<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/NCT04465019</url>
  </required_header>
  <id_info>
    <org_study_id>1492252</org_study_id>
    <nct_id>NCT04465019</nct_id>
  </id_info>
  <brief_title>Exoskeleton Rehabilitation on TBI</brief_title>
  <acronym>Ekso-TBI</acronym>
  <official_title>The Use of the Exoskeleton Robotic Device in the Rehabilitation of Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DHR Health Institute for Research and Development</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DHR Health Institute for Research and Development</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>
      Background: Traumatic brain injury (TBI) is one of the leading causes of disability in the&#xD;
      United States. The EKSO GT Bionics® (EKSO®) is a robotic exoskeleton approved by the Federal&#xD;
      Drug Administration (FDA) for rehabilitation following a cerebrovascular accident (CVA or&#xD;
      stroke) and recently received approval for use in patients with TBI. The aim of the study was&#xD;
      to examine if the use of exoskeleton rehabilitation in patients with TBI will produce&#xD;
      beneficial outcomes. Methods: This retrospective chart-review reports the use of the (EKSO®)&#xD;
      robotic device in the rehabilitation of patients with TBI compared to patients with CVA. The&#xD;
      investigators utilized data from a single, private rehabilitation hospital for patients that&#xD;
      received post-CVA or post-TBI robotic exoskeleton intervention. All patients that used the&#xD;
      exoskeleton were discharged from the hospital between 01/01/2017 to 04/30/2020. Ninety-four&#xD;
      percent (94%) of patients in the CVA groups and 100% of patients in the TBI group were of&#xD;
      Hispanic or Latino ethnicity. Gains in total Functional Independence Measure (FIM), walking&#xD;
      and cognition, and length of stay in the rehabilitation facility were measured. Results:&#xD;
      Patients in the TBI group (n=11) were significantly younger than the patients in the CVA&#xD;
      group (n=66; p&lt; 0.05). Both groups spent a similar amount of time active, number of steps&#xD;
      taken, and the number of sessions in the exoskeleton. Both groups also started with similar&#xD;
      admission FIM scores. The FIM gain in the TBI group was similar to that of the CVA group&#xD;
      (37.5 and 32.0 respectively). The length of stay between groups was not different either.&#xD;
      Conclusions: The use of exoskeleton rehabilitation in patients with TBI appear to produce&#xD;
      similar outcomes as for patients with CVA, prompting further attention of this intervention&#xD;
      for this type of injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design and Setting&#xD;
&#xD;
      This is an observational, retrospective, chart review cohort study of patients from a private&#xD;
      single rehabilitation hospital. Study approval was granted by the local Institutional Review&#xD;
      Board and conformed to the Declaration of Helsinki and the US Federal Policy for the&#xD;
      Protection of Human Subjects. Due to the retrospective nature of the study, a full waiver of&#xD;
      authorization under the Health Insurance Portability and Accountability Act (1996) was&#xD;
      submitted by the study team and approved by the Institutional Review Board.&#xD;
&#xD;
      Participants&#xD;
&#xD;
      Inclusion and Exclusion criteria: Subjects in the TBI group included patients who suffered a&#xD;
      TBI and who used the EKSO® bionic exoskeleton during their rehabilitation treatment from&#xD;
      01/01/2017 to 04/30/2020. Subjects in the CVA group included all patients in the hospital&#xD;
      that used the EKSO® during their rehabilitation process during the same period of the&#xD;
      patients in the TBI group. Patients were excluded if their injury type was outside the scope&#xD;
      of the current study. The registered nurse at the rehabilitation facility identified the&#xD;
      patients based on the inclusion criteria, and this was verified by the doctor in physical&#xD;
      therapy who oversees the rehabilitation hospital patient population. Approval and&#xD;
      implementation of the EKSO® bionic device at the hospital commenced in 2014 for patients that&#xD;
      suffered a CVA and spinal cord injury. Main indications for the use of the EKSO® during&#xD;
      rehabilitation included a height range between 1.56 to 1.9 meters and a patient's weight&#xD;
      equal to or less than 100kg. Stable blood pressure was required, with the ability to follow&#xD;
      one to two steps commands, and the patient should also have demonstrated a normal range of&#xD;
      motion in hips, knees, and ankles.&#xD;
&#xD;
      Variables&#xD;
&#xD;
      Demographic factors considered in this study were age at the time of admission into the&#xD;
      rehabilitation facility (measured in years), and patient's sex (males or females). Ethnicity&#xD;
      was self-reported and collected in the study, but it was not considered as a covariate since&#xD;
      the vast majority of our cohort was of Hispanic origin. The overrepresentation of&#xD;
      Hispanics/Latinos in the current cohort responds to the demographic distribution of the area&#xD;
      the hospital serves. The investigators collected information related to the impairment type&#xD;
      produced by the CVA, and for the TBI; investigators collected the abbreviated injury scale&#xD;
      (ASI) to determine the injury severity score (ISS).&#xD;
&#xD;
      The change in FIM score from admission to discharge was used as the primary outcome for this&#xD;
      study. The FIM score evaluates the ability of the patient in day-to-day functions within&#xD;
      three (3) major categories: self-care, mobility, and communication. To explore whether the&#xD;
