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/NCT05977270</url>
    </required_header>
    <id_info>
      <org_study_id>2021-A00072-39</org_study_id>
      <nct_id>NCT05977270</nct_id>
    </id_info>
    <brief_title>The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury</brief_title>
    <acronym>LBO_LCA</acronym>
    <official_title>Evaluation of the Effects of Lifebloom One on Physical Activity After Acquired Brain Injury: A Single-Case Experimental Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lifebloom</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pitié-Salpêtrière Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Lifebloom</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>
        The goal of this clinical trial is to evaluate the effects of Lifebloom One in people who&#xD;
        have suffered a stroke or a traumatic brain injury.&#xD;
  &#xD;
        The main questions to be answered are:&#xD;
  &#xD;
          -  Does Lifebloom One allow users to spend more time standing each day?&#xD;
  &#xD;
          -  Does Lifebloom One allow users to improve their balance and gait?&#xD;
  &#xD;
        Participants will use Lifebloom One during 8 weeks.&#xD;
  &#xD;
        For each participant, gait and balance are compared either with and without Oxilio or before&#xD;
        and after Lifebloom One intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 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>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single Case Experimental Design with multiple baselines across individuals</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of daily time spent standing change</measure>
      <time_frame>Change from baseline to intervention phase</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>10 meter walk test change</measure>
      <time_frame>Change from baseline to intervention phase</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Ambulation Categories (FAC) change</measure>
      <time_frame>Change from baseline to intervention phase</time_frame>
      <description>6-point scale. A score of 0 indicates that the patient is a non-functional ambulator, a score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3) and a score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Berg Balance Scale change</measure>
      <time_frame>Change from baseline to intervention phase</time_frame>
      <description>In this 14-item scale, patients must maintain positions and complete moving tasks of varying difficulty. In most items, patients must maintain a given position for a specified time. Patients receive a score from 0-4 on their ability to meet these balance dimensions. A global score can be calculated out of 56. A score of 0 represents an inability to complete the item, and a score of 56 represents the ability to independently complete the item.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue Severity Scale change</measure>
      <time_frame>Change from baseline to intervention phase</time_frame>
      <description>A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6 minutes walk test</measure>
      <time_frame>From the beginning and until the end of the intervention phase (during 8 weeks, one time per week)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barthel Index (BI)</measure>
      <time_frame>Before baseline, twice during the intervention phase, at immediate post-intervention</time_frame>
      <description>The score of the BI is a summed aggregate and there is preferential weighting on mobility and continence. The scores are allotted in the following way: 0 or 5 points per item for bathing and grooming; 0, 5, or 10 points per item for feeding, dressing, bowel control, bladder control, toilet use, and stairs; 0, 5, 10, or 15 points per item for transfers and mobility. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke Specific Quality of Life Scale</measure>
      <time_frame>Before baseline, at immediate post-intervention</time_frame>
      <description>It is a self-report scale containing 49 items. Items are rated on a 5-point Likert scale. Higher scores indicate better functioning.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire - 9</measure>
      <time_frame>Before baseline, at immediate post-intervention</time_frame>
      <description>The PHQ-9 contains the 9 items. Each item is evaluated on a severity scale ranging from 0 to 3 where the respondent is asked to rate how often each symptom occurred over the last 2 weeks (0-not at all; 1-several days; 2-more than half of the days or 3-nearly every day), yielding a total score ranging from 0-27. Score interpretation:1-4 minimal depression; 5-9 mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-27 severe depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)</measure>
      <time_frame>at immediate post-intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychosocial Impact of Assistive Device Scale (F-PIADS)</measure>
      <time_frame>at immediate post-intervention</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">5</enrollment>
    <condition>Stroke</condition>
    <condition>Brain Injuries, Traumatic</condition>
    <arm_group>
      <arm_group_label>Lifebloom One intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Lifebloom One</intervention_name>
      <description>LBO is made of Oxilio, an alternative to wheelchair placement for everyday use.</description>
      <arm_group_label>Lifebloom One intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Stroke or traumatic brain injury more than 2 months old&#xD;
  &#xD;
            -  Unable to walk without assistance&#xD;
  &#xD;
            -  Expected length of stay equal to or greater than 4 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Anthropometric incompatibility with Oxilio&#xD;
  &#xD;
            -  Unable to walk prior to brain injury&#xD;
  &#xD;
            -  No functional upper limb&#xD;
  &#xD;
            -  Complete sensory deficit in the lower limb(s)&#xD;
  &#xD;
            -  Degenerative impairment (tumor, neurodegenerative disease, etc.)&#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>Eleonore Bayen, PUPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pitié-Salpêtrière Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Claire Kemlin, PhD</last_name>
      <phone>+33633307568</phone>
      <email>claire.kemlin@lifebloom.eu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marc Bardgett</last_name>
      <phone>+33609507060</phone>
      <email>marc.bardgett@lifebloom.eu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Physical Medicine and Rehabilitation Department - Pitié-Salpêtrière Hospital</name>
        <address>
          <city>Paris</city>
          <zip>75013</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Eléonore Bayen, PUPH</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 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>Brain Injuries</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</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/NCT05977270
  org study id: 2021-A00072-39
  nct id: NCT05977270
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the effects of Lifebloom One in people who
        have suffered a stroke or a traumatic brain injury.
  
