<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/NCT01690910</url>
  </required_header>
  <id_info>
    <org_study_id>RCAY 40</org_study_id>
    <nct_id>NCT01690910</nct_id>
  </id_info>
  <brief_title>Effects of Mobility Devices on Nursing Compliance With Mobility Protocols</brief_title>
  <acronym>EMS</acronym>
  <official_title>Effects of Mobility Devices on Nursing Compliance With Mobility Protocols.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Joseph Mercy Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint Joseph Mercy Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 10-week pilot study for a randomized non-blinded controlled clinical trial to&#xD;
      assess whether use of the Rifton Gait Trainer will improve the incidence of mobilization of&#xD;
      critically ill ventilator dependent patients in the intensive care units (ICUs) and improve&#xD;
      important patient outcomes. The pilot study is designed to assess the feasibility and&#xD;
      logistics of doing a study of this nature in the ICU; it will also provide the means to&#xD;
      obtain estimates of outcome effect sizes, number of repeated measures, time between repeated&#xD;
      measures, and intra-subject and intra-unit correlations, to be used for sample size&#xD;
      calculations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Critical care costs an estimated 90 billion dollars per year in the United States,&#xD;
      comprising approximately 1% of the gross national product.1 Though this expenditure is&#xD;
      enormous, together with advances in critical care medicine and mechanical ventilation&#xD;
      technology, it has produced a priceless trend in decreasing intensive care unit (ICU)&#xD;
      mortality.1 Of all ICU admissions, about 40% require mechanical ventilation, often with&#xD;
      accompanying necessary periods of sedation and inactivity.1 Although more patients are&#xD;
      surviving their ICU stay, it is becoming apparent that our current ICU culture of heavy&#xD;
      sedation and inactivity is taking its toll on the complete recovery of the critically ill&#xD;
      patient. 1,2 Several studies have shown significant disability one year after discharge, as&#xD;
      well as major declines in functional status and health-related quality of life; half of ICU&#xD;
      patients were unable to return to work due to persistent fatigue, weakness, and poor&#xD;
      functional status. 4 The primary contributor was muscle wasting and weakness,5 due to the&#xD;
      prolonged immobilization brought about by illness, lengthy bed rest, deep sedation, and the&#xD;
      use of paralytic agents.6 It is estimated that just a single day of inactivity causes muscle&#xD;
      strength to decrease by 1-1.5%.7 Although 94% of survivors with critical illness&#xD;
      myoneuropathy can demonstrate meaningful clinical recovery of muscle strength 9 months out&#xD;
      from their hospital stay, there are still some patients whose weakness may persist, resulting&#xD;
      in severe and prolonged functional deficits.14,18 To combat the deleterious effects of&#xD;
      inactivity and improve complete recovery, some hospitals have instituted programs under the&#xD;
      rubric early mobility, wherein sedation is reduced and patients are engaged in progressive&#xD;
      levels of activity as soon as physically possible. Early mobilization starts with passive&#xD;
      range of motion exercises, then progresses to active range of motion, sitting, standing, and,&#xD;
      finally, walking. Early mobility in the ICU has been proposed as a crucial instrument in&#xD;
      muscle preservation and protection from neuropathy of critical illness, thereby decreasing&#xD;
      long-term morbidity and physical debilitation.18&#xD;
&#xD;
      There is a growing body of evidence indicating that early mobilization of ventilated patients&#xD;
      can have a significant positive impact on length of stay, muscle condition, and the patient's&#xD;
      overall sense of well-being. The use of early mobility in patients with respiratory failure&#xD;
      has been proven safe with the implementation of proper monitoring in a physiologically stable&#xD;
      and awake patient.2 Hopkins et al. implemented an early activity program and demonstrated a&#xD;
      decline in length of ICU stay of 3 days.1 Morris et al. implemented a similar early&#xD;
      mobilization program that showed a statistically significant decrease in the length of stay&#xD;
      in the ICU (6.9 vs. 5.5 days, P=0.025) as well as in the hospital (14.5 vs. 11.2 days,&#xD;
      P=0.006); in addition there was a notable trend towards decreased inpatient cost per patient&#xD;
      ($44,302 vs. $41,142, P=0.262).19 Schweikert et al. were able to demonstrate that patients&#xD;
