<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/NCT04436536</url>
  </required_header>
  <id_info>
    <org_study_id>A-BR-107-101-T</org_study_id>
    <nct_id>NCT04436536</nct_id>
  </id_info>
  <brief_title>Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation</brief_title>
  <official_title>Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng Kung University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tainan Hospital, Ministry of Health and Welfare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cheng Kung University</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>
      This study investigated the effect of treadmill walking training with and without random&#xD;
      speed changes in persons in the chronic stage of stroke. It was hypothesized that random&#xD;
      speed change group will show less attention and balance demands for speed change in level&#xD;
      walking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study includes chronic stroke patients who will be randomly assigned to blocked or&#xD;
      random walking speed change group to receive 30 min per session, 3 sessions per week for 2&#xD;
      weeks' walking training on a treadmill. The outcome measures include gait characteristics&#xD;
      under 3 tasks x 3 speed conditions x 2 attention conditions on an obstacle-free walk way. The&#xD;
      three tasks are normal walking, narrow based walking and obstacle crossing. The three speed&#xD;
      conditions are constant (preferred) speed, speeding up (preferred to maximum speed), and&#xD;
      slowing down (maximum to preferred speed). The two attention conditions are none and serial&#xD;
      subtraction of 3 during walking. Clinical sensorimotor function assessment, including hand&#xD;
      grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and&#xD;
      Fugl-Meyer lower extremity motor scale will be conducted for subject characterization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 26, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>stride characteristics</measure>
    <time_frame>2 weeks</time_frame>
    <description>Wearable movement sensors are used to measure stride characteristics, such step length, gait velocity, under different walking conditions (normal, narrow based, dual task)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>training with random speed changes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Walking training on treadmill with random speed changes, that is, random sequence of several different walking speeds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>training with blocked speed changes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Walking training on treadmill with blocked speed changes, that is a steady progression of faster walking speed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill walking training with random speed changes</intervention_name>
    <description>Participants were asked to walk in different gait speed randomly on the treadmill (80%, 90%, 100%, 110% and 120% of preferred speed). The training speed would be changed in every 15 seconds in 2-minutes-section. 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.</description>
    <arm_group_label>training with random speed changes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill walking training with blocked speed changes</intervention_name>
    <description>Participants were asked to walk in same gait speed on the treadmill per day (80%, 90%, 100%, 110% and 120% of preferred speed, respectively). 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.</description>
    <arm_group_label>training with blocked speed changes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with first stroke for at least 6 months&#xD;
&#xD;
          -  Able to walk for at least 20 minutes independently without exhaustion&#xD;
&#xD;
          -  Residual gait deficits&#xD;
&#xD;
          -  Resting blood pressure is lower than 150/90 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to follow experimental instructions during the process&#xD;
&#xD;
          -  Any pain, inflammation, or other neuromuscular or musculoskeletal conditions in the&#xD;
             lower limbs that affect walking ability&#xD;
&#xD;
          -  Unstable health problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lin Sang-I, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>National Cheng Kung University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lin Sang-I, PhD</last_name>
    <phone>+886-6-235-3535</phone>
    <phone_ext>5020</phone_ext>
    <email>lin31@mail.ncku.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lee Pei-Yun, PhD</last_name>
    <phone>+886-6-235-3535</phone>
    <phone_ext>5936</phone_ext>
    <email>peiyunlee@mail.ncku.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Cheng Kung University</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lin Sang-I, PhD</last_name>
      <phone>+886-6-235-3535</phone>
      <phone_ext>5020</phone_ext>
      <email>lin31@mail.ncku.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng Kung University</investigator_affiliation>
    <investigator_full_name>Sang-I Lin</investigator_full_name>
    <investigator_title>Professor, Department of Physical Therapy, National Cheng Kung University</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>gait</keyword>
  <keyword>dual tasks</keyword>
  <keyword>motor learning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
  </intervention_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/NCT04436536
org study id: A-BR-107-101-T
nct id: NCT04436536
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigated the effect of treadmill walking training with and without random
      speed changes in persons in the chronic stage of stroke. It was hypothesized that random
      speed change group will show less attention and balance demands for speed change in level
      walking.
This study includes chronic stroke patients who will be randomly assigned to blocked or
      random walking speed change group to receive 30 min per session, 3 sessions per week for 2
      weeks' walking training on a treadmill. The outcome measures include gait characteristics
      under 3 tasks x 3 speed conditions x 2 attention conditions on an obstacle-free walk way. The
      three tasks are normal walking, narrow based walking and obstacle crossing. The three speed
      conditions are constant (preferred) speed, speeding up (preferred to maximum speed), and
      slowing down (maximum to preferred speed). The two attention conditions are none and serial
      subtraction of 3 during walking. Clinical sensorimotor function assessment, including hand
      grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and
      Fugl-Meyer lower extremity motor scale will be conducted for subject characterization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: stride characteristics
time frame: 2 weeks
description: Wearable movement sensors are used to measure stride characteristics, such step length, gait velocity, under different walking conditions (normal, narrow based, dual task)
arm group label: training with random speed changes
arm group type: Experimental
description: Walking training on treadmill with random speed changes, that is, random sequence of several different walking speeds
arm group label: training with blocked speed changes
arm group type: Active Comparator
description: Walking training on treadmill with blocked speed changes, that is a steady progression of faster walking speed.
intervention type: Other
intervention name: Treadmill walking training with random speed changes
description: Participants were asked to walk in different gait speed randomly on the treadmill (80%, 90%, 100%, 110% and 120% of preferred speed). The training speed would be changed in every 15 seconds in 2-minutes-section. 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.
arm group label: training with random speed changes
intervention type: Other
intervention name: Treadmill walking training with blocked speed changes
description: Participants were asked to walk in same gait speed on the treadmill per day (80%, 90%, 100%, 110% and 120% of preferred speed, respectively). 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.
arm group label: training with blocked speed changes
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lin Sang-I, PhD
role: Study Chair
affiliation: National Cheng Kung University
last name: Lin Sang-I, PhD
phone: +886-6-235-3535
phone ext: 5020
email: lin31@mail.ncku.edu.tw
last name: Lee Pei-Yun, PhD
phone: +886-6-235-3535
phone ext: 5936
email: peiyunlee@mail.ncku.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng Kung University
investigator full name: Sang-I Lin
investigator title: Professor, Department of Physical Therapy, National Cheng Kung University
mesh term: Stroke
mesh term: Methamphetamine