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/NCT05975970</url>
    </required_header>
    <id_info>
      <org_study_id>W81XWH2010919</org_study_id>
      <nct_id>NCT05975970</nct_id>
    </id_info>
    <brief_title>A Patient-Driven Augmented Reality-Based Rehabilitation System to Improve Upper Limb Amputee Outcomes</brief_title>
    <official_title>A Patient-Driven Augmented Reality-Based Rehabilitation System to Improve Upper Limb Amputee Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Infinite Biomedical Technologies</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>United States Department of Defense</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Alberta</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Infinite Biomedical Technologies</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators propose to evaluate the efficacy of MyoTrain AR in a prospective clinical&#xD;
        study involving 10 individuals with trans-radial upper-limb loss over a period of 35 days.&#xD;
        These individuals will be randomized to Group A (Control Group using conventional motor&#xD;
        imagery exercises) and Group B (who will train with the MyoTrain AR system&#xD;
        pre-prosthetically).&#xD;
  &#xD;
        The investigators will test the following hypothesis: Pre-prosthetic training with the&#xD;
        MyoTrain AR system, as compared to the current standard of care with conventional motor&#xD;
        imagery exercises, results in improved subsequent control stability with the prosthesis.&#xD;
  &#xD;
        Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic&#xD;
        training period specific to their assigned Group. After this training period, participants&#xD;
        will repeat the functional assessment. Participants will then receive their prosthetic device&#xD;
        and occupational therapy consistent with the current clinical care standard, after which they&#xD;
        will again undergo a battery of validated, clinical assessments.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>GaMA Cup Transfer Task Mean Completion Time</measure>
      <time_frame>Day 35</time_frame>
      <description>The time to successfully complete the entire task trial (all 4 cup movements) from start to finish; averaged over all successful trials.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>GaMA Cup Transfer Task Mean Relative Grasp Duration</measure>
      <time_frame>Day 35</time_frame>
      <description>The percentage time spent in grasp phase relative to the entire movement (each movement involves reach-grasp-transport-release phases). This measure compensates for the expected inter-relation of absolute grasp duration with overall time, specifically identifying if grasp (object handling) is the main culprit in overall prolonged movement times.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment of Capacity for Myoelectric Controls (ACMC)</measure>
      <time_frame>Day 35</time_frame>
      <description>In contrast to other instruments, the ACMC does not require a specific set of tools or tasks. Instead, the proctor for the measure chooses an everyday activity, such as setting up a table for snacks or replanting a flower, that is relevant to the study population. As the participants perform the chosen task, a trained rater will assess their capacity for control of their myoelectric prosthesis as represented by 30 items reflecting 6 aspects of quality of myoelectric control. These 6 aspects are &quot;the need for external support,&quot; &quot;grip force and opening width,&quot; &quot;coordination of both hands, &quot;in different positions and in motion (timing),&quot; &quot;repetitive grip and release,&quot; and &quot;the need for visual feedback.&quot; Each item is scored on a 4-point scale and converted into linear measures of myoelectric control using Rasch analysis methods on the ACMC website. This outcome measure permits evaluation of bimanual tasks as well as different planes and work spaces of prosthesis use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GaMA Cup Transfer Task Completion Rate</measure>
      <time_frame>Day 35</time_frame>
      <description>Percentage of successful trials out of 10 attempts. Note that errors (unsuccessful trials) may include not grasping the cup, or dropping or crushing the cup while in transport. This metric is therefore a general (non-specific) indication of grasp stability throughout the functional task. Errors other than grasp stability can result in an unsuccessful trial (hitting the barrier during transport, knocking a cup over during release, performing task in the wrong sequence) therefore type of error will also be tracked.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GaMA Cup Transfer Task Wrist Activation</measure>
      <time_frame>Day 35</time_frame>
      <description>The ability to coordinate two DoF (hand + wrist movements) is measured by the degree of active wrist rotation from neutral (starting) position at the time of grasp initiation. This measure will identify if there is coordinated use of wrist rotation at the appropriate movement time (at the end of the reach phase) in order to facilitate grasp.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Amputation</condition>
