<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/NCT03264261</url>
  </required_header>
  <id_info>
    <org_study_id>R01HD082216</org_study_id>
    <nct_id>NCT03264261</nct_id>
  </id_info>
  <brief_title>Constraint Induced Movement Therapy for Walking in Individuals Post Stroke</brief_title>
  <official_title>Constraint Induced Movement Therapy for Walking in Individuals Post Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shirley Ryan AbilityLab</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training&#xD;
      only on walking function in individuals post-stroke, a 6 week, single-blind, randomized&#xD;
      training study will be conducted with three assessments of gait to determine the training&#xD;
      effect. Subjects will be randomized to either the CIMT or treadmill training only groups at&#xD;
      the initial test. Following the initial test, individuals from the 2 groups will undergo&#xD;
      intensive locomotor training. Training will be performed 3 times per week for 6 weeks with&#xD;
      the training time for each visit set to 45 minutes as tolerated. Data collection will proceed&#xD;
      until 36 subjects from 2 groups have been trained.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine the effect of constraint induced movement therapy (CIMT) on locomotor function&#xD;
      in individuals post stroke. In order to compare the effect of CIMT vs. treadmill training&#xD;
      only on walking function in individuals post-stroke, a 6 week, single-blind, randomized&#xD;
      training study will be conducted with three assessments of gait to determine the training&#xD;
      effect. Subjects will be blocked by gait speed into slow (&lt; 0.4 m/s) or fast (≥ 0.4 m/s)&#xD;
      subgroups and randomized to either the CIMT or treadmill training only groups at the initial&#xD;
      test. Following the initial test, individuals from the 2 groups will undergo intensive&#xD;
      locomotor training. Training will be performed 3 times per week for 6 weeks with the training&#xD;
      time for each visit set to 45 minutes as tolerated, excluding set up time. Data collection&#xD;
      will proceed until 36 subjects from 2 groups have been trained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will be blocked by gait speed into slow (&lt; 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome measures of each subject will be evaluated before training, after 6 weeks of training, and at 8 weeks after the end of training by a physical therapist who is blinded by subject group assignment, and subjects will be requested not to disclose his/her group assignment to this physical therapist.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in walking speed</measure>
    <time_frame>pre, post 6 weeks training, and 8 weeks after the end of training.</time_frame>
    <description>Overground gait speed will be collected on a 10 m instrumented walkway</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in 6-minute walking distance</measure>
    <time_frame>pre, post 6 weeks training, and 8 weeks after the end of training.</time_frame>
    <description>walking distance covered by subjects in 6 minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Berg Balance Scale</measure>
    <time_frame>pre, post 6 weeks training, and 8 weeks after the end of training.</time_frame>
    <description>Berg Balance Scale scores will be collected by research physical therapist</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>robotic training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the robotic training group, a controlled resistance load will be applied to the unaffected leg at the ankle and an assistance load will be applied to the pelvis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treadmill training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the treadmill training only group, a physical therapist will provide manual assistance to the affected leg at the knee and/or ankle joints as necessary during treadmill training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>robotic training</intervention_name>
    <description>robotic training, 3 times/week for 6 weeks</description>
    <arm_group_label>robotic training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>treadmill training</intervention_name>
    <description>treadmill training only, 3 times/week for 6 weeks</description>
    <arm_group_label>treadmill training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age between 21 and 75 years;&#xD;
&#xD;
          2. history of unilateral, supratentorial, ischemic or hemorrhagic stroke;&#xD;
&#xD;
          3. no prior stroke;&#xD;
&#xD;
          4. demonstration of impaired walking function (self-selected walking speed ≤ 0.80 m/s);&#xD;
&#xD;
          5. able to stand and walk (&gt;10 meters) without physical assistance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. significant cardiorespiratory/metabolic disease;&#xD;
&#xD;
          2. other neurological or orthopedic injury that impairs locomotion;&#xD;
&#xD;
          3. scores on the Mini Mental Status examination &lt; 24;&#xD;
&#xD;
          4. stroke of the brainstem or cerebellar lesions;&#xD;
&#xD;
          5. uncontrolled hypertension (systolic &gt; 200 mm Hg, diastolic &gt; 110 mm Hg);&#xD;
&#xD;
          6. botox injection within 6 months of starting the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Wu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abilitylab</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weena Dee, PT</last_name>
    <phone>312-238-7503</phone>
    <email>wdee@ric.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Abilitylab</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weena Dee, PT</last_name>
      <phone>312-238-7503</phone>
      <email>wdee@sralab.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Ming Wu</investigator_full_name>
    <investigator_title>Research Scientist</investigator_title>
  </responsible_party>
  <keyword>stroke, locomotion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03264261
org study id: R01HD082216
nct id: NCT03264261
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training
      only on walking function in individuals post-stroke, a 6 week, single-blind, randomized
      training study will be conducted with three assessments of gait to determine the training
      effect. Subjects will be randomized to either the CIMT or treadmill training only groups at
      the initial test. Following the initial test, individuals from the 2 groups will undergo
      intensive locomotor training. Training will be performed 3 times per week for 6 weeks with
      the training time for each visit set to 45 minutes as tolerated. Data collection will proceed
      until 36 subjects from 2 groups have been trained.
To determine the effect of constraint induced movement therapy (CIMT) on locomotor function
      in individuals post stroke. In order to compare the effect of CIMT vs. treadmill training
      only on walking function in individuals post-stroke, a 6 week, single-blind, randomized
      training study will be conducted with three assessments of gait to determine the training
      effect. Subjects will be blocked by gait speed into slow (< 0.4 m/s) or fast (≥ 0.4 m/s)
      subgroups and randomized to either the CIMT or treadmill training only groups at the initial
      test. Following the initial test, individuals from the 2 groups will undergo intensive
      locomotor training. Training will be performed 3 times per week for 6 weeks with the training
      time for each visit set to 45 minutes as tolerated, excluding set up time. Data collection
      will proceed until 36 subjects from 2 groups have been trained.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be blocked by gait speed into slow (< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome measures of each subject will be evaluated before training, after 6 weeks of training, and at 8 weeks after the end of training by a physical therapist who is blinded by subject group assignment, and subjects will be requested not to disclose his/her group assignment to this physical therapist.
measure: Change in walking speed
time frame: pre, post 6 weeks training, and 8 weeks after the end of training.
description: Overground gait speed will be collected on a 10 m instrumented walkway
measure: Change in 6-minute walking distance
time frame: pre, post 6 weeks training, and 8 weeks after the end of training.
description: walking distance covered by subjects in 6 minutes
measure: Change in Berg Balance Scale
time frame: pre, post 6 weeks training, and 8 weeks after the end of training.
description: Berg Balance Scale scores will be collected by research physical therapist
arm group label: robotic training
arm group type: Experimental
description: For the robotic training group, a controlled resistance load will be applied to the unaffected leg at the ankle and an assistance load will be applied to the pelvis.
arm group label: treadmill training
arm group type: Active Comparator
description: For the treadmill training only group, a physical therapist will provide manual assistance to the affected leg at the knee and/or ankle joints as necessary during treadmill training.
intervention type: Device
intervention name: robotic training
description: robotic training, 3 times/week for 6 weeks
arm group label: robotic training
intervention type: Device
intervention name: treadmill training
description: treadmill training only, 3 times/week for 6 weeks
arm group label: treadmill training
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Wu, PhD
role: Principal Investigator
affiliation: Abilitylab
last name: Weena Dee, PT
phone: 312-238-7503
email: wdee@ric.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Ming Wu
investigator title: Research Scientist
mesh term: Stroke
sharing ipd: No