<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/NCT03781609</url>
  </required_header>
  <id_info>
    <org_study_id>201804133</org_study_id>
    <nct_id>NCT03781609</nct_id>
  </id_info>
  <brief_title>Motor Learning Approach for Manual Wheelchair Users</brief_title>
  <official_title>A Motor Learning Approach to Wheelchair Propulsion Training for Manual Wheelchair Users With SCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Craig H. Neilsen Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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>
      The overall purpose of this project is to pilot test a manual wheelchair (MWC) training&#xD;
      program based on motor learning theory to improve wheelchair propulsion for manual wheelchair&#xD;
      users (MWUs) with spinal cord injury (SCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project objective is to conduct a pilot randomized control trial (RCT) examining (1) the&#xD;
      number of task-specific repetitions required to produce change in wheelchair propulsion&#xD;
      techniques and (2) identifying the most conducive surface (overground or on a stationary&#xD;
      device such as rollers) for implementing a repetition-based manual wheelchair propulsion&#xD;
      training program. The long-term goals of this research are to minimize upper extremity pain&#xD;
      and chronic overuse injury and to increase mobility efficiency in in persons with SCI who use&#xD;
      MWCs for everyday mobility. The current project goal is to test the effects of a&#xD;
      repetition-based manual wheelchair propulsion training program that emphasizes the&#xD;
      recommended clinical practice guidelines (CPG). The expected outcome will be evidence to use&#xD;
      in training MWUs with SCI in proper propulsion techniques in order to prevent or delay pain&#xD;
      and chronic overuse injuries and maximize mobility through efficient wheelchair propulsion&#xD;
      techniques. The long-term impact will be implementing evidence-based MWC propulsion training&#xD;
      in appropriate amounts to facilitate a reduction in pain and dysfunction, a reduction in&#xD;
      health costs, and prolonged participation in major life activities for MWUs with SCI.&#xD;
&#xD;
      Our research aims are to:&#xD;
&#xD;
        1. Compare wheelchair propulsion kinematics, kinetics, and wheelchair performance changes&#xD;
           among three independent groups (Roller Group, Overground Group, Wheelchair Skills&#xD;
           Group).&#xD;
&#xD;
        2. Characterize the dose-response relationship of repetition-based propulsion practice.&#xD;
&#xD;
        3. Evaluate the long-term impact of propulsion training on performance in the lived&#xD;
           environment.&#xD;
&#xD;
      A single-blind pilot RCT will be conducted. Forty-eight individuals with SCI who use MWCs and&#xD;
      who do not follow the recommended clinical guidelines for propulsion will be recruited. Each&#xD;
      participant will be randomized into one of three independent groups: motor learning&#xD;
      repetitions on a roller system (RG), motor learning repetitions overground (OG), or the&#xD;
      placebo-controlled group receiving conventional MWC skills training (WSG). The WSG will&#xD;
      operate as a placebo by receiving basic MWC skills training-the current standard of&#xD;
      rehabilitation care. Participants' kinematics (video motion analysis), kinetics (SmartWheel),&#xD;
      and wheelchair performance overground (Wheelchair Propulsion Test) will be assessed&#xD;
      pre-intervention (Baseline), immediately following intervention (Follow-up), and three&#xD;
      months' post-intervention (3-Month Follow-up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">July 30, 2021</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Video Motion Capture-Hand Axle relationship Change</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>Kinematic data will be collected using a 3D infrared VMC system (VICON, Centennial, CO).106 The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of reflective markers, which will be attached to the participant's third metacarpal and to the wheel axle of the participant's MWC. As the participant propels through the capture volume, the VMC will record the motion of the participant's third metacarpal in relation to the wheelchair axle. Hand-axle relationship will be measured in centimeters and compared across the three testing sessions. This variable corresponds to the recommendations outlined in the CPG (bringing the hand down toward the axle during recovery [hand-axle relationship].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Video Motion Capture-Push Angle Change</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>Kinematic data will be collected using a 3D infrared VMC system (VICON, Centennial, CO).106 The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of reflective markers, which will be attached to the participant's third metacarpal and to the wheel axle of the participant's MWC. As the participant propels through the capture volume, the VMC will record the motion of the participant's third metacarpal in relation to the wheelchair axle. Push angle will be compared across the three testing sessions. This variable corresponds to the recommendations outlined in the CPG (use longer push strokes [push angle].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wheelchair Propulsion Test (WPT)-Number of pushes Change</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. The number of pushes needed to complete the 10 meters,will all noted. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p &lt; .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wheelchair Propulsion Test (WPT)-time to complete 10 meter push Change</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. Observation of the participant's propulsion pattern as well as whether their hands make contact with the pushrims, recovery, time to complete the 10 meters will be collected. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p &lt; .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wheelchair Propulsion Test (WPT)-type of propulsion pattern comparison between time points</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. The participant's dominant propulsion pattern will be noted. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p &lt; .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Outdoor Propulsion Test-Total push count</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Total propulsion counts will be recorded and compared within and between subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outdoor Propulsion Test-# of pushes meeting clinical guidelines</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Propulsion counts will be recorded and compared within and between subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outdoor Propulsion Test-Type of propulsion pattern</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Propulsion patterns will be recorded and compared within and between subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outdoor Propulsion Test-Time to complete route</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Time to complete the route will be recorded and compared within and between subjects.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Wheelchair User's Shoulder Pain Index (WUSPI)</measure>
    <time_frame>Baseline, Up to 4 weeks post intervention and 3-month post intervention</time_frame>
    <description>A self-report measure of shoulder pain in manual wheelchair users (MWUs) during functional activities. The WUSPI consists of a 15-item questionnaire addressing shoulder pain during 15 activities within four domains: transfers, wheelchair mobility, self-care, and general activities. A 10-point visual analog scale ranging from 0 (no pain) to 10 (worst pain) is used to determine pain intensity experienced during each activity. The WUSPI score (from 0 [no pain] to 150 [worst pain] across all items) indicates the participant's level of shoulder pain during functional activities. Reliability and validity have been established by sampling long-term MWUs. The WUSPI has excellent test-retest reliability (ICC = .99),3 excellent internal consistency (α = .97),3 and moderate concurrent validity (r = -.49). Excellent convergent validity was established by correlating the WUSPI with pain intensity on a numeric rating scale (r = .77; p &lt; .003).</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Roller system group (RG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group performing motor learning manual wheelchair propulsion repetitions on a roller system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Overground group (OG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group performing motor learning manual wheelchair propulsion repetitions overground.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - Wheelchair skills group (WSG)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A group receiving conventional manual wheelchair skills training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Roller system group (RG)</intervention_name>
    <description>They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions on the roller system per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion.</description>
    <arm_group_label>Roller system group (RG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Overground group (OG)</intervention_name>
    <description>They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions overground per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion.</description>
    <arm_group_label>Overground group (OG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo - Wheelchair skills group (WSG)</intervention_name>
    <description>They will receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented.</description>
    <arm_group_label>Placebo - Wheelchair skills group (WSG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be 18 to 60 years of age&#xD;
&#xD;
          -  Have a mobility limitation due to SCI, which requires the use of a manual wheelchair&#xD;
             (MWC)&#xD;
&#xD;
          -  Be able to self-propel a MWC bilaterally with their upper extremities&#xD;
&#xD;
          -  Plan to use a MWC for at least 75% of activities throughout the day&#xD;
&#xD;
          -  Live in the community&#xD;
&#xD;
          -  Understand English at a sixth-grade level or higher&#xD;
&#xD;
          -  Be able to follow multi-step instructions&#xD;
&#xD;
          -  Participants must be able to provide informed consent independently&#xD;
&#xD;
          -  Be able to tolerate propelling their wheelchair independently for 10 meters&#xD;
&#xD;
          -  Be willing to participate in three assessments and up to 13 training sessions at the&#xD;
             Enabling Mobility in the Community Laboratory (EMC Lab).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People will be excluded if they maneuver their MWC with their lower extremities or&#xD;
             with only one upper extremity.&#xD;