    <condition>Upper Limb</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will undergo functional task training using the MyoTrain AR system, which includes the HoloLens 2 augmented reality head-mounted display, four HTC VIVE SteamVR kinematic trackers, eight surface EMG electrodes based on the Element hardware platform, and a desktop computer. Participants will be prompted to use a pattern recognition-based myoelectric controller to operate a virtual prosthesis and complete a simulation of the GaMA Cup Transfer Task.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be provided motor imagery exercises that involve brief attempts to move the missing limb in a similar manner to how they would control their pattern recognition system to strengthen their muscles. These exercises do not involve any real-time control feedback or functional assessment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MyoTrain AR</intervention_name>
      <description>MyoTrain AR is a virtual prosthesis functional training system. From a hardware perspective it consists of an augmented reality head-mounted display (HMD), four SteamVR kinematic trackers, eight surface EMG electrodes based on the Element electrode platform, and a desktop computer to facilitate wireless communication between the various hardware components. From a software perspective, MyoTrain AR was developed in the cross-platform Unity 4.0 game development engine.</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Motor Imagery</intervention_name>
      <description>Motor imagery describes the process by which a prosthesis user mentally simulates the execution of a desired limb movement and activates the musculature of the residual limb that would generate the desired movement.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Trans-radial unilateral limb loss with a healed residual limb&#xD;
  &#xD;
            -  Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis&#xD;
               as determined by the study prosthetist&#xD;
  &#xD;
            -  Fluent in English&#xD;
  &#xD;
            -  Age of 18 years or greater&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior experience with pattern recognition control&#xD;
  &#xD;
            -  Patients with a residual limb that is unhealed from the amputation surgery&#xD;
  &#xD;
            -  Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes&#xD;
  &#xD;
            -  Unhealed wounds&#xD;
  &#xD;
            -  Significant cognitive deficits as determined upon clinical evaluation&#xD;
  &#xD;
            -  Significant neurological deficits as determined upon clinical evaluation&#xD;
  &#xD;
            -  Significant physical deficits of the residual limb impacting full participation in the&#xD;
               study as determined upon clinical evaluation&#xD;
  &#xD;
            -  Uncontrolled pain or phantom pain impactive full participation in the study as&#xD;
               determined upon clinical evaluation&#xD;
  &#xD;
            -  Serious uncontrolled medical problems as judged by the project therapist&#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_contact>
      <last_name>Rahul R Kaliki, Ph.D</last_name>
      <phone>(443) 451-7175</phone>
      <email>rahul@i-biomed.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Alberta</name>
        <address>
          <city>Edmonton</city>
          <state>Alberta</state>
          <zip>T6G 2R3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jacqueline Hebert, MD, FRCPC</last_name>
        <phone>(780) 492-7846</phone>
        <email>jhebert@ualberta.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Infinite Biomedical Technologies</investigator_affiliation>
      <investigator_full_name>Rahul Kaliki</investigator_full_name>
      <investigator_title>Chief Executive Officer</investigator_title>
    </responsible_party>
    <keyword>amputation</keyword>
    <keyword>upper limb</keyword>
    <keyword>myoelectric</keyword>
    <keyword>training</keyword>
    <keyword>prosthesis</keyword>
    <keyword>augmented reality</keyword>
    <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/NCT05975970
  org study id: W81XWH2010919
  nct id: NCT05975970
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The investigators propose to evaluate the efficacy of MyoTrain AR in a prospective clinical
        study involving 10 individuals with trans-radial upper-limb loss over a period of 35 days.
        These individuals will be randomized to Group A (Control Group using conventional motor
        imagery exercises) and Group B (who will train with the MyoTrain AR system
        pre-prosthetically).
  
        The investigators will test the following hypothesis: Pre-prosthetic training with the
        MyoTrain AR system, as compared to the current standard of care with conventional motor
        imagery exercises, results in improved subsequent control stability with the prosthesis.