      use of EKSO® facilitates the improvement in mobility and communication, investigators also&#xD;
      explored the motor FIM and social interaction FIM, problem-solving FIM, and memory FIM. In&#xD;
      parallel to FIM, investigators evaluated how the length of stay in the facility affected the&#xD;
      outcomes.&#xD;
&#xD;
      Data sources/measurements&#xD;
&#xD;
      Variables collected in this study were retrospectively obtained from the patient's electronic&#xD;
      medical chart. All information presented in this study was part of the patient's standard of&#xD;
      care. No additional intervention or data collection instrument was implemented. The standard&#xD;
      of care of the patient is as follows: all potentially eligible candidates were identified and&#xD;
      cleared by the physician with subsequent patient education regarding the use of the EKSO®.&#xD;
      For the use of the exoskeleton during the rehabilitation process, signed informed consent was&#xD;
      obtained from either the patient or designated family member, depending on the status of the&#xD;
      patient. Data obtained during the active use of the exoskeleton was visualized in the screen&#xD;
      of the EKSO® (time active, steps taken, etc.) and subsequently recorded in each patient's&#xD;
      paper chart. This paper was then scanned and uploaded into the patient's electronic chart&#xD;
      under his/her progress notes. The therapy technicians helped in the data recording process.&#xD;
      All available data related to EKSO use for CVA and TBI at our facility were included in the&#xD;
      current study. The primary goal of the data analysis was to gather preliminary comparative&#xD;
      outcomes that could guide us into designing larger-controlled studies.&#xD;
&#xD;
      Reduction of Bias&#xD;
&#xD;
      To minimize selection bias in the current study, investigators used all patients that were&#xD;
      clinically determined by the attending physician to meet the criteria for exoskeleton&#xD;
      rehabilitation. Patients were included in the chart review regardless of the number of&#xD;
      sessions of exoskeleton use. All therapist and nurses at our facility have been certified to&#xD;
      use the FIM assessment tool and the data is entered using the Uniform Data System for Medical&#xD;
      Rehabilitation (https://www.udsmr.org/) software integrated within the hospital medical&#xD;
      record platform. The main data extractor in the study (A.M.) is the site expert for data&#xD;
      management within the Uniform Data System. Quality of the data was verified by the lead&#xD;
      doctor in Physical Therapy (M.E.A.). None of the patients that used exoskeleton in&#xD;
      rehabilitation had missing data during the time period used for the current study and all&#xD;
      patients in the cohort completed the recommended therapeutic program and were successfully&#xD;
      discharged from the hospital.&#xD;
&#xD;
      Exoskeleton use protocol&#xD;
&#xD;
      The EKSO GT® was operated by a Licensed Physical Therapist who was certified to control the&#xD;
      device. The device is only approved to be used in a clinical setting. For the purposes of&#xD;
      this study, four different modes were utilized to engage and challenge the patients:&#xD;
      Pre-Gait, First Step, Pro Step Plus, and 2 Free. Pre-Gait Mode focused on the following&#xD;
      metrics to facilitate movement and active participation: bilateral weight shifting in&#xD;
      standing with biofeedback, mini squats, and stationary unilateral lower extremity&#xD;
      advancement. The First Step mode allowed the therapist to be in full control of all movement.&#xD;
      The therapist triggered the initiation and execution of each step reciprocally with the push&#xD;
      of a button. In the Pro Step Plus mode, there was an appropriate weight shift either done&#xD;
      independently by the patient or facilitated by the therapeutic handling of the physical&#xD;
      therapist. The patient was given the opportunity to initiate each step; the EKSO® device&#xD;
      completed any incomplete steps. The most advanced mode is called 2 Free. This mode was used&#xD;
      to challenge the patient across the continuum as they progress. The patient was responsible&#xD;
      for initiating and executing each step. The therapist programmed resistance unilaterally or&#xD;
      bilaterally to the lower extremities to increase the demand for the activity.&#xD;
&#xD;
      Statistical methods&#xD;
&#xD;
      Descriptive statistics for the entire study population were generated. Normally distributed&#xD;
      continuous variables were described with means and standard deviations, medians and ranges&#xD;
      were used for non-normally distributed variables, and frequencies and column percentages&#xD;
      summarized categorical variables. Differences in demographic and clinical characteristics&#xD;
      between the two treatment groups were evaluated using Student t-test for independent samples&#xD;
      for normally distributed continuous variables, Mann-Whitney U test for non-normally&#xD;
      distributed continuous variables, and Fisher exact test for categorical variables. To test&#xD;
      for the difference between the CVA and TBI groups in respect to socio-demographic and&#xD;
      treatment measurements, paired t-test or Wilcoxon signed-rank test for continuous variables&#xD;
      and Chi-square test/Fisher exact test for categorical variables were used. Shapiro-Wilk test&#xD;
      for normality was conducted to determine the normality of the continuous variables'&#xD;
      distributions. Linear regression analyses were carried out to evaluate the associations of&#xD;
      each of the outcome variables with age, sex, and length of hospital stay, and with the injury&#xD;
