<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/NCT02232867</url>
  </required_header>
  <id_info>
    <org_study_id>07-480-04d</org_study_id>
    <nct_id>NCT02232867</nct_id>
  </id_info>
  <brief_title>Arm and Leg Cycling Exercise After Stroke</brief_title>
  <official_title>Adjunct Locomotor Training to Improve Walking Ability After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Victoria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Stroke Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Victoria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been found that arm and leg cycling is similar to walking in terms of the muscle&#xD;
      activation patterns and joint ranges of motion. In addition, arm and leg cycling and walking&#xD;
      activate similar neural pathways. Another advantage of arm and leg cycling is that it&#xD;
      involves coordination of all four limbs in a rhythmic movement. This may be particularly&#xD;
      beneficial given previous findings that arm movement contributes to the activation of leg&#xD;
      muscles during walking in humans. This is achieved with interconnected neural pathways that&#xD;
      link the arms to the legs. These neural interlimb connections remain intact in stroke&#xD;
      victims, such that maximizing the contribution of the arms to the legs may increase&#xD;
      coordination for walking. Thus, the objectives of this research are to determine if arm and&#xD;
      leg cycling can be used to increase the strength of interlimb connections and if this helps&#xD;
      to improve walking ability in a post-stroke population. It is hypothesized that arm and leg&#xD;
      cycling will transfer to improvements in walking in a post stroke population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For those who have suffered a stroke, damage to the brain can result in a decreased ability&#xD;
      to walk, thus decreasing quality of life in a significant way. Traditionally, body weight&#xD;
      supported treadmill training has been used for walking rehabilitation; however, this therapy&#xD;
      requires specialized technicians, equipment, and facilities. Arm and leg cycle ergometers, a&#xD;
      device commonly found in a gym, could provide an inexpensive and readily accessible means for&#xD;
      walking rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Treadmill Walking Characteristics</measure>
    <time_frame>Baseline, immediately post-intervention (average of 4 days following last exercise session)</time_frame>
    <description>Treadmill walking characteristics will be gauged via a customized analysis of muscle activity patterns and lower limb joint kinematics. Walking frequency, symmetry, and timing will also be analyzed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interlimb Connections</measure>
    <time_frame>Baseline, immediately post-intervention (average of 4 days following the last exercise session)</time_frame>
    <description>To assess the strength of inter-limb coupling, simultaneous electrical stimulation will be applied to (5x1.0ms trains at 300Hz) the cutaneous nerves in the hand (superficial radial) and foot (superficial peroneal). The reflex responses recorded in all four limbs will be evaluated at different phases of the walking cycle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>Baseline, immediately post-intervention (average of 4 days following the last exercise session)</time_frame>
    <description>The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brunnstrom recovery stages</measure>
    <time_frame>Baseline, immediately post-intervention (average of 4 days following the last exercise session)</time_frame>
    <description>The Brunnstrom Approach emphasises the synergic pattern of movement which develops during recovery from hemiplegia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go test</measure>
    <time_frame>Baseline, immediately post-intervention (average of 4 days following the last exercise session)</time_frame>
    <description>The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10 meter walk test</measure>
    <time_frame>Baseline, immediately post-intervention (average of 4 days following the last exercise session)</time_frame>
    <description>The 10 meter walk test is a timed test to evaluate walking speed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six minute walk test</measure>
    <time_frame>Baseline, immediately post-intervention (average of 4 days following last exercise session)</time_frame>
    <description>The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Arm and Leg Cycling Exercise Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple baseline test sessions will be used for the same participant to establish a meaningful baseline thus confirming consistency of all outcome measures prior to the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Arm and Leg Cycling Exercise Program</intervention_name>
    <description>Participants will perform arm and leg cycling training three times a week, with 30 minutes of aggregate exercise time per session. To evaluate the physiological cost of exercise, heart rate and a rating of perceived exertion will be collected. The progressive element of this training will include increasing the resistance of the ergometer over the six weeks in order to maintain the same relative exercise stress.</description>
    <arm_group_label>Arm and Leg Cycling Exercise Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stroke&#xD;
&#xD;
          -  lives within the Victoria, Vancouver Island, and Vancouver mainland communities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to stand for 5 minutes unassisted&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>E. Paul Zehr, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Victoria</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Taryn Klarner, M.Sc.</last_name>