  
        Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic
        training period specific to their assigned Group. After this training period, participants
        will repeat the functional assessment. Participants will then receive their prosthetic device
        and occupational therapy consistent with the current clinical care standard, after which they
        will again undergo a battery of validated, clinical assessments.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: GaMA Cup Transfer Task Mean Completion Time
  time frame: Day 35
  description: The time to successfully complete the entire task trial (all 4 cup movements) from start to finish; averaged over all successful trials.
  measure: GaMA Cup Transfer Task Mean Relative Grasp Duration
  time frame: Day 35
  description: The percentage time spent in grasp phase relative to the entire movement (each movement involves reach-grasp-transport-release phases). This measure compensates for the expected inter-relation of absolute grasp duration with overall time, specifically identifying if grasp (object handling) is the main culprit in overall prolonged movement times.
  measure: Assessment of Capacity for Myoelectric Controls (ACMC)
  time frame: Day 35
  description: In contrast to other instruments, the ACMC does not require a specific set of tools or tasks. Instead, the proctor for the measure chooses an everyday activity, such as setting up a table for snacks or replanting a flower, that is relevant to the study population. As the participants perform the chosen task, a trained rater will assess their capacity for control of their myoelectric prosthesis as represented by 30 items reflecting 6 aspects of quality of myoelectric control. These 6 aspects are "the need for external support," "grip force and opening width," "coordination of both hands, "in different positions and in motion (timing)," "repetitive grip and release," and "the need for visual feedback." Each item is scored on a 4-point scale and converted into linear measures of myoelectric control using Rasch analysis methods on the ACMC website. This outcome measure permits evaluation of bimanual tasks as well as different planes and work spaces of prosthesis use.
  measure: GaMA Cup Transfer Task Completion Rate
  time frame: Day 35
  description: Percentage of successful trials out of 10 attempts. Note that errors (unsuccessful trials) may include not grasping the cup, or dropping or crushing the cup while in transport. This metric is therefore a general (non-specific) indication of grasp stability throughout the functional task. Errors other than grasp stability can result in an unsuccessful trial (hitting the barrier during transport, knocking a cup over during release, performing task in the wrong sequence) therefore type of error will also be tracked.
  measure: GaMA Cup Transfer Task Wrist Activation
  time frame: Day 35
  description: The ability to coordinate two DoF (hand + wrist movements) is measured by the degree of active wrist rotation from neutral (starting) position at the time of grasp initiation. This measure will identify if there is coordinated use of wrist rotation at the appropriate movement time (at the end of the reach phase) in order to facilitate grasp.
  arm group label: Experimental
  arm group type: Experimental
  description: Participants will undergo functional task training using the MyoTrain AR system, which includes the HoloLens 2 augmented reality head-mounted display, four HTC VIVE SteamVR kinematic trackers, eight surface EMG electrodes based on the Element hardware platform, and a desktop computer. Participants will be prompted to use a pattern recognition-based myoelectric controller to operate a virtual prosthesis and complete a simulation of the GaMA Cup Transfer Task.
  arm group label: Control
  arm group type: Active Comparator
  description: Participants will be provided motor imagery exercises that involve brief attempts to move the missing limb in a similar manner to how they would control their pattern recognition system to strengthen their muscles. These exercises do not involve any real-time control feedback or functional assessment.
  intervention type: Device
  intervention name: MyoTrain AR
  description: MyoTrain AR is a virtual prosthesis functional training system. From a hardware perspective it consists of an augmented reality head-mounted display (HMD), four SteamVR kinematic trackers, eight surface EMG electrodes based on the Element electrode platform, and a desktop computer to facilitate wireless communication between the various hardware components. From a software perspective, MyoTrain AR was developed in the cross-platform Unity 4.0 game development engine.
  arm group label: Experimental
  intervention type: Behavioral
  intervention name: Motor Imagery
  description: Motor imagery describes the process by which a prosthesis user mentally simulates the execution of a desired limb movement and activates the musculature of the residual limb that would generate the desired movement.
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rahul R Kaliki, Ph.D
  phone: (443) 451-7175
  email: rahul@i-biomed.com
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Infinite Biomedical Technologies
  investigator full name: Rahul Kaliki
  investigator title: Chief Executive Officer
  sharing ipd: No