      groups (CVA and TBI) variable. All statistical tests were two-sided and were performed at a&#xD;
      significance level of 0.05. All statistical analyses were conducted using SAS 9.4 (SAS&#xD;
      Institute, Inc, Cary, North Carolina, USA.).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 3, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Functional Independence Measure</measure>
    <time_frame>Ten weeks</time_frame>
    <description>Increase in FIM from Admission to Discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of steps taken in the exoskeleton</measure>
    <time_frame>Inpatient stay at the rehabilitation hospital</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time active in the exoskeleton</measure>
    <time_frame>Inpatient stay at the rehabilitation hospital</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">77</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Cerebral Stroke</condition>
  <arm_group>
    <arm_group_label>TBI Group</arm_group_label>
    <description>Subjects in the TBI group included patients who suffered a TBI and who used the EKSO® bionic exoskeleton during their rehabilitation treatment from 01/01/2017 to 04/30/2020.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CVA Group</arm_group_label>
    <description>Subjects in the CVA group included all patients in the hospital that used the EKSO® during their rehabilitation process during their rehabilitation treatment from 01/01/2017 to 04/30/2020.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exoskeleton Rehabilitation</intervention_name>
    <description>The EKSO GT® was operated by a Licensed Physical Therapist who was certified to control the device. We followed a strictly established protocol for operating the device during the rehabilitation process as established by the company.</description>
    <arm_group_label>CVA Group</arm_group_label>
    <arm_group_label>TBI Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 66 (10.7%) and 11 (7.9%) patients met the criteria and agreed to use the&#xD;
        exoskeleton for CVA and TBI respectively. More than 90% of the study population is of&#xD;
        Hispanic ethnicity.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Main indications for the use of the EKSO® during rehabilitation included a height&#xD;
             range between 1.56 to 1.9 meters and a patient's weight equal to or less than 100kg.&#xD;
&#xD;
          -  Stable blood pressure was required, with the ability to follow one to two steps&#xD;
             commands, and the patient should also have demonstrated a normal range of motion in&#xD;
             hips, knees, and ankles.&#xD;
&#xD;
          -  Patient must have suffered a traumatic brain injury or stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded if their injury type was outside the scope of the current&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DHR Health Rehabilitation Hospital</name>
      <address>
        <city>Edinburg</city>
        <state>Texas</state>
        <zip>78539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>DHR Health Institute for Research and Development</investigator_affiliation>
    <investigator_full_name>Lisa Trevino</investigator_full_name>
    <investigator_title>Vice President</investigator_title>
  </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>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Interested parties must contact the corresponding author to provide individual data sets.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Up to two years after data publication</ipd_time_frame>
    <ipd_access_criteria>Contact Principal Investigator</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04465019
org study id: 1492252
nct id: NCT04465019
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Background: Traumatic brain injury (TBI) is one of the leading causes of disability in the
      United States. The EKSO GT Bionics® (EKSO®) is a robotic exoskeleton approved by the Federal
      Drug Administration (FDA) for rehabilitation following a cerebrovascular accident (CVA or
      stroke) and recently received approval for use in patients with TBI. The aim of the study was
      to examine if the use of exoskeleton rehabilitation in patients with TBI will produce
      beneficial outcomes. Methods: This retrospective chart-review reports the use of the (EKSO®)
      robotic device in the rehabilitation of patients with TBI compared to patients with CVA. The
      investigators utilized data from a single, private rehabilitation hospital for patients that
      received post-CVA or post-TBI robotic exoskeleton intervention. All patients that used the
      exoskeleton were discharged from the hospital between 01/01/2017 to 04/30/2020. Ninety-four
      percent (94%) of patients in the CVA groups and 100% of patients in the TBI group were of
      Hispanic or Latino ethnicity. Gains in total Functional Independence Measure (FIM), walking
      and cognition, and length of stay in the rehabilitation facility were measured. Results:
      Patients in the TBI group (n=11) were significantly younger than the patients in the CVA
      group (n=66; p< 0.05). Both groups spent a similar amount of time active, number of steps
      taken, and the number of sessions in the exoskeleton. Both groups also started with similar
      admission FIM scores. The FIM gain in the TBI group was similar to that of the CVA group
      (37.5 and 32.0 respectively). The length of stay between groups was not different either.
      Conclusions: The use of exoskeleton rehabilitation in patients with TBI appear to produce
      similar outcomes as for patients with CVA, prompting further attention of this intervention
      for this type of injury.
Study Design and Setting

