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/NCT06028529</url>
    </required_header>
    <id_info>
      <org_study_id>N4387-P</org_study_id>
      <nct_id>NCT06028529</nct_id>
    </id_info>
    <brief_title>Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease</brief_title>
    <official_title>Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of 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>
        Physical therapy approaches for balance and walking deficits in Parkinson's disease (PD) have&#xD;
        limited effectiveness, with mostly short-lasting benefits. An exoskeleton is a device that&#xD;
        straps to the legs and provides a passive force to assist people to better ambulate. The goal&#xD;
        of this study is to establish the feasibility and safety of a lightweight exoskeleton on&#xD;
        mobility and fall reduction in people with PD. As most PD patients eventually require&#xD;
        assistive mobility devices, the exoskeleton represents a new option for increased, mobility,&#xD;
        quality of life, and independence. Qualified subjects will come to the clinic twice weekly&#xD;
        for six weeks (12 total visits) and wear the exoskeleton device while walking under the&#xD;
        supervision of a trained physical therapist. Study staff will also interview participants and&#xD;
        assess their PD symptoms, quality of life, and overall mobility. This study hopes to&#xD;
        establish exoskeletons as modern, standard of care devices, which allow people with PD to&#xD;
        maintain more independent and productive lives.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Currently, progressive resistance exercise training, high intensity treadmill training,&#xD;
        balanced-based perturbation, and standard physical exercises are utilized to treat mobility&#xD;
        deficits associated with PD; however, the effectiveness of these therapies is limited. This&#xD;
        study proposes to investigate the utility of a portable exoskeleton for people with PD. The&#xD;
        goal is to establish the safety of a lightweight portable exoskeleton, the Keeogo, for gait&#xD;
        training and to preliminarily assess its potential efficacy for gait mobility and fall&#xD;
        reduction. As the vast majority of PD patients eventually require assistive mobility devices,&#xD;
        portable exoskeletons represents an avenue for increased, mobility, quality of life, and&#xD;
        independence. Robotic-assist gait training (RAGT) has been extensively applied as a&#xD;
        remarkable therapeutic modality, such that it is enabling highly motivated people with&#xD;
        devastating neurologic injuries to regain independent ambulation. Despite the potential for&#xD;
        this technology to transform the lives of people with PD, these devices are not being&#xD;
        adequately investigated in people with movement disorders.&#xD;
  &#xD;
        To establish preliminary safety and efficiency of the Keeogo exoskeleton for PD patients at&#xD;
        various disease stages, the investigators will examine representative subjects in Hohen &amp;&#xD;
        Yahr stages II, III, IV, and V. Inclusion criteria are: 1) PD confirmed by a PADRECC movement&#xD;
        disorder specialist using UK Brain Bank Criteria, 2) Modified H&amp;Y stage II-V. Exclusion&#xD;
        criteria are: 1) neurological, musculoskeletal, or other disorders unrelated to PD&#xD;
        contributing to impairment of stance, gait, balance or coordination, 2) severe CHF, COPD, or&#xD;
        those requiring nasal canula O2, 3) history of implantable cardiac device or ablative&#xD;
        surgery, 4) moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment&#xD;
        &lt; 17/30), 5) symptomatic orthostatic hypotension with exertion, 6) feeding tube or associated&#xD;
        port placement (PEG/J-PEG), 7) body height less than 5'1&quot; or greater than 6'3&quot; 8) body weight&#xD;
        greater than 250 pounds, and 9) amputation of any portion of the lower limbs. Subjects will&#xD;
        participate in a total of 30 minutes RAGT ambulation with the Keeogo twice per week for 6&#xD;
        weeks (12 sessions). Subjects may opt to utilize a platform rolling walker, rolling walker,&#xD;
        bilateral Lofstrand crutches or a unilateral device, such as a cane or Lofstrand crutch, and&#xD;
        will be maintained throughout the intervention.&#xD;
  &#xD;
        To establish safety, the number and severity of AEs, such as falls, discomfort, skin or&#xD;
        musculoskeletal injury, and orthostatic hypotensive episodes will be documented. Intervention&#xD;
        efficacy will be measured pre- and post-donning of the Keeogo exoskeleton at bi-weekly&#xD;
        intervention visits, and at a 6-week post-study visit. Walking capacity, including benefits&#xD;
        on FoG, will be assessed with the Six Minute Walk Test (6MWT), balance and postural stability&#xD;
        with the Berg Balance Scale (BBS), and disease severity with the Examination, Part III, of&#xD;