        The main questions to be answered are:
  
          -  Does Lifebloom One allow users to spend more time standing each day?
  
          -  Does Lifebloom One allow users to improve their balance and gait?
  
        Participants will use Lifebloom One during 8 weeks.
  
        For each participant, gait and balance are compared either with and without Oxilio or before
        and after Lifebloom One intervention.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single Case Experimental Design with multiple baselines across individuals
  primary purpose: Other
  masking: None (Open Label)
  measure: Assessment of daily time spent standing change
  time frame: Change from baseline to intervention phase
  measure: 10 meter walk test change
  time frame: Change from baseline to intervention phase
  measure: Functional Ambulation Categories (FAC) change
  time frame: Change from baseline to intervention phase
  description: 6-point scale. A score of 0 indicates that the patient is a non-functional ambulator, a score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3) and a score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score).
  measure: Berg Balance Scale change
  time frame: Change from baseline to intervention phase
  description: In this 14-item scale, patients must maintain positions and complete moving tasks of varying difficulty. In most items, patients must maintain a given position for a specified time. Patients receive a score from 0-4 on their ability to meet these balance dimensions. A global score can be calculated out of 56. A score of 0 represents an inability to complete the item, and a score of 56 represents the ability to independently complete the item.
  measure: Fatigue Severity Scale change
  time frame: Change from baseline to intervention phase
  description: A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
  measure: 6 minutes walk test
  time frame: From the beginning and until the end of the intervention phase (during 8 weeks, one time per week)
  measure: Barthel Index (BI)
  time frame: Before baseline, twice during the intervention phase, at immediate post-intervention
  description: The score of the BI is a summed aggregate and there is preferential weighting on mobility and continence. The scores are allotted in the following way: 0 or 5 points per item for bathing and grooming; 0, 5, or 10 points per item for feeding, dressing, bowel control, bladder control, toilet use, and stairs; 0, 5, 10, or 15 points per item for transfers and mobility. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence.
  measure: Stroke Specific Quality of Life Scale
  time frame: Before baseline, at immediate post-intervention
  description: It is a self-report scale containing 49 items. Items are rated on a 5-point Likert scale. Higher scores indicate better functioning.
  measure: Patient Health Questionnaire - 9
  time frame: Before baseline, at immediate post-intervention
  description: The PHQ-9 contains the 9 items. Each item is evaluated on a severity scale ranging from 0 to 3 where the respondent is asked to rate how often each symptom occurred over the last 2 weeks (0-not at all; 1-several days; 2-more than half of the days or 3-nearly every day), yielding a total score ranging from 0-27. Score interpretation:1-4 minimal depression; 5-9 mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-27 severe depression.
  measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
  time frame: at immediate post-intervention
  measure: Psychosocial Impact of Assistive Device Scale (F-PIADS)
  time frame: at immediate post-intervention
  arm group label: Lifebloom One intervention
  arm group type: Experimental
  intervention type: Device
  intervention name: Lifebloom One
  description: LBO is made of Oxilio, an alternative to wheelchair placement for everyday use.
  arm group label: Lifebloom One intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eleonore Bayen, PUPH
  role: Principal Investigator
  affiliation: Pitié-Salpêtrière Hospital
  last name: Claire Kemlin, PhD
  phone: +33633307568
  email: claire.kemlin@lifebloom.eu
  last name: Marc Bardgett
  phone: +33609507060
  email: marc.bardgett@lifebloom.eu
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  mesh term: Wounds and Injuries
  sharing ipd: No