xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06035484</url>
    </required_header>
    <id_info>
      <org_study_id>HS25835 (H2023:027)</org_study_id>
      <nct_id>NCT06035484</nct_id>
    </id_info>
    <brief_title>Effect of Seat Height and Angle on Wheelchair Foot Propulsion</brief_title>
    <official_title>Effect of Seat Height and Angle on Wheelchair Foot Propulsion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Manitoba</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Manitoba</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 purpose of the project is to explore the effect of differences in seat height and seat&#xD;
        angle on bilateral foot propulsion using a manual wheelchair. The objectives of the study are&#xD;
        to determine whether differences in seat height and seat angle impact: a) propulsion speed;&#xD;
        b) knee range of motion used during propulsion; c) effectiveness of foot propulsion gait; and&#xD;
        d) perceived difficulty with foot propulsion.&#xD;
  &#xD;
        A repeated measures designs allows comparison between 5 different seat height conditions and&#xD;
        4 different seat angle conditions to determine whether there are significant differences in&#xD;
        outcome, and if so, which conditions provide better outcomes. Participants will propel a&#xD;
        customized MWC through a standardized course using each seat configuration; the sequence will&#xD;
        be randomized to reduce any learning effects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 20, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Within-subjects repeated measures design</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Propulsion speed</measure>
      <time_frame>~30-60 seconds</time_frame>
      <description>Speed will be determined via video recording. Two outcomes will be determined initial 10m and total test course</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knee range of motion</measure>
      <time_frame>~30-60 seconds</time_frame>
      <description>Xsens sensors and mobile app will be used to determine the positions of the thigh and lower leg and knee joint angle will be obtained from the difference between these positions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effectiveness of foot propulsion gait</measure>
      <time_frame>~30-60 seconds</time_frame>
      <description>Evaluated using the Wheelchair Propulsion Test developed by Askari et al. (2013). Simple, valid and reliable measure of propulsion for either upper or lower extremity propulsion techniques.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived difficulty with foot propulsion</measure>
      <time_frame>~30-60 seconds</time_frame>
      <description>Participant will provide subjective evaluations of how difficult they found foot propulsion after each trial, using Perceived Difficulty Questionnaire (Heinrichs et al., 2021).</description>
    </primary_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>LL &amp; 0</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wheelchair seat height will be positioned at lower leg length and set inclination will be zero</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LL + 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wheelchair seat height will be positioned at the participant's leg length plus one inch with an inclination of zero</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LL - 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wheelchair seat height will be positioned at the participant's leg length minus one inch with an inclination of zero</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LL - 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wheelchair seat height will be positioned at the participant's leg length minus two inches with an inclination of zero</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LL - 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wheelchair seat height will be positioned at the participant's leg length minus three inches with an inclination of zero</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3 degrees Inclination</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 3 degrees</description>
    </arm_group>
    <arm_group>
      <arm_group_label>6 degrees Inclination</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 6 degrees</description>
    </arm_group>
    <arm_group>
      <arm_group_label>9 degrees Inclination</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 9 degrees</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Seat height</intervention_name>
      <description>Seat height of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.</description>
      <arm_group_label>LL &amp; 0</arm_group_label>
      <arm_group_label>LL + 1</arm_group_label>
      <arm_group_label>LL - 1</arm_group_label>
      <arm_group_label>LL - 2</arm_group_label>
      <arm_group_label>LL - 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Seat inclination</intervention_name>
      <description>Seat inclination of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.</description>
      <arm_group_label>3 degrees Inclination</arm_group_label>
      <arm_group_label>6 degrees Inclination</arm_group_label>
      <arm_group_label>9 degrees Inclination</arm_group_label>
      <arm_group_label>LL &amp; 0</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  student in College of Rehabilitation Sciences enrolled in Master of Occupational&#xD;
               Therapy, Master of Physical Therapy, or Bachelor of Respiratory Therapy program at the&#xD;
               University of Manitoba.&#xD;
  &#xD;
            -  Able-bodied individuals&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Students whose hip width exceeds 21 inches or lower leg length is shorter than 16&#xD;
               inches will be excluded as the test manual wheelchair will not accommodate these&#xD;
               dimensions.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ed Giesbrecht, PhD</last_name>
      <phone>204-977-5630</phone>
      <email>ed.giesbrecht@umanitoba.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kara Harrison, MSc</last_name>
      <phone>204-787-8015</phone>
      <email>harris78@myumanitoba.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Manitoba</name>
        <address>
          <city>Winnipeg</city>
          <state>Manitoba</state>
          <zip>R3E 0T6</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ed Giesbrecht, PhD</last_name>
        <phone>204-977-5630</phone>
        <email>Ed.Giesbrecht@umanitoba.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Askari S, Kirby RL, Parker K, Thompson K, O'Neill J. Wheelchair propulsion test: development and measurement properties of a new test for manual wheelchair users. Arch Phys Med Rehabil. 2013 Sep;94(9):1690-8. doi: 10.1016/j.apmr.2013.03.002. Epub 2013 Mar 14.</citation>
      <PMID>23499781</PMID>
    </reference>
    <reference>
      <citation>Heinrichs ND, Kirby RL, Smith C, Russell KFJ, Theriault CJ, Doucette SP. Effect of seat height on manual wheelchair foot propulsion, a repeated-measures crossover study: part 1 - wheeling forward on a smooth level surface. Disabil Rehabil Assist Technol. 2021 Nov;16(8):831-839. doi: 10.1080/17483107.2020.1741036. Epub 2020 Apr 2.</citation>
      <PMID>32238086</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>February 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Manitoba</investigator_affiliation>
      <investigator_full_name>Ed Giesbrecht</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>Manual Wheelchair</keyword>
    <keyword>Bilateral propulsion</keyword>
    <keyword>Foot propulsion</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will not be shared outside of the principle and student investigator's conducting this study.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06035484
  org study id: HS25835 (H2023:027)
  nct id: NCT06035484
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the project is to explore the effect of differences in seat height and seat
        angle on bilateral foot propulsion using a manual wheelchair. The objectives of the study are
        to determine whether differences in seat height and seat angle impact: a) propulsion speed;
        b) knee range of motion used during propulsion; c) effectiveness of foot propulsion gait; and
        d) perceived difficulty with foot propulsion.