        the Unified Parkinson's Disease Rating Scale (UPDRS). Additional assessments will include&#xD;
        Berg Balance Scale (BBS), ascending and descending stair climb, PDQ39, The University of&#xD;
        Alabama at Birmingham (UAB) Study of Aging Life-Space Assessment (LSA), and PD-Carer. As a&#xD;
        primary end point for establishing efficacy, the 6MWT will be compared between end of&#xD;
        training and baseline (with and without the exoskeleton), as well as at 6 and 12 weeks&#xD;
        post-study as a durability assessment towards establishing a need for future assessment of&#xD;
        in-home usage. These pilot investigations are expected to lay the groundwork for a large&#xD;
        multi-center clinical study to establish ground exoskeletons as modern, standard of care&#xD;
        devices to aid Veterans and other people with PD and other disabling movement disorders to&#xD;
        maintain a more normal and productive life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</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>Safety, tolerability, feasibility, methodological assessment, and sample characteristics with consideration of multiple staging and high patient variability towards the design of a future clinical efficacy study.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change</measure>
      <time_frame>Through last training visit (weeks 1-6, 12 sessions)</time_frame>
      <description>Patients will be continuously supervised by a trained physical therapist and the expectation is that there will be no falls while wearing the device. All primary safety and tolerability measures will be separately assessed with consideration of H&amp;Y staging (2-4; max. 5) and cognition (based on MOCA scores 0 = nl, max. 30).&#xD;
  -Minimal attrition rate based on subjects being unable to complete the protocol. This could for example establish that the Keeogo device is not tolerated by more advanced (H&amp;Y Stage 5) patients, but is acceptable for others.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Attrition (Tolerability) Change</measure>
      <time_frame>Through last training visit (weeks 1-6, 12 sessions)</time_frame>
      <description>The expectation is that there will be minimal attrition rate based on subjects being unable to complete the protocol. In the case of attrition, patients will be interviewed for contributory sources.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Change</measure>
      <time_frame>through last training visit (weeks 1-6, 12 sessions)</time_frame>
      <description>Patients will be questioned at the beginning of each session about potential AEs and any AEs observed during sessions by the therapists will be recorded at each training session. The expectation is that there will be no uncorrected and unacceptable AEs as captured by regular structured interviews.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Six-minute Walk Test (Suitability as a Future Primary Efficacy Measure) Change</measure>
      <time_frame>through last training visit (weeks 1-6, 12 sessions) and 6- and 12-wks post-training</time_frame>
      <description>The suitability of the 6MWT as a future primary clinical outcome measure (and our secondary measures) will be determined from the therapists' impression of ease and reliability of usage and from anticipated trends in scoring improvement. The outcomes here from the 6MWT and secondary measures will be further used towards powering for a future clinical efficacy study, while accounting for preliminary defined influences of severity of PD (H&amp;Y Staging) and cognition (MOCA scoring). Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Satisfaction</measure>
      <time_frame>immediate post-training</time_frame>
      <description>All subjects will be interviewed for patient satisfaction with wearing and training with the exoskeleton.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Motor examination (Part III) of the modified Unified Parkinson's Disease Rating Scale (Suitability as a Future Secondary Efficacy Measure)</measure>
      <time_frame>immediate post-training, 6- and 12-wks post-training</time_frame>
      <description>Will assess the suitability of the modified UPDRS Part III (nl = 0, max. 128) as a future secondary clinical outcome measure. Will be collected at baseline and end of training. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Berg Balance Scale (Suitability as a Future Secondary Efficacy Measure)</measure>
      <time_frame>immediate post-training, 6- and 12-wks post-training</time_frame>
      <description>Will assess the suitability of BBS (0 (worst) to 56 (best)) as a future secondary clinical outcome measure, focused on balance. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motion Detector Sensors (Suitability as a Future Secondary Efficacy Measure)</measure>
      <time_frame>through last training visit (weeks 1-6, 12 sessions) and 6- and 12-wks post-training</time_frame>