      This is an observational, retrospective, chart review cohort study of patients from a private
      single rehabilitation hospital. Study approval was granted by the local Institutional Review
      Board and conformed to the Declaration of Helsinki and the US Federal Policy for the
      Protection of Human Subjects. Due to the retrospective nature of the study, a full waiver of
      authorization under the Health Insurance Portability and Accountability Act (1996) was
      submitted by the study team and approved by the Institutional Review Board.

      Participants

      Inclusion and Exclusion criteria: Subjects in the TBI group included patients who suffered a
      TBI and who used the EKSO® bionic exoskeleton during their rehabilitation treatment from
      01/01/2017 to 04/30/2020. Subjects in the CVA group included all patients in the hospital
      that used the EKSO® during their rehabilitation process during the same period of the
      patients in the TBI group. Patients were excluded if their injury type was outside the scope
      of the current study. The registered nurse at the rehabilitation facility identified the
      patients based on the inclusion criteria, and this was verified by the doctor in physical
      therapy who oversees the rehabilitation hospital patient population. Approval and
      implementation of the EKSO® bionic device at the hospital commenced in 2014 for patients that
      suffered a CVA and spinal cord injury. Main indications for the use of the EKSO® during
      rehabilitation included a height range between 1.56 to 1.9 meters and a patient's weight
      equal to or less than 100kg. Stable blood pressure was required, with the ability to follow
      one to two steps commands, and the patient should also have demonstrated a normal range of
      motion in hips, knees, and ankles.

      Variables

      Demographic factors considered in this study were age at the time of admission into the
      rehabilitation facility (measured in years), and patient's sex (males or females). Ethnicity
      was self-reported and collected in the study, but it was not considered as a covariate since
      the vast majority of our cohort was of Hispanic origin. The overrepresentation of
      Hispanics/Latinos in the current cohort responds to the demographic distribution of the area
      the hospital serves. The investigators collected information related to the impairment type
      produced by the CVA, and for the TBI; investigators collected the abbreviated injury scale
      (ASI) to determine the injury severity score (ISS).

      The change in FIM score from admission to discharge was used as the primary outcome for this
      study. The FIM score evaluates the ability of the patient in day-to-day functions within
      three (3) major categories: self-care, mobility, and communication. To explore whether the
      use of EKSO® facilitates the improvement in mobility and communication, investigators also
      explored the motor FIM and social interaction FIM, problem-solving FIM, and memory FIM. In
      parallel to FIM, investigators evaluated how the length of stay in the facility affected the
      outcomes.

      Data sources/measurements

      Variables collected in this study were retrospectively obtained from the patient's electronic
      medical chart. All information presented in this study was part of the patient's standard of
      care. No additional intervention or data collection instrument was implemented. The standard
      of care of the patient is as follows: all potentially eligible candidates were identified and
      cleared by the physician with subsequent patient education regarding the use of the EKSO®.
      For the use of the exoskeleton during the rehabilitation process, signed informed consent was
      obtained from either the patient or designated family member, depending on the status of the
      patient. Data obtained during the active use of the exoskeleton was visualized in the screen
      of the EKSO® (time active, steps taken, etc.) and subsequently recorded in each patient's
      paper chart. This paper was then scanned and uploaded into the patient's electronic chart
      under his/her progress notes. The therapy technicians helped in the data recording process.
      All available data related to EKSO use for CVA and TBI at our facility were included in the
      current study. The primary goal of the data analysis was to gather preliminary comparative
      outcomes that could guide us into designing larger-controlled studies.