  
        A repeated measures designs allows comparison between 5 different seat height conditions and
        4 different seat angle conditions to determine whether there are significant differences in
        outcome, and if so, which conditions provide better outcomes. Participants will propel a
        customized MWC through a standardized course using each seat configuration; the sequence will
        be randomized to reduce any learning effects.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: Within-subjects repeated measures design
  primary purpose: Other
  masking: None (Open Label)
  measure: Propulsion speed
  time frame: ~30-60 seconds
  description: Speed will be determined via video recording. Two outcomes will be determined initial 10m and total test course
  measure: Knee range of motion
  time frame: ~30-60 seconds
  description: Xsens sensors and mobile app will be used to determine the positions of the thigh and lower leg and knee joint angle will be obtained from the difference between these positions.
  measure: Effectiveness of foot propulsion gait
  time frame: ~30-60 seconds
  description: Evaluated using the Wheelchair Propulsion Test developed by Askari et al. (2013). Simple, valid and reliable measure of propulsion for either upper or lower extremity propulsion techniques.
  measure: Perceived difficulty with foot propulsion
  time frame: ~30-60 seconds
  description: Participant will provide subjective evaluations of how difficult they found foot propulsion after each trial, using Perceived Difficulty Questionnaire (Heinrichs et al., 2021).
  arm group label: LL & 0
  arm group type: Experimental
  description: Wheelchair seat height will be positioned at lower leg length and set inclination will be zero
  arm group label: LL + 1
  arm group type: Experimental
  description: Wheelchair seat height will be positioned at the participant's leg length plus one inch with an inclination of zero
  arm group label: LL - 1
  arm group type: Experimental
  description: Wheelchair seat height will be positioned at the participant's leg length minus one inch with an inclination of zero
  arm group label: LL - 2
  arm group type: Experimental
  description: Wheelchair seat height will be positioned at the participant's leg length minus two inches with an inclination of zero
  arm group label: LL - 3
  arm group type: Experimental
  description: Wheelchair seat height will be positioned at the participant's leg length minus three inches with an inclination of zero
  arm group label: 3 degrees Inclination
  arm group type: Experimental
  description: Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 3 degrees
  arm group label: 6 degrees Inclination
  arm group type: Experimental
  description: Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 6 degrees
  arm group label: 9 degrees Inclination
  arm group type: Experimental
  description: Wheelchair seat height will be positioned at the participant's leg length with a forward seat inclination of 9 degrees
  intervention type: Other
  intervention name: Seat height
  description: Seat height of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
  arm group label: LL & 0
  arm group label: LL + 1
  arm group label: LL - 1
  arm group label: LL - 2
  arm group label: LL - 3
  intervention type: Other
  intervention name: Seat inclination
  description: Seat inclination of a manual wheelchair will be changed according the different arms specified. The participant will complete a course in the manual wheelchair with each arm.
  arm group label: 3 degrees Inclination
  arm group label: 6 degrees Inclination
  arm group label: 9 degrees Inclination
  arm group label: LL & 0
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ed Giesbrecht, PhD
  phone: 204-977-5630
  email: ed.giesbrecht@umanitoba.ca
  last name: Kara Harrison, MSc
  phone: 204-787-8015
  email: harris78@myumanitoba.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  citation: Askari S, Kirby RL, Parker K, Thompson K, O'Neill J. Wheelchair propulsion test: development and measurement properties of a new test for manual wheelchair users. Arch Phys Med Rehabil. 2013 Sep;94(9):1690-8. doi: 10.1016/j.apmr.2013.03.002. Epub 2013 Mar 14.
  PMID: 23499781
  citation: Heinrichs ND, Kirby RL, Smith C, Russell KFJ, Theriault CJ, Doucette SP. Effect of seat height on manual wheelchair foot propulsion, a repeated-measures crossover study: part 1 - wheeling forward on a smooth level surface. Disabil Rehabil Assist Technol. 2021 Nov;16(8):831-839. doi: 10.1080/17483107.2020.1741036. Epub 2020 Apr 2.
  PMID: 32238086
  responsible party type: Principal Investigator
  investigator affiliation: University of Manitoba
  investigator full name: Ed Giesbrecht
  investigator title: Associate professor
  sharing ipd: No
  ipd description: Data will not be shared outside of the principle and student investigator's conducting this study.