      who had undergone early mobilization had a greater rate of return to independent functional&#xD;
      status at hospital discharge (59% vs. 35%, P=0.02).20 These studies have demonstrated the&#xD;
      ability to increase mobilization, improve physical function, and decrease ICU resource&#xD;
      utilization within a relatively short period of time with an appropriate change in routine&#xD;
      clinical practice.12&#xD;
&#xD;
      Unfortunately, there exist significant barriers to the implementation of an early mobility&#xD;
      program. The most significant and pervasive of these barriers is cultural-the perception that&#xD;
      the critically ill patient cannot tolerate physical activity. This barrier, however, is&#xD;
      rapidly dissolving with the mounting evidence noted above. The demonstrated benefits of early&#xD;
      mobility have prompted increasing numbers of institutions to develop their own early mobility&#xD;
      protocols and attempt their implementation. Once the cultural barriers are overcome, however,&#xD;
      additional barriers appear. Thus, implementation has been slow and spotty. In a multisite&#xD;
      study, only 27% of patients with acute lung injury received any form of physical therapy in&#xD;
      the ICU, with treatments occurring only 6% of those days.22 These barriers involved: 1)&#xD;
      providing safety guarantees, 2) accommodating staffing models, and 3) finding the right&#xD;
      hardware. With regard to safety guarantees, there exist legitimate fears regarding possible&#xD;
      harm to the patient in the process of mobilization, either secondary to patient falls, or&#xD;
      unintentional removal of lines, feeding or drainage tubes, or endotracheal tubes. Safe&#xD;
      mechanical support is needed for the patient, to the point of full body-weight support. The&#xD;
      staffing model is also critical: the mobilization of one ventilated patient requires, in&#xD;
      addition to a physical therapist, at least three staff members to move medical equipment&#xD;
      while the patient walks.11, 21 Although on a given day, within a 20-bed ICU, only two&#xD;
      patients might qualify for assisted walking, and would require only four 15-minute periods&#xD;
      from a 5-member mobility team per day, the logistics of assembling that team from the ICU&#xD;
      staff are often prohibitive. Finally with regard to finding appropriate hardware, the&#xD;
      management and transport of medical equipment alongside the walking patient is not easily&#xD;
      addressed with rolling poles and carts. The current standard of care for walking a&#xD;
      mechanically ventilated patient consists of a wheeled walker held onto by the patient, the&#xD;
      patient supported with a gait belt held from behind by a physical therapist, and 4-5 staff&#xD;
      persons in attendance to guide the patient, roll the equipment, and be ready to &quot;pick up&quot;&#xD;
      should the patient fall.&#xD;
&#xD;
      As an alternative to the front-wheeled walker, the Rifton Gait Trainer has been introduced&#xD;
      into clinical practice. This device provides greater inherent safety features via a pelvic&#xD;
      harness that keeps the patient from falling, even if their legs should give out while&#xD;
      walking. In addition, there is a chest piece to keep patients from tipping forward or&#xD;
      backward, and there are higher handholds to help patients mobilize more easily. The Rifton&#xD;
      Gait Trainer addresses two of the three above listed barriers by providing more inherent&#xD;
      safety features through better hardware, and it may also help decrease the number of staff&#xD;
      required to mobilize patients.&#xD;
&#xD;
      Purpose The following sections describe a 10-week pilot study for a randomized non-blinded&#xD;
      controlled clinical trial to assess whether use of the Rifton Gait Trainer will improve the&#xD;
      incidence of mobilization of critically ill ventilator dependent patients in the intensive&#xD;
      care units (ICUs) and improve important patient outcomes. The pilot study is designed to&#xD;
      assess the feasibility and logistics of doing a study of this nature in the ICU; it will also&#xD;
      provide the means to obtain estimates of outcome effect sizes, number of repeated measures,&#xD;
      time between repeated measures, and intra-subject and intra-unit correlations, to be used for&#xD;
      sample size calculations for a multi-center study.&#xD;
&#xD;
      Subjects Approximately forty subjects will be randomized to use either the RGT or the FWW,&#xD;
      with enrollment spanning a period of approximately 10 weeks. Patients will be deemed eligible&#xD;
      to ambulate based on their daily mobility score, as calculated according to the Early&#xD;
      Mobility Protocol. Mobility scores are first determined based on level of consciousness. The&#xD;