      Reduction of Bias

      To minimize selection bias in the current study, investigators used all patients that were
      clinically determined by the attending physician to meet the criteria for exoskeleton
      rehabilitation. Patients were included in the chart review regardless of the number of
      sessions of exoskeleton use. All therapist and nurses at our facility have been certified to
      use the FIM assessment tool and the data is entered using the Uniform Data System for Medical
      Rehabilitation (https://www.udsmr.org/) software integrated within the hospital medical
      record platform. The main data extractor in the study (A.M.) is the site expert for data
      management within the Uniform Data System. Quality of the data was verified by the lead
      doctor in Physical Therapy (M.E.A.). None of the patients that used exoskeleton in
      rehabilitation had missing data during the time period used for the current study and all
      patients in the cohort completed the recommended therapeutic program and were successfully
      discharged from the hospital.

      Exoskeleton use protocol

      The EKSO GT® was operated by a Licensed Physical Therapist who was certified to control the
      device. The device is only approved to be used in a clinical setting. For the purposes of
      this study, four different modes were utilized to engage and challenge the patients:
      Pre-Gait, First Step, Pro Step Plus, and 2 Free. Pre-Gait Mode focused on the following
      metrics to facilitate movement and active participation: bilateral weight shifting in
      standing with biofeedback, mini squats, and stationary unilateral lower extremity
      advancement. The First Step mode allowed the therapist to be in full control of all movement.
      The therapist triggered the initiation and execution of each step reciprocally with the push
      of a button. In the Pro Step Plus mode, there was an appropriate weight shift either done
      independently by the patient or facilitated by the therapeutic handling of the physical
      therapist. The patient was given the opportunity to initiate each step; the EKSO® device
      completed any incomplete steps. The most advanced mode is called 2 Free. This mode was used
      to challenge the patient across the continuum as they progress. The patient was responsible
      for initiating and executing each step. The therapist programmed resistance unilaterally or
      bilaterally to the lower extremities to increase the demand for the activity.

      Statistical methods

      Descriptive statistics for the entire study population were generated. Normally distributed
      continuous variables were described with means and standard deviations, medians and ranges
      were used for non-normally distributed variables, and frequencies and column percentages
      summarized categorical variables. Differences in demographic and clinical characteristics
      between the two treatment groups were evaluated using Student t-test for independent samples
      for normally distributed continuous variables, Mann-Whitney U test for non-normally
      distributed continuous variables, and Fisher exact test for categorical variables. To test
      for the difference between the CVA and TBI groups in respect to socio-demographic and
      treatment measurements, paired t-test or Wilcoxon signed-rank test for continuous variables
      and Chi-square test/Fisher exact test for categorical variables were used. Shapiro-Wilk test
      for normality was conducted to determine the normality of the continuous variables'
      distributions. Linear regression analyses were carried out to evaluate the associations of
      each of the outcome variables with age, sex, and length of hospital stay, and with the injury
      groups (CVA and TBI) variable. All statistical tests were two-sided and were performed at a
      significance level of 0.05. All statistical analyses were conducted using SAS 9.4 (SAS
      Institute, Inc, Cary, North Carolina, USA.).
observational model: Cohort
time perspective: Retrospective
measure: Change in Functional Independence Measure
time frame: Ten weeks
description: Increase in FIM from Admission to Discharge
measure: Number of steps taken in the exoskeleton
time frame: Inpatient stay at the rehabilitation hospital
measure: Time active in the exoskeleton
time frame: Inpatient stay at the rehabilitation hospital
arm group label: TBI Group
description: Subjects in the TBI group included patients who suffered a TBI and who used the EKSO® bionic exoskeleton during their rehabilitation treatment from 01/01/2017 to 04/30/2020.
arm group label: CVA Group
description: Subjects in the CVA group included all patients in the hospital that used the EKSO® during their rehabilitation process during their rehabilitation treatment from 01/01/2017 to 04/30/2020.
intervention type: Device
intervention name: Exoskeleton Rehabilitation
description: The EKSO GT® was operated by a Licensed Physical Therapist who was certified to control the device. We followed a strictly established protocol for operating the device during the rehabilitation process as established by the company.
arm group label: CVA Group
arm group label: TBI Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: DHR Health Institute for Research and Development
investigator full name: Lisa Trevino
investigator title: Vice President
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Stroke
sharing ipd: Yes
ipd description: Interested parties must contact the corresponding author to provide individual data sets.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Up to two years after data publication
ipd access criteria: Contact Principal Investigator