<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/NCT03778905</url>
  </required_header>
  <id_info>
    <org_study_id>CMMC10711-J02</org_study_id>
    <nct_id>NCT03778905</nct_id>
  </id_info>
  <brief_title>The Correlation Between the Length of Stay in Post Acute Care(PAC) and General Improvements in Stroke Patients</brief_title>
  <official_title>The Correlation Between the Length of Stay in Post Acute Care(PAC) and General Improvements in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chimei Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chimei Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-Acute Care(PAC) had been inaugurated in Taiwan for almost four years and current essays&#xD;
      revealed positive effects upon general improvements in stroke patient after PAC training.&#xD;
      During acute phase, a stroke patient would admit to internal medicine or surgical ward and&#xD;
      transferred to rehabilitative ward for more intensive therapeutic programs, restoring muscle&#xD;
      power and promoting activity of daily life(ADL) ability. Under relative stable condition, the&#xD;
      patient would transfer to PAC institution or hospitals afterwards for continuing&#xD;
      rehabilitative program if the patient is acknowledged to have rehabilitative potentials.&#xD;
      However, there's still lacking of investigation upon whether the length of stay in PAC&#xD;
      correlates to general improvements. Thus, stroke patients' functional ability, such as&#xD;
      activities of daily living (ADL) function, swallowing ability and so on, as well as their&#xD;
      corresponding scales were assessed on the first and last day during PAC hospitalization.&#xD;
      Statistical analysis was conducted via SPSS ver21.0 to compare the relationship of&#xD;
      improvements in functional ability and the length of stay in PAC. We're looking forward to&#xD;
      the final results!&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional ability in stroke patients are evaluated by following measurements. Activity of&#xD;
      daily life (ADL) function was estimated through modified Rankin scale(MRS) and Barthel&#xD;
      index(BI), swallowing ability by functional oral intake scale, nutritional status via mini&#xD;
      nutritional assessment, life quality through EuroQoL-5D, instrumental ADL function by&#xD;
      Lawton-Brody IADL Scale(IADL), balance/coordination via Berg Balance Test, walking speed&#xD;
      through Usual Gait Speed, cardiopulmonary capability by Six-Minute Walk Test, occupational&#xD;
      mobility (amount use/quality) via Motor Activity Log, language through concise Chinese&#xD;
      aphasia test, motor function of upper extremities by Fugl-Meyer Assessment and so on.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">June 22, 2019</completion_date>
  <primary_completion_date type="Actual">December 14, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Activity of daily life function</measure>
    <time_frame>35 days</time_frame>
    <description>Activity of daily life function is evaluated by both Barthel index(Range: 0~100 score; higher score indicates better function) and Modified Rankin Scale(Grade 1~6; the lower grade indicates better function). Task-oriented activity of daily life is assessed by Industrial activity of daily life(Range: Male 0~5 score and female 0~8 score; Higher score indicates better function)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutritional status</measure>
    <time_frame>35 days</time_frame>
    <description>Nutritional status is evaluated by Mini nutritional assessment(Range: 0.0~30.0). Higher score indicates better function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral intake function</measure>
    <time_frame>35 days</time_frame>
    <description>Oral intake is evaluated by Functional oral intake scale(Range: level 1~7). Higher level indicates better function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiopulmonary capacity</measure>
    <time_frame>35 days</time_frame>
    <description>Cardiopulmonary capacity is evaluated by 6-minute walk test, which requires the patients to walk as much as they can within 6 minutes. Walking length is presented in meters. Longer distance and more meters indicate better function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Walking speed</measure>
    <time_frame>35 days</time_frame>
    <description>Walking speed is evaluated by Usual Gait Speed, which require the patients to walk certain distance and record the time that needed to finish the whole course. Time is presented with seconds. The shorter time and lower seconds indicate better function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Upper motor hand function</measure>
    <time_frame>35 days</time_frame>
    <description>Upper motor hand function is evaluated by Fugl-Meyer assessment(Range 0~44 scores) Higher scores indicate better function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Life quality</measure>
    <time_frame>35 days</time_frame>
    <description>Life quality is evaluated by EuroQoL-5D(Range: 5~15 scores). Lower scores indicate better life quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance and coordination</measure>
    <time_frame>35 days</time_frame>
    <description>Balance and coordination is evaluated by Berg-Balance test(Range: 0~56). Higher scores indicate better function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognition</measure>
    <time_frame>35 days</time_frame>
    <description>Cognition is evaluated by Mini-Mental Sate Examination(Range: 0~30 score). Higher scores indicate better cognition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speech function</measure>
    <time_frame>35 days</time_frame>
    <description>Speech function is evaluated by Concise Chinese Aphasia Test(Range: 1~12 scores). Higher scores indicate better speech function</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">305</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>stroke patient with complete post-acute care hospitalization</arm_group_label>
    <description>This study aims on stroke patients with complete rehabilitative program in post acute care institution and we try to assess their functional improvements after rehabilitative training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation</intervention_name>
    <description>The stroke patients who admitted to post acute care(PAC) institution would undergo regular rehabilitation.</description>
    <arm_group_label>stroke patient with complete post-acute care hospitalization</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stroke patient who meet up criteria of &gt;18 y/o, acute onset of stroke within 30 days and&#xD;
        Modified Rankin Scale 2~4 as well as complete post acute care(PAC) rehabilitative program.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 y/o&#xD;
&#xD;
          -  acute onset of stroke within 30 days&#xD;
&#xD;
          -  Modified Rankin Scale 2~4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients refused to join post acute care(PAC) program&#xD;
&#xD;
          -  hemodynamic unstable&#xD;
&#xD;
          -  disease progression&#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>Willy Chou, MD, MS</last_name>
    <role>Study Director</role>
    <affiliation>Chi Mei Medical Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chi Mei Medical Center</name>
      <address>
        <city>Tainan</city>
        <zip>71004</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chi Mei Medical Hospital</investigator_affiliation>
    <investigator_full_name>Willy Chou</investigator_full_name>
    <investigator_title>Director of physical medicine and rehabiliation</investigator_title>
  </responsible_party>
  <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>
    <ipd_description>There is no plan to make individual participant data (IPD) available to other researchers.</ipd_description>
  </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/NCT03778905
org study id: CMMC10711-J02
nct id: NCT03778905
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Post-Acute Care(PAC) had been inaugurated in Taiwan for almost four years and current essays
      revealed positive effects upon general improvements in stroke patient after PAC training.