    <phone>(250) 472-5487</phone>
    <email>rnl@uvic.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rehabilitation Neuroscience Laboratory</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8W 3N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marj Wilder, B.Sc.</last_name>
      <email>mwilder@uvic.ca</email>
    </contact>
    <investigator>
      <last_name>E Paul Zehr, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Victoria</investigator_affiliation>
    <investigator_full_name>Dr. E. Paul Zehr</investigator_full_name>
    <investigator_title>Dr. E. Paul Zehr</investigator_title>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>stroke</keyword>
  <keyword>walking</keyword>
  <keyword>interlimb connections</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT02232867
org study id: 07-480-04d
nct id: NCT02232867
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
It has been found that arm and leg cycling is similar to walking in terms of the muscle
      activation patterns and joint ranges of motion. In addition, arm and leg cycling and walking
      activate similar neural pathways. Another advantage of arm and leg cycling is that it
      involves coordination of all four limbs in a rhythmic movement. This may be particularly
      beneficial given previous findings that arm movement contributes to the activation of leg
      muscles during walking in humans. This is achieved with interconnected neural pathways that
      link the arms to the legs. These neural interlimb connections remain intact in stroke
      victims, such that maximizing the contribution of the arms to the legs may increase
      coordination for walking. Thus, the objectives of this research are to determine if arm and
      leg cycling can be used to increase the strength of interlimb connections and if this helps
      to improve walking ability in a post-stroke population. It is hypothesized that arm and leg
      cycling will transfer to improvements in walking in a post stroke population.
For those who have suffered a stroke, damage to the brain can result in a decreased ability
      to walk, thus decreasing quality of life in a significant way. Traditionally, body weight
      supported treadmill training has been used for walking rehabilitation; however, this therapy
      requires specialized technicians, equipment, and facilities. Arm and leg cycle ergometers, a
      device commonly found in a gym, could provide an inexpensive and readily accessible means for
      walking rehabilitation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Treadmill Walking Characteristics
time frame: Baseline, immediately post-intervention (average of 4 days following last exercise session)
description: Treadmill walking characteristics will be gauged via a customized analysis of muscle activity patterns and lower limb joint kinematics. Walking frequency, symmetry, and timing will also be analyzed
measure: Interlimb Connections
time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
description: To assess the strength of inter-limb coupling, simultaneous electrical stimulation will be applied to (5x1.0ms trains at 300Hz) the cutaneous nerves in the hand (superficial radial) and foot (superficial peroneal). The reflex responses recorded in all four limbs will be evaluated at different phases of the walking cycle.
measure: Fugl-Meyer Assessment
time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
description: The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
measure: Brunnstrom recovery stages
time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
description: The Brunnstrom Approach emphasises the synergic pattern of movement which develops during recovery from hemiplegia.
measure: Timed up and go test
time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
description: The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
measure: 10 meter walk test
time frame: Baseline, immediately post-intervention (average of 4 days following the last exercise session)
description: The 10 meter walk test is a timed test to evaluate walking speed
measure: Six minute walk test
time frame: Baseline, immediately post-intervention (average of 4 days following last exercise session)
description: The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
arm group label: Arm and Leg Cycling Exercise Program
arm group type: Experimental
description: Multiple baseline test sessions will be used for the same participant to establish a meaningful baseline thus confirming consistency of all outcome measures prior to the intervention.
intervention type: Behavioral
intervention name: Arm and Leg Cycling Exercise Program
description: Participants will perform arm and leg cycling training three times a week, with 30 minutes of aggregate exercise time per session. To evaluate the physiological cost of exercise, heart rate and a rating of perceived exertion will be collected. The progressive element of this training will include increasing the resistance of the ergometer over the six weeks in order to maintain the same relative exercise stress.
arm group label: Arm and Leg Cycling Exercise Program
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: E. Paul Zehr, PhD
role: Principal Investigator
affiliation: University of Victoria
last name: Taryn Klarner, M.Sc.
phone: (250) 472-5487
email: rnl@uvic.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Victoria
investigator full name: Dr. E. Paul Zehr
investigator title: Dr. E. Paul Zehr
mesh term: Stroke