      unconscious patient has the lowest mobility level, Level 1. Patients who are conscious but&#xD;
      have a low RASS score (-2) are considered a Level 2. Conscious patients are considered to be&#xD;
      Level 3 or 4. Level 4 patients are those patients who have proven that they can master all&#xD;
      the activities outlined for Level 3 mobility; that is, they can dangle at the bedside and&#xD;
      stand and pivot to a chair. Level 4 activities are separated from Level 3 activities only by&#xD;
      the ability to walk in the hallway.&#xD;
&#xD;
      Informed consent will occur prior to randomization. Randomization will occur when patients&#xD;
      have been on the ventilator &gt; 2 days and have mobility scores eligible for walking.&#xD;
      Randomization will be assigned on a 1:1 ratio to either the RGT or FWW. Patients will be&#xD;
      randomized using a web-based system called CREDIT.&#xD;
&#xD;
      Data Analysis A future study will be considered feasible if we are able to enroll 60% of&#xD;
      eligible patients, have records for 90% of eligible ambulation days, and at least 85% of&#xD;
      required data fields are completed as designed. Analysis will be based on intention-to-treat;&#xD;
      that is, regardless of which walker is actually used, the patient will be analyzed in the&#xD;
      group to which he or she was randomized.&#xD;
&#xD;
      The primary outcome measure, how many times the patient is mobilized each day, will be&#xD;
      compared between devices using a hierarchical generalized linear model with number of times&#xD;
      the patient is mobilized each day as the dependent variable, device, unit and day and an&#xD;
      interaction of device with day as the independent variables, and subject as the random effect&#xD;
      in the model. Most likely, ordinal regression will be used with 0, 1, 2 or more times as the&#xD;
      definition of outcome. If there are too few occurrences of 2 or more, we will convert to a&#xD;
      logistic model. If one device is better than the other, we would expect the odds of being&#xD;
      mobilized at a higher level with RGT is significantly different from the odds of being&#xD;
      mobilized with FWW. We will also test for the interaction of device with time.&#xD;
&#xD;
      Sources&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Patient enrollment to low to support an analysis&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Total Number of Times the Critically Ill Ventilator Dependent Patient is Mobilized.</measure>
    <time_frame>Duration of Intensive Care Unit Stay (2-30 days)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Time the Critically Ill Ventilator Dependent Patient is Mobilized.</measure>
    <time_frame>Patient weight baring to patient seated (1-12 minutes)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Mobility Limitations</condition>
  <arm_group>
    <arm_group_label>Front Wheeled Walker</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Front Wheeled Walker is a standard walker that is used to assist patients while walking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rifton Gait Trainer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rifton Gait Trainer</intervention_name>
    <arm_group_label>Rifton Gait Trainer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Front Wheeled Walker</intervention_name>
    <arm_group_label>Front Wheeled Walker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  On the ventilator for &gt; 48 hours&#xD;
&#xD;
          -  Mobility score &gt; 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &gt; 220 lbs&#xD;
&#xD;
          -  Limb amputees&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant women&#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>MaryAnne Purtill, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jospeh Mercy Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hopkins RO, Spuhler VJ, Thomsen GE. Transforming ICU culture to facilitate early mobility. Crit Care Clin. 2007 Jan;23(1):81-96. doi: 10.1016/j.ccc.2006.11.004.</citation>
    <PMID>17307118</PMID>
  </reference>
  <reference>
    <citation>Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. doi: 10.1097/01.CCM.0000251130.69568.87.</citation>
    <PMID>17133183</PMID>
  </reference>
  <reference>
    <citation>Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.</citation>
    <PMID>12594312</PMID>
  </reference>
  <reference>
    <citation>Needham DM, Korupolu R, Zanni JM, Pradhan P, Colantuoni E, Palmer JB, Brower RG, Fan E. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. doi: 10.1016/j.apmr.2010.01.002.</citation>
    <PMID>20382284</PMID>
  </reference>
  <reference>
    <citation>Fan E, Zanni JM, Dennison CR, Lepre SJ, Needham DM. Critical illness neuromyopathy and muscle weakness in patients in the intensive care unit. AACN Adv Crit Care. 2009 Jul-Sep;20(3):243-53. doi: 10.1097/NCI.0b013e3181ac2551.</citation>
