<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/NCT02244931</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A00151-40</org_study_id>
    <nct_id>NCT02244931</nct_id>
  </id_info>
  <brief_title>Comparison of Three Different Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury</brief_title>
  <acronym>PAPAW</acronym>
  <official_title>Comparison of Three Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury : Assessment of Biomechanical, Physiological and Functional Properties.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare three assisting devices to propel personal&#xD;
      wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual&#xD;
      wheelchair in patients with spinal cord injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the study is to compare three assisting devices to propel personal&#xD;
      wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual&#xD;
      wheelchair in patients with spinal cord injury.&#xD;
&#xD;
      The study consists of three distinct and independent phases:&#xD;
&#xD;
        -  Phase 1: Performance evaluation on wheelchair ergometer in order to compare the energy&#xD;
           expenditure and kinetic characteristics in comparable situations with regard to speed&#xD;
           and workload imposed to the wheelchair-patient couple.&#xD;
&#xD;
        -  Phase 2: Comparison of maneuverability and ease of crossing usual obstacles in outdoor&#xD;
           and indoor paths with standardised obstacles. Trajectories are to be recorded in order&#xD;
           to allow analysis by independent experts.&#xD;
&#xD;
        -  Phase 3: Comparison of the autonomy of patients afforded by the devices by comparing the&#xD;
           patient's ability to transfer from wheelchair to car seat and from car seat to&#xD;
           wheelchair, as well as ease of wheelchair packing in car, in the context of a standard&#xD;
           city transport involving a car and the wheelchair.&#xD;
&#xD;
      The three phases are to be performed using the standard manual wheelchair and the three&#xD;
      assisting devices in a randomized order.&#xD;
&#xD;
      Three different groups of patients are included in the three phases of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1: physiological parameters : Oxygen consumption.</measure>
    <time_frame>3 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale</measure>
    <time_frame>3 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.</measure>
    <time_frame>3 hours</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Phase 1: Performance evaluation on ergometer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 3 devices are experimented in random order to compare them on performance using an ergometer wheelchair:&#xD;
Servomatic™ assisting device&#xD;
E.Motion© assisting device&#xD;
Standard manual Wheelchair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: Comparison of maneuverability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 3 devices are experimented in random order to compare them on maneuverability:&#xD;
Servomatic™ assisting device&#xD;
E.Motion© assisting device&#xD;
Standard manual Wheelchair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3: Comparison of the autonomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 3 devices are experimented in random order to compare them on the autonomy they afford to patients:&#xD;
Servomatic™ assisting device&#xD;
E.Motion© assisting device&#xD;
Standard manual Wheelchair</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Servomatic™ assisting device</intervention_name>
    <description>Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .</description>
    <arm_group_label>Phase 1: Performance evaluation on ergometer</arm_group_label>
    <arm_group_label>Phase 2: Comparison of maneuverability</arm_group_label>
    <arm_group_label>Phase 3: Comparison of the autonomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>E.Motion© assisting device</intervention_name>
    <description>E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .</description>
    <arm_group_label>Phase 1: Performance evaluation on ergometer</arm_group_label>
    <arm_group_label>Phase 2: Comparison of maneuverability</arm_group_label>
    <arm_group_label>Phase 3: Comparison of the autonomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard manual Wheelchair</intervention_name>
    <description>Standard manual Wheelchair</description>
    <arm_group_label>Phase 1: Performance evaluation on ergometer</arm_group_label>
    <arm_group_label>Phase 2: Comparison of maneuverability</arm_group_label>
    <arm_group_label>Phase 3: Comparison of the autonomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged between 18 and 70 years&#xD;
&#xD;
          -  Spinal cord injury C5-C8, paraplegic D1-D11, and D11 paraplegic below only for phases&#xD;
             1 and 2 phase 1 and 2&#xD;
&#xD;
          -  Spinal cord injury D1 and above only for phase 3&#xD;
&#xD;
          -  Having given free and informed consent&#xD;
&#xD;
          -  Negative pregnancy test for women of childbearing age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No affiliation to a social security scheme&#xD;
&#xD;
          -  Refusal to participate in the clinical trial&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  Major cognitive disorders&#xD;
&#xD;
          -  bedsores&#xD;
&#xD;
          -  Functional abnormality of the shoulder&#xD;
&#xD;
          -  History of cardiovascular disease&#xD;
&#xD;
          -  ECG to suspect coronary insufficiency&#xD;
&#xD;
          -  Pregnant patients without effective treatment or contraceptive&#xD;
&#xD;
          -  Acute complication or systemic organ&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadine NP PELLEGRINI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 92380 Garches, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physical Medicine and Rehabilitation, Raymond Poincaré Hospital</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal cord injuries, paraplegic, manual wheelchairs, assisting propelling device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02244931
org study id: 2011-A00151-40
nct id: NCT02244931
lead sponsor: 
has dmc: No
The purpose of this study is to compare three assisting devices to propel personal
      wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual
      wheelchair in patients with spinal cord injury.
The objective of the study is to compare three assisting devices to propel personal
      wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual
      wheelchair in patients with spinal cord injury.

