<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/NCT03268798</url>
  </required_header>
  <id_info>
    <org_study_id>D015017-2011-2015</org_study_id>
    <nct_id>NCT03268798</nct_id>
  </id_info>
  <brief_title>Unilateral Wrist Extension Training After Stroke</brief_title>
  <official_title>Unilateral Wrist Extension Training After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Victoria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of British Columbia</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>
      Following stroke, muscle weakness and impaired motor function are expressed in both the more&#xD;
      (MA; paretic) and less affected (LA; non-paretic) sides. Although the efficacy of resistance&#xD;
      training is well recognized, training the MA limb directly may be initially difficult due to&#xD;
      muscular weakness. &quot;Cross-education&quot; is training one side of the body increases strength in&#xD;
      the untrained and opposite side. This concept can be applied in strength training when&#xD;
      training the more affected sides cannot be initiated. Recently, our lab found six weeks of&#xD;
      dorsiflexion resistance training in the LA leg improved the strength of both trained and&#xD;
      untrained legs of chronic stroke participants.&#xD;
&#xD;
      The current project explored if cross-education exists in the upper limb in chronic stroke&#xD;
      participants and if there are related changes in cortical and spinal cord plasticity. We&#xD;
      hypothesized that unilateral strength in the less affected arm could enhance wrist extension&#xD;
      strength bilaterally with related neural adoption and improved clinical function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke produces muscle weakness seen on both more (paretic, MA) and less affected&#xD;
      (non-paretic, LA) sides. &quot;Cross-education&quot; is training one side of the body increases&#xD;
      strength or motor skill in the same muscles on the untrained side. This can be applied to&#xD;
      enhance muscle strength in the MA side and we found that 6 weeks of dorsiflexion resistance&#xD;
      training with the LA leg improved strength bilaterally in chronic stroke. To explore if&#xD;
      cross-education occurs also in the upper limb after stroke, participants will complete a&#xD;
      5-week unilateral wrist extension training.&#xD;
&#xD;
      Twenty four participants will be recruited, 12 from Rehabilitation Neuroscience laboratory at&#xD;
      University of Victoria, 12 from Brain Behaviour Laboratory at University of British Columbia.&#xD;
      Before and after training, maximal voluntary contraction wrist extension force was measured&#xD;
      with a 6-axis load cell using Cartesian coordinates (Fz = extension). Electromyography of&#xD;
      extensor and flexor carpi radialis, biceps and triceps brachii were recorded. Fugl-Meyer and&#xD;
      partial Wolf Motor Function Test were performed by the same physical therapist at each&#xD;
      location. Reciprocal inhibition from wrist flexors to extensors, cutaneous reflexes evoked by&#xD;
      median and superficial radial nerve stimulation were assessed in those at UVIC. Cortical&#xD;
      silent period, short-interval intracortical inhibition, intracortical facilitation and&#xD;
      transcallosal inhibition from transcranial magnetic stimulation were measured in participants&#xD;
      at UBC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</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>Changes in wrist extension force</measure>
    <time_frame>Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test; Week 13: follow-up test</time_frame>
    <description>To test if training could improve wrist extension strength, maximal wrist extension force were measured in both arms during the 3 baseline pretests, 1 post-test. There was a week in between each baseline tests, post-test will be performed within one week after the training finished. To test if the force changes maintained after training, follow-up test was performed 5 weeks after training finished.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the modulation of spinal-mediated muscle reflexes</measure>
    <time_frame>Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;</time_frame>
    <description>To test if training could induce neural adaptation at spinal level, spinal-mediated muscle reflexes include reciprocal inhibition and cutaneous reflexes in the wrist extensor muscle were measured. Muscle reflex amplitudes were compared before and after training. There was no follow-up test for this measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neural adaptation in the corticospinal pathway</measure>
    <time_frame>Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;</time_frame>
    <description>To test if training could induced neural adaptation at corticospinal level, cortical silent period, short-interval intracortical inhibition, intracortical facilitation and transcallosal from transcranial magnetic stimulation were measured in wrist extensor muscle. Changes in the muscle reflex amplitudes and cortical silent period duration were compared before and after training. There was no follow-up test for this measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper limb impairment assessments</measure>
    <time_frame>Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;</time_frame>
    <description>Fugl-Meyer test score were assessed by licensed physiotherapists. Scores were compared before and after training. There was no follow-up test for this measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper limb function assessments</measure>
    <time_frame>Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test; Week 13: follow-up test</time_frame>
    <description>Wolf Motor Function Test were assessed by licensed physiotherapists. Scores were compared before and after training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ten-meter walking test</measure>
    <time_frame>Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test;</time_frame>
    <description>Walking speed was compared before and after training. There was no follow-up test for this measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-minute walking test</measure>
    <time_frame>Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;</time_frame>
    <description>Walking distance was compared before and after training. There was no follow-up test for this measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed up and go</measure>
    <time_frame>Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;</time_frame>
    <description>Walking speed was compared before and after training. There was no follow-up test for this measurement.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Wrist extension training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Unilateral wrist extension training</intervention_name>
    <description>Participants will join a five-week training protocol with 3 sessions per week. During each session, 5 sets 5 maximal wrist extension training will be performed on participants less affected side.</description>
    <arm_group_label>Wrist extension training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 6 months post-stroke;&#xD;
&#xD;
          -  One side of arm shows muscle weakness&#xD;
&#xD;
          -  Pass the screening test of Physical Activity Readiness Questionnaire&#xD;
&#xD;
          -  Pass the screening test for dementia&#xD;
&#xD;
          -  Free from dementia (score &lt; 24 on the Montreal Cognitive Assessment) and any other&#xD;
             contradiction for TMS test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had medication affecting muscle tone within the past 3 months&#xD;
&#xD;
          -  Wear a pacemaker&#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</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitation Neuroscience Laboratory, University of Victoria</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</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>Professor</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>strength training</keyword>
  <keyword>rehabilitation</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/NCT03268798
org study id: D015017-2011-2015
nct id: NCT03268798
lead sponsor: 
collaborator: 
has dmc: No
Following stroke, muscle weakness and impaired motor function are expressed in both the more
      (MA; paretic) and less affected (LA; non-paretic) sides. Although the efficacy of resistance
      training is well recognized, training the MA limb directly may be initially difficult due to
      muscular weakness. "Cross-education" is training one side of the body increases strength in
      the untrained and opposite side. This concept can be applied in strength training when
      training the more affected sides cannot be initiated. Recently, our lab found six weeks of
      dorsiflexion resistance training in the LA leg improved the strength of both trained and
      untrained legs of chronic stroke participants.