    <PMID>19638746</PMID>
  </reference>
  <reference>
    <citation>Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008 Oct 8;300(14):1685-90. doi: 10.1001/jama.300.14.1685.</citation>
    <PMID>18840842</PMID>
  </reference>
  <reference>
    <citation>Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.</citation>
    <PMID>18596631</PMID>
  </reference>
  <reference>
    <citation>Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.</citation>
    <PMID>19446324</PMID>
  </reference>
  <reference>
    <citation>Needham DM, Wang W, Desai SV, Mendez-Tellez PA, Dennison CR, Sevransky J, Shanholtz C, Ciesla N, Spillman K, Pronovost PJ. Intensive care unit exposures for long-term outcomes research: development and description of exposures for 150 patients with acute lung injury. J Crit Care. 2007 Dec;22(4):275-84. doi: 10.1016/j.jcrc.2007.02.001. Epub 2007 Jun 27.</citation>
    <PMID>18086397</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>March 19, 2021</results_first_submitted>
  <results_first_submitted_qc>March 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2021</results_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ventilator</keyword>
  <keyword>Mobility Limitations</keyword>
  <keyword>Critical Care</keyword>
  <keyword>Rifton Gait Trainer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mobility Limitation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Front Wheeled Walker</title>
          <description>The Front Wheeled Walker is a standard walker that is used to assist patients while walking.&#xD;
Front Wheeled Walker</description>
        </group>
        <group group_id="P2">
          <title>Rifton Gait Trainer</title>
          <description>The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.&#xD;
Rifton Gait Trainer</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">The study was never completed due to feasibility issues.</participants>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The study was never completed due to feasibility issues.</population>
      <group_list>
        <group group_id="B1">
          <title>Front Wheeled Walker</title>
          <description>The Front Wheeled Walker is a standard walker that is used to assist patients while walking.&#xD;
Front Wheeled Walker</description>
        </group>
        <group group_id="B2">
          <title>Rifton Gait Trainer</title>
          <description>The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.&#xD;
Rifton Gait Trainer</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Number of Times the Critically Ill Ventilator Dependent Patient is Mobilized.</title>
        <time_frame>Duration of Intensive Care Unit Stay (2-30 days)</time_frame>
        <population>The study was never completed due to feasibility issues.</population>
        <group_list>
          <group group_id="O1">
            <title>Front Wheeled Walker</title>
            <description>The Front Wheeled Walker is a standard walker that is used to assist patients while walking.&#xD;
Front Wheeled Walker</description>
          </group>
          <group group_id="O2">
            <title>Rifton Gait Trainer</title>
            <description>The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.&#xD;
Rifton Gait Trainer</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Times the Critically Ill Ventilator Dependent Patient is Mobilized.</title>
          <population>The study was never completed due to feasibility issues.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Time the Critically Ill Ventilator Dependent Patient is Mobilized.</title>
        <time_frame>Patient weight baring to patient seated (1-12 minutes)</time_frame>
        <population>The study was never completed due to feasibility issues.</population>
        <group_list>
          <group group_id="O1">
            <title>Front Wheeled Walker</title>
            <description>The Front Wheeled Walker is a standard walker that is used to assist patients while walking.&#xD;
Front Wheeled Walker</description>
          </group>
          <group group_id="O2">
            <title>Rifton Gait Trainer</title>
            <description>The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.&#xD;
Rifton Gait Trainer</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Time the Critically Ill Ventilator Dependent Patient is Mobilized.</title>
          <population>The study was never completed due to feasibility issues.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Not applicable; study was never started</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Front Wheeled Walker</title>
          <description>The Front Wheeled Walker is a standard walker that is used to assist patients while walking.&#xD;