      <description>Lightweight motion sensors will be attached to the exoskeleton on each leg to assess their suitability as future objective secondary clinical outcome measures of such gait parameters, as freezing of gait. Will be collected at each training visit. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The University of Alabama at Birmingham Study of Aging Life-Space Assessment (Suitability as a Future Secondary Efficacy Measure)</measure>
      <time_frame>immediate post-training, 6- and 12-wks post-training</time_frame>
      <description>Will assess the suitability of The UAB Study of Aging LSA (0 (worst) to 120 (best)) as a future secondary clinical outcome measure, focused on functional mobility. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Parkinson's Disease</condition>
    <arm_group>
      <arm_group_label>Feasibility and Safety</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>This is a feasibility study to assess the safety and potential utility of a lightweight ground exoskeleton (Keeogo, B-Temia, Inc.) to enhance mobility in people with Parkinson's disease (PD).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Exoskeleton</intervention_name>
      <description>lightweight ground exoskeleton</description>
      <arm_group_label>Feasibility and Safety</arm_group_label>
      <other_name>Keeogo</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  PD confirmed by a PADRECC movement disorder specialist using UK Brain Bank Criteria&#xD;
  &#xD;
            -  Modified H&amp;Y stage II-V&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  neurological, musculoskeletal, or other disorders unrelated to PD contributing to&#xD;
               impairment of stance, gait, balance or coordination&#xD;
  &#xD;
            -  severe CHF, COPD, or those requiring nasal canula O2&#xD;
  &#xD;
            -  history of implantable cardiac device or ablative surgery&#xD;
  &#xD;
            -  moderately-severe to severe cognitive impairment / dementia (Montreal Cognitive&#xD;
               Assessment &lt; 17/30)&#xD;
  &#xD;
            -  symptomatic orthostatic hypotension with exertion&#xD;
  &#xD;
            -  feeding tube or associated port placement (PEG/J-PEG)&#xD;
  &#xD;
            -  body height less than 5'1&quot; or greater than 6'3&quot;&#xD;
  &#xD;
            -  body weight greater than 250 pounds&#xD;
  &#xD;
            -  amputation of any portion of the lower limbs&#xD;
  &#xD;
            -  osteoporosis as defined by DEXA Scan T score &lt; -2.5&#xD;
  &#xD;
            -  failure to meet B-Temia-established hip and knee flexion and extension manual muscle&#xD;
               test (MMT) prerequisite screening parameters, which assure that individuals can&#xD;
               adequately engage and walk against the resistive forces of the Keeogo&#xD;
  &#xD;
            -  inability to complete 20 minutes of walking with the exoskeleton (over a maximum&#xD;
               period of one hour) at the initial screening/testing session&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark S Baron, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hunter Holmes McGuire VA Medical Center, Richmond, VA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jose F Huizar, MD</last_name>
      <phone>(804) 675-5444</phone>
      <email>Jose.Huizar2@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alyssa Huizar</last_name>
      <phone>(804) 675-5151</phone>
      <email>alyssa.huizar@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hunter Holmes McGuire VA Medical Center, Richmond, VA</name>
        <address>
          <city>Richmond</city>
          <state>Virginia</state>
          <zip>23249-0001</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jose F Huizar, MD</last_name>
        <phone>804-675-5444</phone>
        <email>Jose.Huizar2@va.gov</email>
      </contact>
      <investigator>
        <last_name>Mark S Baron, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>exoskeleton</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</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/NCT06028529
  org study id: N4387-P
  nct id: NCT06028529
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Physical therapy approaches for balance and walking deficits in Parkinson's disease (PD) have
        limited effectiveness, with mostly short-lasting benefits. An exoskeleton is a device that
        straps to the legs and provides a passive force to assist people to better ambulate. The goal
        of this study is to establish the feasibility and safety of a lightweight exoskeleton on
        mobility and fall reduction in people with PD. As most PD patients eventually require
        assistive mobility devices, the exoskeleton represents a new option for increased, mobility,
        quality of life, and independence. Qualified subjects will come to the clinic twice weekly
        for six weeks (12 total visits) and wear the exoskeleton device while walking under the
        supervision of a trained physical therapist. Study staff will also interview participants and
        assess their PD symptoms, quality of life, and overall mobility. This study hopes to
        establish exoskeletons as modern, standard of care devices, which allow people with PD to
        maintain more independent and productive lives.