&#xD;
          -  Individuals who display the proper MWC propulsion techniques during the screening&#xD;
             process, who already follow the CPG, or whose MWC position inhibits them from&#xD;
             following the CPG will be excluded.&#xD;
&#xD;
          -  Potential participants also will be excluded if they have bilateral incoordination due&#xD;
             to strength inequality or neurological involvement that impairs propulsion in a&#xD;
             steady, straight line. Specifically, if a person demonstrates upper extremity strength&#xD;
             inequalities resulting in a 12-inch deviation from a marked pathway, he or she will be&#xD;
             excluded.&#xD;
&#xD;
          -  Other exclusionary criteria include surgeries compromising the integrity of the upper&#xD;
             extremities or cardiovascular complications within the past year.&#xD;
&#xD;
          -  Potential participants will also be excluded if upper extremity or overall bodily pain&#xD;
             is rated 8/10 or higher per the Wong-Baker FACES Numeric Pain Scale (FACES). -In&#xD;
             addition, potential participants will be excluded if they are currently receiving&#xD;
             medical treatment for an acute upper extremity injury, have a Stage IV pressure&#xD;
             injury, or are currently hospitalized.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerri A Morgan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>manual wheelchair</keyword>
  <keyword>wheelchair propulsion</keyword>
  <keyword>occupational therapy</keyword>
  <keyword>motor learning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord 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/NCT03781609
org study id: 201804133
nct id: NCT03781609
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall purpose of this project is to pilot test a manual wheelchair (MWC) training
      program based on motor learning theory to improve wheelchair propulsion for manual wheelchair
      users (MWUs) with spinal cord injury (SCI).
The project objective is to conduct a pilot randomized control trial (RCT) examining (1) the
      number of task-specific repetitions required to produce change in wheelchair propulsion
      techniques and (2) identifying the most conducive surface (overground or on a stationary
      device such as rollers) for implementing a repetition-based manual wheelchair propulsion
      training program. The long-term goals of this research are to minimize upper extremity pain
      and chronic overuse injury and to increase mobility efficiency in in persons with SCI who use
      MWCs for everyday mobility. The current project goal is to test the effects of a
      repetition-based manual wheelchair propulsion training program that emphasizes the
      recommended clinical practice guidelines (CPG). The expected outcome will be evidence to use
      in training MWUs with SCI in proper propulsion techniques in order to prevent or delay pain
      and chronic overuse injuries and maximize mobility through efficient wheelchair propulsion
      techniques. The long-term impact will be implementing evidence-based MWC propulsion training
      in appropriate amounts to facilitate a reduction in pain and dysfunction, a reduction in
      health costs, and prolonged participation in major life activities for MWUs with SCI.

      Our research aims are to:

        1. Compare wheelchair propulsion kinematics, kinetics, and wheelchair performance changes
           among three independent groups (Roller Group, Overground Group, Wheelchair Skills
           Group).

        2. Characterize the dose-response relationship of repetition-based propulsion practice.

        3. Evaluate the long-term impact of propulsion training on performance in the lived
           environment.

      A single-blind pilot RCT will be conducted. Forty-eight individuals with SCI who use MWCs and
      who do not follow the recommended clinical guidelines for propulsion will be recruited. Each
      participant will be randomized into one of three independent groups: motor learning
      repetitions on a roller system (RG), motor learning repetitions overground (OG), or the
      placebo-controlled group receiving conventional MWC skills training (WSG). The WSG will
      operate as a placebo by receiving basic MWC skills training-the current standard of
      rehabilitation care. Participants' kinematics (video motion analysis), kinetics (SmartWheel),
      and wheelchair performance overground (Wheelchair Propulsion Test) will be assessed
      pre-intervention (Baseline), immediately following intervention (Follow-up), and three
      months' post-intervention (3-Month Follow-up).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Video Motion Capture-Hand Axle relationship Change
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: Kinematic data will be collected using a 3D infrared VMC system (VICON, Centennial, CO).106 The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of reflective markers, which will be attached to the participant's third metacarpal and to the wheel axle of the participant's MWC. As the participant propels through the capture volume, the VMC will record the motion of the participant's third metacarpal in relation to the wheelchair axle. Hand-axle relationship will be measured in centimeters and compared across the three testing sessions. This variable corresponds to the recommendations outlined in the CPG (bringing the hand down toward the axle during recovery [hand-axle relationship].