      The current project explored if cross-education exists in the upper limb in chronic stroke
      participants and if there are related changes in cortical and spinal cord plasticity. We
      hypothesized that unilateral strength in the less affected arm could enhance wrist extension
      strength bilaterally with related neural adoption and improved clinical function.
Stroke produces muscle weakness seen on both more (paretic, MA) and less affected
      (non-paretic, LA) sides. "Cross-education" is training one side of the body increases
      strength or motor skill in the same muscles on the untrained side. This can be applied to
      enhance muscle strength in the MA side and we found that 6 weeks of dorsiflexion resistance
      training with the LA leg improved strength bilaterally in chronic stroke. To explore if
      cross-education occurs also in the upper limb after stroke, participants will complete a
      5-week unilateral wrist extension training.

      Twenty four participants will be recruited, 12 from Rehabilitation Neuroscience laboratory at
      University of Victoria, 12 from Brain Behaviour Laboratory at University of British Columbia.
      Before and after training, maximal voluntary contraction wrist extension force was measured
      with a 6-axis load cell using Cartesian coordinates (Fz = extension). Electromyography of
      extensor and flexor carpi radialis, biceps and triceps brachii were recorded. Fugl-Meyer and
      partial Wolf Motor Function Test were performed by the same physical therapist at each
      location. Reciprocal inhibition from wrist flexors to extensors, cutaneous reflexes evoked by
      median and superficial radial nerve stimulation were assessed in those at UVIC. Cortical
      silent period, short-interval intracortical inhibition, intracortical facilitation and
      transcallosal inhibition from transcranial magnetic stimulation were measured in participants
      at UBC.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in wrist extension force
time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test; Week 13: follow-up test
description: To test if training could improve wrist extension strength, maximal wrist extension force were measured in both arms during the 3 baseline pretests, 1 post-test. There was a week in between each baseline tests, post-test will be performed within one week after the training finished. To test if the force changes maintained after training, follow-up test was performed 5 weeks after training finished.
measure: Changes in the modulation of spinal-mediated muscle reflexes
time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
description: To test if training could induce neural adaptation at spinal level, spinal-mediated muscle reflexes include reciprocal inhibition and cutaneous reflexes in the wrist extensor muscle were measured. Muscle reflex amplitudes were compared before and after training. There was no follow-up test for this measurement
measure: Neural adaptation in the corticospinal pathway
time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
description: To test if training could induced neural adaptation at corticospinal level, cortical silent period, short-interval intracortical inhibition, intracortical facilitation and transcallosal from transcranial magnetic stimulation were measured in wrist extensor muscle. Changes in the muscle reflex amplitudes and cortical silent period duration were compared before and after training. There was no follow-up test for this measurement.
measure: Upper limb impairment assessments
time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
description: Fugl-Meyer test score were assessed by licensed physiotherapists. Scores were compared before and after training. There was no follow-up test for this measurement.
measure: Upper limb function assessments
time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test; Week 13: follow-up test
description: Wolf Motor Function Test were assessed by licensed physiotherapists. Scores were compared before and after training.
measure: Ten-meter walking test
time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training (no measurement was taken); Week 9: post-test;
description: Walking speed was compared before and after training. There was no follow-up test for this measurement
measure: Six-minute walking test
time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
description: Walking distance was compared before and after training. There was no follow-up test for this measurement
measure: Timed up and go
time frame: Week1-3: baselines were measured once per week for three times; Week 4-8: training(no measurement was taken); Week 9: post-test;
description: Walking speed was compared before and after training. There was no follow-up test for this measurement.
arm group label: Wrist extension training
arm group type: Experimental
intervention type: Device
intervention name: Unilateral wrist extension training
description: Participants will join a five-week training protocol with 3 sessions per week. During each session, 5 sets 5 maximal wrist extension training will be performed on participants less affected side.
arm group label: Wrist extension training
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: E.Paul Zehr
role: Principal Investigator
affiliation: Rehabilitation Neuroscience Laboratory, University of Victoria
responsible party type: Principal Investigator
investigator affiliation: University of Victoria
investigator full name: Dr. E. Paul Zehr
investigator title: Professor
mesh term: Stroke