  Currently, progressive resistance exercise training, high intensity treadmill training,
        balanced-based perturbation, and standard physical exercises are utilized to treat mobility
        deficits associated with PD; however, the effectiveness of these therapies is limited. This
        study proposes to investigate the utility of a portable exoskeleton for people with PD. The
        goal is to establish the safety of a lightweight portable exoskeleton, the Keeogo, for gait
        training and to preliminarily assess its potential efficacy for gait mobility and fall
        reduction. As the vast majority of PD patients eventually require assistive mobility devices,
        portable exoskeletons represents an avenue for increased, mobility, quality of life, and
        independence. Robotic-assist gait training (RAGT) has been extensively applied as a
        remarkable therapeutic modality, such that it is enabling highly motivated people with
        devastating neurologic injuries to regain independent ambulation. Despite the potential for
        this technology to transform the lives of people with PD, these devices are not being
        adequately investigated in people with movement disorders.
  
        To establish preliminary safety and efficiency of the Keeogo exoskeleton for PD patients at
        various disease stages, the investigators will examine representative subjects in Hohen &
        Yahr stages II, III, IV, and V. Inclusion criteria are: 1) PD confirmed by a PADRECC movement
        disorder specialist using UK Brain Bank Criteria, 2) Modified H&Y stage II-V. Exclusion
        criteria are: 1) neurological, musculoskeletal, or other disorders unrelated to PD
        contributing to impairment of stance, gait, balance or coordination, 2) severe CHF, COPD, or
        those requiring nasal canula O2, 3) history of implantable cardiac device or ablative
        surgery, 4) moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment
        < 17/30), 5) symptomatic orthostatic hypotension with exertion, 6) feeding tube or associated
        port placement (PEG/J-PEG), 7) body height less than 5'1" or greater than 6'3" 8) body weight
        greater than 250 pounds, and 9) amputation of any portion of the lower limbs. Subjects will
        participate in a total of 30 minutes RAGT ambulation with the Keeogo twice per week for 6
        weeks (12 sessions). Subjects may opt to utilize a platform rolling walker, rolling walker,
        bilateral Lofstrand crutches or a unilateral device, such as a cane or Lofstrand crutch, and
        will be maintained throughout the intervention.
  
        To establish safety, the number and severity of AEs, such as falls, discomfort, skin or
        musculoskeletal injury, and orthostatic hypotensive episodes will be documented. Intervention
        efficacy will be measured pre- and post-donning of the Keeogo exoskeleton at bi-weekly
        intervention visits, and at a 6-week post-study visit. Walking capacity, including benefits
        on FoG, will be assessed with the Six Minute Walk Test (6MWT), balance and postural stability
        with the Berg Balance Scale (BBS), and disease severity with the Examination, Part III, of
        the Unified Parkinson's Disease Rating Scale (UPDRS). Additional assessments will include
        Berg Balance Scale (BBS), ascending and descending stair climb, PDQ39, The University of
        Alabama at Birmingham (UAB) Study of Aging Life-Space Assessment (LSA), and PD-Carer. As a
        primary end point for establishing efficacy, the 6MWT will be compared between end of
        training and baseline (with and without the exoskeleton), as well as at 6 and 12 weeks
        post-study as a durability assessment towards establishing a need for future assessment of
        in-home usage. These pilot investigations are expected to lay the groundwork for a large
        multi-center clinical study to establish ground exoskeletons as modern, standard of care
        devices to aid Veterans and other people with PD and other disabling movement disorders to
        maintain a more normal and productive life.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Safety, tolerability, feasibility, methodological assessment, and sample characteristics with consideration of multiple staging and high patient variability towards the design of a future clinical efficacy study.
  primary purpose: Other
  masking: None (Open Label)
  measure: Incidence of Falls While Wearing the Exoskeleton (Safety and Tolerability) Change
  time frame: Through last training visit (weeks 1-6, 12 sessions)
  description: Patients will be continuously supervised by a trained physical therapist and the expectation is that there will be no falls while wearing the device. All primary safety and tolerability measures will be separately assessed with consideration of H&Y staging (2-4; max. 5) and cognition (based on MOCA scores 0 = nl, max. 30).