measure: Video Motion Capture-Push Angle Change
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: Kinematic data will be collected using a 3D infrared VMC system (VICON, Centennial, CO).106 The VMC system consists of 14 Vero 2.2 digital cameras to detect the location of reflective markers, which will be attached to the participant's third metacarpal and to the wheel axle of the participant's MWC. As the participant propels through the capture volume, the VMC will record the motion of the participant's third metacarpal in relation to the wheelchair axle. Push angle will be compared across the three testing sessions. This variable corresponds to the recommendations outlined in the CPG (use longer push strokes [push angle].
measure: Wheelchair Propulsion Test (WPT)-Number of pushes Change
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. The number of pushes needed to complete the 10 meters,will all noted. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p < .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.
measure: Wheelchair Propulsion Test (WPT)-time to complete 10 meter push Change
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. Observation of the participant's propulsion pattern as well as whether their hands make contact with the pushrims, recovery, time to complete the 10 meters will be collected. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p < .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.
measure: Wheelchair Propulsion Test (WPT)-type of propulsion pattern comparison between time points
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: The WPT assesses wheelchair mobility and performance of MWUs. The WPT requires MWUs to propel using a self-selected natural velocity across 10 meters of a smooth, flat surface from a static start. The participant's dominant propulsion pattern will be noted. The WPT has excellent test-retest reliability (r = .72-.96), interrater reliability (r = .80-.96), and construct validity (p < .04).14 The data collected from the WPT will assist in identifying changes of propulsion performance pre- and post-intervention and how those changes relate to the Clinical Practice Guidelines for the Preservation of upper Limb function Following Spinal Cord Injury (CPG) recommendation for minimizing the frequency of pushes while retaining the same speed.
measure: Outdoor Propulsion Test-Total push count
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Total propulsion counts will be recorded and compared within and between subjects.
measure: Outdoor Propulsion Test-# of pushes meeting clinical guidelines
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Propulsion counts will be recorded and compared within and between subjects.
measure: Outdoor Propulsion Test-Type of propulsion pattern
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Propulsion patterns will be recorded and compared within and between subjects.
measure: Outdoor Propulsion Test-Time to complete route
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: Participants will be asked to propel their wheelchair in and around the parking lot on a fixed route. This is to assess under different environment the propulsion patterns may differ from the indoor lab environment. Time to complete the route will be recorded and compared within and between subjects.
measure: Wheelchair User's Shoulder Pain Index (WUSPI)
time frame: Baseline, Up to 4 weeks post intervention and 3-month post intervention
description: A self-report measure of shoulder pain in manual wheelchair users (MWUs) during functional activities. The WUSPI consists of a 15-item questionnaire addressing shoulder pain during 15 activities within four domains: transfers, wheelchair mobility, self-care, and general activities. A 10-point visual analog scale ranging from 0 (no pain) to 10 (worst pain) is used to determine pain intensity experienced during each activity. The WUSPI score (from 0 [no pain] to 150 [worst pain] across all items) indicates the participant's level of shoulder pain during functional activities. Reliability and validity have been established by sampling long-term MWUs. The WUSPI has excellent test-retest reliability (ICC = .99),3 excellent internal consistency (α = .97),3 and moderate concurrent validity (r = -.49). Excellent convergent validity was established by correlating the WUSPI with pain intensity on a numeric rating scale (r = .77; p < .003).
arm group label: Roller system group (RG)
arm group type: Active Comparator
description: A group performing motor learning manual wheelchair propulsion repetitions on a roller system.
arm group label: Overground group (OG)
arm group type: Active Comparator
description: A group performing motor learning manual wheelchair propulsion repetitions overground.
arm group label: Placebo - Wheelchair skills group (WSG)
arm group type: Placebo Comparator
description: A group receiving conventional manual wheelchair skills training.
intervention type: Behavioral
intervention name: Roller system group (RG)
description: They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions on the roller system per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion.
arm group label: Roller system group (RG)
intervention type: Behavioral
intervention name: Overground group (OG)
description: They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions overground per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion.
arm group label: Overground group (OG)
intervention type: Behavioral
intervention name: Placebo - Wheelchair skills group (WSG)
description: They will receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented.
arm group label: Placebo - Wheelchair skills group (WSG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Kerri A Morgan, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
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responsible party type: Sponsor
mesh term: Spinal Cord Injuries