<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/NCT03790644</url>
  </required_header>
  <id_info>
    <org_study_id>XO-Nof1-RCT-RG2019</org_study_id>
    <nct_id>NCT03790644</nct_id>
  </id_info>
  <brief_title>Powered Assist to Improve Ambulation in Severe Lung Disease</brief_title>
  <acronym>REVIVE</acronym>
  <official_title>Assistive Device to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease - Evaluated Using a Single-Case Series Experimental Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Park Healthcare Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Park Healthcare Centre</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>
      Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide&#xD;
      with disabling consequences. Many with a compromised respiratory system cannot support the&#xD;
      metabolic energy demands of walking causing them to walk slowly and stop often. Those with&#xD;
      CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes&#xD;
      part of the energy of walking. Assisting the legs will lower the metabolic energy demands,&#xD;
      and therefore the ventilation required for exercise, thereby allowing them to walk faster and&#xD;
      further. Proposed is a series of single-case experiments comparing walking endurance with and&#xD;
      without a powered exoskeleton assist. The aim of this study is to determine the efficacy of&#xD;
      an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton&#xD;
      could be a novel immediate and long term strategy to augment walking as part of the spectrum&#xD;
      of pulmonary rehabilitation and community reintegration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">May 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>A prospective longitudinal, self-controlled, single-case repeated measures alternating treatment, randomized and counterbalanced cross-over experimental trial design, comparing walking endurance without and with a powered exoskeleton.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>walking endurance time</measure>
    <time_frame>an average of 7 tests over 4 weeks</time_frame>
    <description>tolerance (time) of an individualized constant, brisk, walking speed endurance test</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Lung Disease Chronic</condition>
  <arm_group>
    <arm_group_label>exoskeleton assist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>walking with assist of a powered exoskeleton</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>exoskeleton assist</intervention_name>
    <description>A powered exoskeleton describes a wearable robot designed around the shape and function of the human body with segments and joints externally coupled to those of the user. The exoskeleton includes a rigid outer frame, sensors that detect a user's desired movements, a computerized controller, motors and actuators, and lightweight batteries.&#xD;
The exoskeleton is designed to be worn in the community.</description>
    <arm_group_label>exoskeleton assist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable chronic respiratory disease&#xD;
&#xD;
          -  modified medical research council dyspnoea score (mMRC) ≥ 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  evidence of cardiac rhythm or circulatory compromise&#xD;
&#xD;
          -  myocardial infarct within the previous three months&#xD;
&#xD;
          -  moderate-severe aortic stenosis&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  sustained cardiac arrhythmias&#xD;
&#xD;
          -  untreated neoplasia&#xD;
&#xD;
          -  lung surgery within the previous three months&#xD;
&#xD;
          -  any other predominant co-morbidities or treatments that might influence walk testing&#xD;
&#xD;
          -  body size outside of exoskeleton fit specifications&#xD;
&#xD;
          -  skin sores or skin breakdown in the area where the device is worn&#xD;
&#xD;
          -  a high risk of fracture&#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>Roger S Goldstein</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Park Healthcare Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westpark Health Care Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6M 2J5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Dolmage TE, Goldstein RS. Assisting Walking in Patients with Chronic Respiratory Disease Using a Powered Exoskeleton: A Series of N-of-1 Clinical Trials. Ann Am Thorac Soc. 2022 Jul;19(7):1230-1232. doi: 10.1513/AnnalsATS.202201-045RL. No abstract available.</citation>
    <PMID>35348445</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Park Healthcare Centre</investigator_affiliation>
    <investigator_full_name>Roger Goldstein</investigator_full_name>
    <investigator_title>Director, Program in Respiratory Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>Walking</keyword>
  <keyword>Exoskeleton Device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data (IPD) will not be available to other researchers.</ipd_description>
  </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/NCT03790644
org study id: XO-Nof1-RCT-RG2019
nct id: NCT03790644
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide
      with disabling consequences. Many with a compromised respiratory system cannot support the
      metabolic energy demands of walking causing them to walk slowly and stop often. Those with
      CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes
      part of the energy of walking. Assisting the legs will lower the metabolic energy demands,
      and therefore the ventilation required for exercise, thereby allowing them to walk faster and
      further. Proposed is a series of single-case experiments comparing walking endurance with and
      without a powered exoskeleton assist. The aim of this study is to determine the efficacy of
      an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton
      could be a novel immediate and long term strategy to augment walking as part of the spectrum
      of pulmonary rehabilitation and community reintegration.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A prospective longitudinal, self-controlled, single-case repeated measures alternating treatment, randomized and counterbalanced cross-over experimental trial design, comparing walking endurance without and with a powered exoskeleton.
primary purpose: Treatment
masking: None (Open Label)
measure: walking endurance time
time frame: an average of 7 tests over 4 weeks
description: tolerance (time) of an individualized constant, brisk, walking speed endurance test
arm group label: exoskeleton assist
arm group type: Experimental
description: walking with assist of a powered exoskeleton
intervention type: Device
intervention name: exoskeleton assist
description: A powered exoskeleton describes a wearable robot designed around the shape and function of the human body with segments and joints externally coupled to those of the user. The exoskeleton includes a rigid outer frame, sensors that detect a user's desired movements, a computerized controller, motors and actuators, and lightweight batteries.
The exoskeleton is designed to be worn in the community.
arm group label: exoskeleton assist
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roger S Goldstein
role: Principal Investigator
affiliation: West Park Healthcare Centre
facility: 
country: Canada
citation: Dolmage TE, Goldstein RS. Assisting Walking in Patients with Chronic Respiratory Disease Using a Powered Exoskeleton: A Series of N-of-1 Clinical Trials. Ann Am Thorac Soc. 2022 Jul;19(7):1230-1232. doi: 10.1513/AnnalsATS.202201-045RL. No abstract available.
PMID: 35348445
responsible party type: Principal Investigator
investigator affiliation: West Park Healthcare Centre
investigator full name: Roger Goldstein
investigator title: Director, Program in Respiratory Rehabilitation
mesh term: Lung Diseases
sharing ipd: No
ipd description: Individual participant data (IPD) will not be available to other researchers.