      During acute phase, a stroke patient would admit to internal medicine or surgical ward and
      transferred to rehabilitative ward for more intensive therapeutic programs, restoring muscle
      power and promoting activity of daily life(ADL) ability. Under relative stable condition, the
      patient would transfer to PAC institution or hospitals afterwards for continuing
      rehabilitative program if the patient is acknowledged to have rehabilitative potentials.
      However, there's still lacking of investigation upon whether the length of stay in PAC
      correlates to general improvements. Thus, stroke patients' functional ability, such as
      activities of daily living (ADL) function, swallowing ability and so on, as well as their
      corresponding scales were assessed on the first and last day during PAC hospitalization.
      Statistical analysis was conducted via SPSS ver21.0 to compare the relationship of
      improvements in functional ability and the length of stay in PAC. We're looking forward to
      the final results!
Functional ability in stroke patients are evaluated by following measurements. Activity of
      daily life (ADL) function was estimated through modified Rankin scale(MRS) and Barthel
      index(BI), swallowing ability by functional oral intake scale, nutritional status via mini
      nutritional assessment, life quality through EuroQoL-5D, instrumental ADL function by
      Lawton-Brody IADL Scale(IADL), balance/coordination via Berg Balance Test, walking speed
      through Usual Gait Speed, cardiopulmonary capability by Six-Minute Walk Test, occupational
      mobility (amount use/quality) via Motor Activity Log, language through concise Chinese
      aphasia test, motor function of upper extremities by Fugl-Meyer Assessment and so on.
observational model: Other
time perspective: Retrospective
measure: Activity of daily life function
time frame: 35 days
description: Activity of daily life function is evaluated by both Barthel index(Range: 0~100 score; higher score indicates better function) and Modified Rankin Scale(Grade 1~6; the lower grade indicates better function). Task-oriented activity of daily life is assessed by Industrial activity of daily life(Range: Male 0~5 score and female 0~8 score; Higher score indicates better function)
measure: Nutritional status
time frame: 35 days
description: Nutritional status is evaluated by Mini nutritional assessment(Range: 0.0~30.0). Higher score indicates better function
measure: Oral intake function
time frame: 35 days
description: Oral intake is evaluated by Functional oral intake scale(Range: level 1~7). Higher level indicates better function.
measure: Cardiopulmonary capacity
time frame: 35 days
description: Cardiopulmonary capacity is evaluated by 6-minute walk test, which requires the patients to walk as much as they can within 6 minutes. Walking length is presented in meters. Longer distance and more meters indicate better function.
measure: Walking speed
time frame: 35 days
description: Walking speed is evaluated by Usual Gait Speed, which require the patients to walk certain distance and record the time that needed to finish the whole course. Time is presented with seconds. The shorter time and lower seconds indicate better function.
measure: Upper motor hand function
time frame: 35 days
description: Upper motor hand function is evaluated by Fugl-Meyer assessment(Range 0~44 scores) Higher scores indicate better function.
measure: Life quality
time frame: 35 days
description: Life quality is evaluated by EuroQoL-5D(Range: 5~15 scores). Lower scores indicate better life quality.
measure: Balance and coordination
time frame: 35 days
description: Balance and coordination is evaluated by Berg-Balance test(Range: 0~56). Higher scores indicate better function.
measure: Cognition
time frame: 35 days
description: Cognition is evaluated by Mini-Mental Sate Examination(Range: 0~30 score). Higher scores indicate better cognition.
measure: Speech function
time frame: 35 days
description: Speech function is evaluated by Concise Chinese Aphasia Test(Range: 1~12 scores). Higher scores indicate better speech function
arm group label: stroke patient with complete post-acute care hospitalization
description: This study aims on stroke patients with complete rehabilitative program in post acute care institution and we try to assess their functional improvements after rehabilitative training.
intervention type: Other
intervention name: Rehabilitation
description: The stroke patients who admitted to post acute care(PAC) institution would undergo regular rehabilitation.
arm group label: stroke patient with complete post-acute care hospitalization
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Willy Chou, MD, MS
role: Study Director
affiliation: Chi Mei Medical Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chi Mei Medical Hospital
investigator full name: Willy Chou
investigator title: Director of physical medicine and rehabiliation
mesh term: Stroke
sharing ipd: No
ipd description: There is no plan to make individual participant data (IPD) available to other researchers.