Front Wheeled Walker</description>
        </group>
        <group group_id="E2">
          <title>Rifton Gait Trainer</title>
          <description>The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.&#xD;
Rifton Gait Trainer</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Amy Burghardt</name_or_title>
      <organization>St. Joseph Mercy Hospital</organization>
      <phone>734-712-2027</phone>
      <email>amy.burghardt@stjoeshealth.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01690910
org study id: RCAY 40
nct id: NCT01690910
lead sponsor: 
has dmc: No
This is a 10-week pilot study for a randomized non-blinded controlled clinical trial to
      assess whether use of the Rifton Gait Trainer will improve the incidence of mobilization of
      critically ill ventilator dependent patients in the intensive care units (ICUs) and improve
      important patient outcomes. The pilot study is designed to assess the feasibility and
      logistics of doing a study of this nature in the ICU; it will also provide the means to
      obtain estimates of outcome effect sizes, number of repeated measures, time between repeated
      measures, and intra-subject and intra-unit correlations, to be used for sample size
      calculations.
Background Critical care costs an estimated 90 billion dollars per year in the United States,
      comprising approximately 1% of the gross national product.1 Though this expenditure is
      enormous, together with advances in critical care medicine and mechanical ventilation
      technology, it has produced a priceless trend in decreasing intensive care unit (ICU)
      mortality.1 Of all ICU admissions, about 40% require mechanical ventilation, often with
      accompanying necessary periods of sedation and inactivity.1 Although more patients are
      surviving their ICU stay, it is becoming apparent that our current ICU culture of heavy
      sedation and inactivity is taking its toll on the complete recovery of the critically ill
      patient. 1,2 Several studies have shown significant disability one year after discharge, as
      well as major declines in functional status and health-related quality of life; half of ICU
      patients were unable to return to work due to persistent fatigue, weakness, and poor
      functional status. 4 The primary contributor was muscle wasting and weakness,5 due to the
      prolonged immobilization brought about by illness, lengthy bed rest, deep sedation, and the
      use of paralytic agents.6 It is estimated that just a single day of inactivity causes muscle
      strength to decrease by 1-1.5%.7 Although 94% of survivors with critical illness
      myoneuropathy can demonstrate meaningful clinical recovery of muscle strength 9 months out
      from their hospital stay, there are still some patients whose weakness may persist, resulting
      in severe and prolonged functional deficits.14,18 To combat the deleterious effects of
      inactivity and improve complete recovery, some hospitals have instituted programs under the
      rubric early mobility, wherein sedation is reduced and patients are engaged in progressive
      levels of activity as soon as physically possible. Early mobilization starts with passive
      range of motion exercises, then progresses to active range of motion, sitting, standing, and,
      finally, walking. Early mobility in the ICU has been proposed as a crucial instrument in
      muscle preservation and protection from neuropathy of critical illness, thereby decreasing
      long-term morbidity and physical debilitation.18

      There is a growing body of evidence indicating that early mobilization of ventilated patients
      can have a significant positive impact on length of stay, muscle condition, and the patient's
      overall sense of well-being. The use of early mobility in patients with respiratory failure
      has been proven safe with the implementation of proper monitoring in a physiologically stable
      and awake patient.2 Hopkins et al. implemented an early activity program and demonstrated a
      decline in length of ICU stay of 3 days.1 Morris et al. implemented a similar early
      mobilization program that showed a statistically significant decrease in the length of stay
      in the ICU (6.9 vs. 5.5 days, P=0.025) as well as in the hospital (14.5 vs. 11.2 days,
      P=0.006); in addition there was a notable trend towards decreased inpatient cost per patient
      ($44,302 vs. $41,142, P=0.262).19 Schweikert et al. were able to demonstrate that patients
      who had undergone early mobilization had a greater rate of return to independent functional
      status at hospital discharge (59% vs. 35%, P=0.02).20 These studies have demonstrated the
      ability to increase mobilization, improve physical function, and decrease ICU resource
