<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/NCT01668420</url>
  </required_header>
  <id_info>
    <org_study_id>KMUH-IRB-980332</org_study_id>
    <nct_id>NCT01668420</nct_id>
  </id_info>
  <brief_title>Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke</brief_title>
  <official_title>Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hsin-Wen Hsu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The thermal stimulation have been proven effective in upper extremity of stroke patients.&#xD;
      Therefore, this study explored the efficacy of thermal stimulation in lower extremity of&#xD;
      stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are two groups of stroke patients (onset &gt; 3 months) in this study. The independent&#xD;
      factor is temperature of the alternated heat and cold applying.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2009</start_date>
  <completion_date type="Actual">December 2010</completion_date>
  <primary_completion_date type="Actual">December 2010</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change score from baseline to post-treatment and baseline to 1M follow-up in the lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM)</measure>
    <time_frame>pre, post, 1M follow-up</time_frame>
    <description>The lower-limb subscale of the Stroke Rehabilitation Assessment of Movement (LE-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change score from baseline to post-treatment and baseline to 1M follow-up in the mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM)</measure>
    <time_frame>pre, post, 1M follow-up</time_frame>
    <description>The mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC)</measure>
    <time_frame>pre, post, 1M follow-up</time_frame>
    <description>Functional Ambulation Category (FAC) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index</measure>
    <time_frame>pre, post, 1M follow-up</time_frame>
    <description>Barthel Index (BI) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)</measure>
    <time_frame>pre, post, 1M follow-up</time_frame>
    <description>Postural Assessment Scale for Stroke Patients (PASS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale</measure>
    <time_frame>pre, post, 1M follow-up</time_frame>
    <description>Modified Ashworth Scale (MAS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>noxious thermal stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heat-pain:46-47°C and Cold-pain:2-3°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>thermal stimulation (innocuous)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Heat:40-41°C and Cold:23-24°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>thermal stimulation</intervention_name>
    <description>hot and cold/warm and cool pads applying.</description>
    <arm_group_label>noxious thermal stimulation</arm_group_label>
    <arm_group_label>thermal stimulation (innocuous)</arm_group_label>
    <other_name>Thermal stimulation (FIRSTEK, Model-B401L,local company).</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusive criteria:&#xD;
&#xD;
          -  first-ever stroke&#xD;
&#xD;
          -  stroke onset &gt; 3 months and &lt; 3 years before the study enrollment&#xD;
&#xD;
          -  unilateral hemiplegia&#xD;
&#xD;
          -  ability to sit on a chair &gt; 30 minutes independently&#xD;
&#xD;
          -  able to follow verbal instructions&#xD;
&#xD;
          -  age between 18 y/o and 80 y/o&#xD;
&#xD;
          -  be willing to participate in this study and gave their informed consent&#xD;
&#xD;
        The exclusive criteria:&#xD;
&#xD;
          -  skin disease, skin injuries, burns, or fresh scars over the TS application area&#xD;
&#xD;
          -  contraindication of ice or heat application&#xD;
&#xD;
          -  speech disorder or global aphasia&#xD;
&#xD;
          -  musculoskeletal or cardiac disorders that could potentially interfere&#xD;
&#xD;
          -  diabetic history or sensory impairment attributable to neuropathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsin-Wen Hsin, graduated</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaohsiung Medical University Chung-Ho Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>November 7, 2012</last_update_submitted>
  <last_update_submitted_qc>November 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Medical University Chung-Ho Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Hsin-Wen Hsu</investigator_full_name>
    <investigator_title>physical therapist (graduated student)</investigator_title>
  </responsible_party>
  <keyword>thermal stimulation</keyword>
  <keyword>lower extremity</keyword>
  <keyword>temperature</keyword>
  <keyword>efficacy</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/NCT01668420
org study id: KMUH-IRB-980332
nct id: NCT01668420
lead sponsor: 
collaborator: 
has dmc: No
The thermal stimulation have been proven effective in upper extremity of stroke patients.
      Therefore, this study explored the efficacy of thermal stimulation in lower extremity of
      stroke patients.
There are two groups of stroke patients (onset > 3 months) in this study. The independent
      factor is temperature of the alternated heat and cold applying.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM)
time frame: pre, post, 1M follow-up
description: The lower-limb subscale of the Stroke Rehabilitation Assessment of Movement (LE-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM)
time frame: pre, post, 1M follow-up
description: The mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC)
time frame: pre, post, 1M follow-up
description: Functional Ambulation Category (FAC) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index
time frame: pre, post, 1M follow-up
description: Barthel Index (BI) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)
time frame: pre, post, 1M follow-up
description: Postural Assessment Scale for Stroke Patients (PASS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
measure: The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale
time frame: pre, post, 1M follow-up
description: Modified Ashworth Scale (MAS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.
arm group label: noxious thermal stimulation
arm group type: Experimental
description: Heat-pain:46-47°C and Cold-pain:2-3°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given
arm group label: thermal stimulation (innocuous)
arm group type: Active Comparator
description: Heat:40-41°C and Cold:23-24°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given
intervention type: Other
intervention name: thermal stimulation
description: hot and cold/warm and cool pads applying.
arm group label: noxious thermal stimulation
arm group label: thermal stimulation (innocuous)
other name: Thermal stimulation (FIRSTEK, Model-B401L,local company).
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hsin-Wen Hsin, graduated
role: Principal Investigator
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
investigator full name: Hsin-Wen Hsu
investigator title: physical therapist (graduated student)
mesh term: Stroke