  -Minimal attrition rate based on subjects being unable to complete the protocol. This could for example establish that the Keeogo device is not tolerated by more advanced (H&Y Stage 5) patients, but is acceptable for others.
  measure: Incidence of Attrition (Tolerability) Change
  time frame: Through last training visit (weeks 1-6, 12 sessions)
  description: The expectation is that there will be minimal attrition rate based on subjects being unable to complete the protocol. In the case of attrition, patients will be interviewed for contributory sources.
  measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Change
  time frame: through last training visit (weeks 1-6, 12 sessions)
  description: Patients will be questioned at the beginning of each session about potential AEs and any AEs observed during sessions by the therapists will be recorded at each training session. The expectation is that there will be no uncorrected and unacceptable AEs as captured by regular structured interviews.
  measure: Six-minute Walk Test (Suitability as a Future Primary Efficacy Measure) Change
  time frame: through last training visit (weeks 1-6, 12 sessions) and 6- and 12-wks post-training
  description: The suitability of the 6MWT as a future primary clinical outcome measure (and our secondary measures) will be determined from the therapists' impression of ease and reliability of usage and from anticipated trends in scoring improvement. The outcomes here from the 6MWT and secondary measures will be further used towards powering for a future clinical efficacy study, while accounting for preliminary defined influences of severity of PD (H&Y Staging) and cognition (MOCA scoring). Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.
  measure: Patient Satisfaction
  time frame: immediate post-training
  description: All subjects will be interviewed for patient satisfaction with wearing and training with the exoskeleton.
  measure: Motor examination (Part III) of the modified Unified Parkinson's Disease Rating Scale (Suitability as a Future Secondary Efficacy Measure)
  time frame: immediate post-training, 6- and 12-wks post-training
  description: Will assess the suitability of the modified UPDRS Part III (nl = 0, max. 128) as a future secondary clinical outcome measure. Will be collected at baseline and end of training. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.
  measure: Berg Balance Scale (Suitability as a Future Secondary Efficacy Measure)
  time frame: immediate post-training, 6- and 12-wks post-training
  description: Will assess the suitability of BBS (0 (worst) to 56 (best)) as a future secondary clinical outcome measure, focused on balance. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.
  measure: Motion Detector Sensors (Suitability as a Future Secondary Efficacy Measure)
  time frame: through last training visit (weeks 1-6, 12 sessions) and 6- and 12-wks post-training
  description: Lightweight motion sensors will be attached to the exoskeleton on each leg to assess their suitability as future objective secondary clinical outcome measures of such gait parameters, as freezing of gait. Will be collected at each training visit. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.
  measure: The University of Alabama at Birmingham Study of Aging Life-Space Assessment (Suitability as a Future Secondary Efficacy Measure)
  time frame: immediate post-training, 6- and 12-wks post-training
  description: Will assess the suitability of The UAB Study of Aging LSA (0 (worst) to 120 (best)) as a future secondary clinical outcome measure, focused on functional mobility. Additionally, 6- and 12-weeks post-training assessments will be used to preliminarily assess the durability of training effects.
  arm group label: Feasibility and Safety
  arm group type: Other
  description: This is a feasibility study to assess the safety and potential utility of a lightweight ground exoskeleton (Keeogo, B-Temia, Inc.) to enhance mobility in people with Parkinson's disease (PD).
  intervention type: Device
  intervention name: Exoskeleton
  description: lightweight ground exoskeleton
  arm group label: Feasibility and Safety
  other name: Keeogo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Mark S Baron, MD
  role: Principal Investigator
  affiliation: Hunter Holmes McGuire VA Medical Center, Richmond, VA
  last name: Jose F Huizar, MD
  phone: (804) 675-5444
  email: Jose.Huizar2@va.gov
  last name: Alyssa Huizar
  phone: (804) 675-5151
  email: alyssa.huizar@va.gov
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: No