      utilization within a relatively short period of time with an appropriate change in routine
      clinical practice.12

      Unfortunately, there exist significant barriers to the implementation of an early mobility
      program. The most significant and pervasive of these barriers is cultural-the perception that
      the critically ill patient cannot tolerate physical activity. This barrier, however, is
      rapidly dissolving with the mounting evidence noted above. The demonstrated benefits of early
      mobility have prompted increasing numbers of institutions to develop their own early mobility
      protocols and attempt their implementation. Once the cultural barriers are overcome, however,
      additional barriers appear. Thus, implementation has been slow and spotty. In a multisite
      study, only 27% of patients with acute lung injury received any form of physical therapy in
      the ICU, with treatments occurring only 6% of those days.22 These barriers involved: 1)
      providing safety guarantees, 2) accommodating staffing models, and 3) finding the right
      hardware. With regard to safety guarantees, there exist legitimate fears regarding possible
      harm to the patient in the process of mobilization, either secondary to patient falls, or
      unintentional removal of lines, feeding or drainage tubes, or endotracheal tubes. Safe
      mechanical support is needed for the patient, to the point of full body-weight support. The
      staffing model is also critical: the mobilization of one ventilated patient requires, in
      addition to a physical therapist, at least three staff members to move medical equipment
      while the patient walks.11, 21 Although on a given day, within a 20-bed ICU, only two
      patients might qualify for assisted walking, and would require only four 15-minute periods
      from a 5-member mobility team per day, the logistics of assembling that team from the ICU
      staff are often prohibitive. Finally with regard to finding appropriate hardware, the
      management and transport of medical equipment alongside the walking patient is not easily
      addressed with rolling poles and carts. The current standard of care for walking a
      mechanically ventilated patient consists of a wheeled walker held onto by the patient, the
      patient supported with a gait belt held from behind by a physical therapist, and 4-5 staff
      persons in attendance to guide the patient, roll the equipment, and be ready to "pick up"
      should the patient fall.

      As an alternative to the front-wheeled walker, the Rifton Gait Trainer has been introduced
      into clinical practice. This device provides greater inherent safety features via a pelvic
      harness that keeps the patient from falling, even if their legs should give out while
      walking. In addition, there is a chest piece to keep patients from tipping forward or
      backward, and there are higher handholds to help patients mobilize more easily. The Rifton
      Gait Trainer addresses two of the three above listed barriers by providing more inherent
      safety features through better hardware, and it may also help decrease the number of staff
      required to mobilize patients.

      Purpose The following sections describe a 10-week pilot study for a randomized non-blinded
      controlled clinical trial to assess whether use of the Rifton Gait Trainer will improve the
      incidence of mobilization of critically ill ventilator dependent patients in the intensive
      care units (ICUs) and improve important patient outcomes. The pilot study is designed to
      assess the feasibility and logistics of doing a study of this nature in the ICU; it will also
      provide the means to obtain estimates of outcome effect sizes, number of repeated measures,
      time between repeated measures, and intra-subject and intra-unit correlations, to be used for
      sample size calculations for a multi-center study.

      Subjects Approximately forty subjects will be randomized to use either the RGT or the FWW,
      with enrollment spanning a period of approximately 10 weeks. Patients will be deemed eligible
      to ambulate based on their daily mobility score, as calculated according to the Early
      Mobility Protocol. Mobility scores are first determined based on level of consciousness. The
      unconscious patient has the lowest mobility level, Level 1. Patients who are conscious but
      have a low RASS score (-2) are considered a Level 2. Conscious patients are considered to be
      Level 3 or 4. Level 4 patients are those patients who have proven that they can master all
      the activities outlined for Level 3 mobility; that is, they can dangle at the bedside and
      stand and pivot to a chair. Level 4 activities are separated from Level 3 activities only by
      the ability to walk in the hallway.