      The study consists of three distinct and independent phases:

        -  Phase 1: Performance evaluation on wheelchair ergometer in order to compare the energy
           expenditure and kinetic characteristics in comparable situations with regard to speed
           and workload imposed to the wheelchair-patient couple.

        -  Phase 2: Comparison of maneuverability and ease of crossing usual obstacles in outdoor
           and indoor paths with standardised obstacles. Trajectories are to be recorded in order
           to allow analysis by independent experts.

        -  Phase 3: Comparison of the autonomy of patients afforded by the devices by comparing the
           patient's ability to transfer from wheelchair to car seat and from car seat to
           wheelchair, as well as ease of wheelchair packing in car, in the context of a standard
           city transport involving a car and the wheelchair.

      The three phases are to be performed using the standard manual wheelchair and the three
      assisting devices in a randomized order.

      Three different groups of patients are included in the three phases of the study.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Phase 1: physiological parameters : Oxygen consumption.
time frame: 3 hours
measure: Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale
time frame: 3 hours
measure: Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.
time frame: 3 hours
arm group label: Phase 1: Performance evaluation on ergometer
arm group type: Experimental
description: The 3 devices are experimented in random order to compare them on performance using an ergometer wheelchair:
Servomatic™ assisting device
E.Motion© assisting device
Standard manual Wheelchair
arm group label: Phase 2: Comparison of maneuverability
arm group type: Experimental
description: The 3 devices are experimented in random order to compare them on maneuverability:
Servomatic™ assisting device
E.Motion© assisting device
Standard manual Wheelchair
arm group label: Phase 3: Comparison of the autonomy
arm group type: Experimental
description: The 3 devices are experimented in random order to compare them on the autonomy they afford to patients:
Servomatic™ assisting device
E.Motion© assisting device
Standard manual Wheelchair
intervention type: Device
intervention name: Servomatic™ assisting device
description: Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .
arm group label: Phase 1: Performance evaluation on ergometer
arm group label: Phase 2: Comparison of maneuverability
arm group label: Phase 3: Comparison of the autonomy
intervention type: Device
intervention name: E.Motion© assisting device
description: E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .
arm group label: Phase 1: Performance evaluation on ergometer
arm group label: Phase 2: Comparison of maneuverability
arm group label: Phase 3: Comparison of the autonomy
intervention type: Device
intervention name: Standard manual Wheelchair
description: Standard manual Wheelchair
arm group label: Phase 1: Performance evaluation on ergometer
arm group label: Phase 2: Comparison of maneuverability
arm group label: Phase 3: Comparison of the autonomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nadine NP PELLEGRINI, MD
role: Principal Investigator
affiliation: Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 92380 Garches, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries