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile
        app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides
        biofeedback-based therapy in individuals with upper limb weakness due to neurologic injury or
        with upper limb amputation. Our overarching hypothesis is that the mGain wireless sEMG device
        and mobile therapeutic gaming environment will demonstrate improved adherence to therapy when
        compared to standard of care and will be feasible, acceptable, and usable in individuals with
        upper limb weakness or limb amputation.
  
        All participants will undertake four weeks of therapy. Conducting therapy five days a week
        for 30 minutes a day. In addition, participants will have an initial and final assessment
        visit at a study site, with each visit expected to last 1-2 hours.
  All participants will undertake four weeks of therapy. Conducting therapy five days a week
        for 30 minutes a day. In addition, participants will have an initial and final assessment
        visit at a study site, with each visit expected to last 1-2 hours.
  
        Initial Assessment: Eligible individuals will complete a baseline assessment including range
        of motion, manual muscle testing, and handheld dynamometry of the target limb(s). Target
        muscles for therapy will be identified (e.g., biceps, triceps, deltoids, forearm flexors,
        forearm extensors) and a trial of sEMG evaluation to detect muscle signal will be conducted.
        If detectable muscle signal is present, participants will complete the consent process and be
        enrolled in the study. Each participant will be taught the use of the mGain system using
        their own mobile phone or tablet and be given a therapeutic regimen to target their
        individual muscle weakness. Participants will then be asked to demonstrate use of the system.
        Participants can ask questions to ensure they understand system usage and the expectations
        when at home. Participants will complete baseline validated outcome measures such as the
        QuickDASH (Disabilities of the Arm, Shoulder and Hand questionnaire) and PROMIS Self-Efficacy
        Scale.
  
        Home Therapy: For the four weeks following the initial assessment, participants will be asked
        to conduct a minimum of 30 minutes of therapy per day, 5 days a week, at home using the mGain
        system targeting the muscles identified during the initial assessment. Individuals will be
        asked to complete short questionnaires and write in an eDiary about their experience after
        conducting their daily exercises. A member of the study team will contact the participants on
        a weekly basis to provide technical support, inquire about adherence, and encourage
        participation. Data for each participant will be uploaded to Orthocare Innovations' HIPAA
        compliant cloud-based server.
  
        Final Assessment: Participants will complete a final assessment of strength, range of motion,
        and manual muscle testing. Additionally, participants will complete outcome measures and
        surveys such as the QuickDASH, PROMIS Self-Efficacy, system usability scale, and a custom
        feasibility survey.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Pre Self-Efficacy
  time frame: At initial assessment before using intervention
  description: The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.
  measure: Post Self-Efficacy
  time frame: At final assessment after using intervention for four weeks
  description: The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.
  measure: System Usability Scale
  time frame: At final assessment after using intervention for four weeks
  description: The System Usability Scale measures the usability of a system and is a 10-item questionnaire completed by the participant; results in score 0-100 where scores above 68 would be considered above average.
  measure: pre-QuickDASH
  time frame: At initial assessment before using intervention
  description: QuickDASH (Disabilities of the Arm, Shoulder and Hand) is a validated patient-reported questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb; results in score 0-100 where 0 represents the least disability and 100 represents the greatest disability
  measure: post-QuickDASH
  time frame: At final assessment after using intervention for four weeks
  description: QuickDASH is a validated patient-reported questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb; results in score 0-100 where 0 represents the least disability and 100 represents the greatest disability
  arm group label: mGain system
  arm group type: Experimental
  description: mGain system: passive, noninvasive, Bluetooth-enabled, wire-free, surface electromyography measurement device that provides input to a mobile app for an interactive gaming platform
  intervention type: Device
  intervention name: mGain system
  description: passive, noninvasive surface electromyography measurement device and gaming mobile application
  arm group label: mGain system
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: David Boone, PhD
  role: Principal Investigator
  affiliation: Orthocare Innovations, LLC
  last name: Sarah Chang, PhD
  phone: +1 (425) 771-0797
  email: schang@orthocareinnovations.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Asthenia
  mesh term: Wounds and Injuries
  sharing ipd: No