      Informed consent will occur prior to randomization. Randomization will occur when patients
      have been on the ventilator > 2 days and have mobility scores eligible for walking.
      Randomization will be assigned on a 1:1 ratio to either the RGT or FWW. Patients will be
      randomized using a web-based system called CREDIT.

      Data Analysis A future study will be considered feasible if we are able to enroll 60% of
      eligible patients, have records for 90% of eligible ambulation days, and at least 85% of
      required data fields are completed as designed. Analysis will be based on intention-to-treat;
      that is, regardless of which walker is actually used, the patient will be analyzed in the
      group to which he or she was randomized.

      The primary outcome measure, how many times the patient is mobilized each day, will be
      compared between devices using a hierarchical generalized linear model with number of times
      the patient is mobilized each day as the dependent variable, device, unit and day and an
      interaction of device with day as the independent variables, and subject as the random effect
      in the model. Most likely, ordinal regression will be used with 0, 1, 2 or more times as the
      definition of outcome. If there are too few occurrences of 2 or more, we will convert to a
      logistic model. If one device is better than the other, we would expect the odds of being
      mobilized at a higher level with RGT is significantly different from the odds of being
      mobilized with FWW. We will also test for the interaction of device with time.

      Sources
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Total Number of Times the Critically Ill Ventilator Dependent Patient is Mobilized.
time frame: Duration of Intensive Care Unit Stay (2-30 days)
measure: Length of Time the Critically Ill Ventilator Dependent Patient is Mobilized.
time frame: Patient weight baring to patient seated (1-12 minutes)
arm group label: Front Wheeled Walker
arm group type: Active Comparator
description: The Front Wheeled Walker is a standard walker that is used to assist patients while walking.
arm group label: Rifton Gait Trainer
arm group type: Active Comparator
description: The Rifton Gait Trainer is used to assist patients while walking. It includes a harness to support the patient and prevent falls.
intervention type: Device
intervention name: Rifton Gait Trainer
arm group label: Rifton Gait Trainer
intervention type: Device
intervention name: Front Wheeled Walker
arm group label: Front Wheeled Walker
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MaryAnne Purtill, MD
role: Principal Investigator
affiliation: St. Jospeh Mercy Hospital
facility: 
country: United States
citation: Hopkins RO, Spuhler VJ, Thomsen GE. Transforming ICU culture to facilitate early mobility. Crit Care Clin. 2007 Jan;23(1):81-96. doi: 10.1016/j.ccc.2006.11.004.
PMID: 17307118
citation: Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. doi: 10.1097/01.CCM.0000251130.69568.87.
PMID: 17133183
citation: Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
PMID: 12594312
citation: Needham DM, Korupolu R, Zanni JM, Pradhan P, Colantuoni E, Palmer JB, Brower RG, Fan E. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. doi: 10.1016/j.apmr.2010.01.002.
PMID: 20382284
citation: Fan E, Zanni JM, Dennison CR, Lepre SJ, Needham DM. Critical illness neuromyopathy and muscle weakness in patients in the intensive care unit. AACN Adv Crit Care. 2009 Jul-Sep;20(3):243-53. doi: 10.1097/NCI.0b013e3181ac2551.
PMID: 19638746
citation: Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008 Oct 8;300(14):1685-90. doi: 10.1001/jama.300.14.1685.
PMID: 18840842
citation: Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
PMID: 18596631
citation: Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
PMID: 19446324
citation: Needham DM, Wang W, Desai SV, Mendez-Tellez PA, Dennison CR, Sevransky J, Shanholtz C, Ciesla N, Spillman K, Pronovost PJ. Intensive care unit exposures for long-term outcomes research: development and description of exposures for 150 patients with acute lung injury. J Crit Care. 2007 Dec;22(4):275-84. doi: 10.1016/j.jcrc.2007.02.001. Epub 2007 Jun 27.
PMID: 18086397
responsible party type: Sponsor
mesh term: Mobility Limitation
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 