<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/NCT03279848</url>
  </required_header>
  <id_info>
    <org_study_id>2016.283</org_study_id>
    <nct_id>NCT03279848</nct_id>
  </id_info>
  <brief_title>Stratification of Stroke Rehabilitation: 5-year Profiles of Functional Outcomes</brief_title>
  <official_title>Stratification of Stroke Rehabilitation: 5-year Profiles of Functional Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tai Po Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tai Po Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a&#xD;
      stratification tool to reveal profiles of functional outcomes of patients with stroke in&#xD;
      inpatient rehabilitation.&#xD;
&#xD;
      Design: This was a retrospective, descriptive study of the demographic, functional outcomes&#xD;
      of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients&#xD;
      completed a stroke rehabilitation program from 2011 to 2015 were recruited.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a&#xD;
      stratification tool to reveal profiles of functional outcomes of patients with stroke in&#xD;
      inpatient rehabilitation.&#xD;
&#xD;
      Design: This was a retrospective, descriptive study of the demographic, functional outcomes&#xD;
      of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients&#xD;
      completed a stroke rehabilitation program from 2011 to 2015 were recruited. The patients were&#xD;
      divided into seven groups according to their admission Modified Functional Ambulation&#xD;
      Category (MFAC). The between-group difference in length of stay (LOS), functional outcomes at&#xD;
      admission and discharge including Modified Rivermead Mobility Index (MRMI) and Modified&#xD;
      Barthel Index (MBI) as well as MRMI gain, MRMI efficiency, MBI gain and MBI efficiency were&#xD;
      analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">June 1, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>4 Weeks</target_duration>
  <primary_outcome>
    <measure>Change in Modified Rivermead Mobility Index (MRMI)</measure>
    <time_frame>baseline and 1 month</time_frame>
    <description>MRMI was used to assess subjects' mobility in this study. The MRMI is highly reliable between raters (ICC= 0.98) and has high internal consistency (Cronbach's alpha = 0.93) to early stage patients with stroke. The MRMI consists of eight test items, including turning over, changing from lying to sitting, maintaining sitting balance, going from sitting to standing, standing, transferring, walking indoors, and climbing stairs. The score of MRMI range from 0 to 40. One main characteristic of the MRMI is that participants are scored by observation of their performance on the items directly. Change in MRMI i.e. MRMI gain is the difference between pre-discharge MRMI and admission MRMI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Modified Barthel Index (MBI) Gain</measure>
    <time_frame>baseline and 1 month</time_frame>
    <description>MBI was used to assess subjects' basic activities of daily living (ADL) in this study. MBI measures the subject's performance on ten functional items including self-care, continence, and locomotion. The values assigned to each item are based on the amount of physical assistance required to perform the task and added to give a total score ranging from 0 to 100 (0 = fully dependent, 100 = fully independent) with higher score indicating higher levels of physical function. There are no subtotal score because there are no sub-scales. The internal consistency reliability coefficient for MBI is 0.90. Change in MBI i.e. MBI gain is the difference between pre- discharge MBI and admission MBI.</description>
  </secondary_outcome>
  <enrollment type="Actual">2722</enrollment>
  <condition>Stroke Rehabilitation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia&#xD;
             and has received and completed stroke rehabilitation program in a hospital in Hong&#xD;
             Kong between the periods of 1st January 2011 to 31st December 2015.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia&#xD;
             and has received but cannot completed stroke rehabilitation program in a hospital in&#xD;
             Hong Kong between the periods of 1st January 2011 to 31st December 2015.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 10, 2017</last_update_submitted>
  <last_update_submitted_qc>September 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tai Po Hospital</investigator_affiliation>
    <investigator_full_name>Bryan Ping Ho CHUNG</investigator_full_name>
    <investigator_title>Principal Investigator of Physiotherapy Department</investigator_title>
  </responsible_party>
  <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/NCT03279848
org study id: 2016.283
nct id: NCT03279848
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a
      stratification tool to reveal profiles of functional outcomes of patients with stroke in
      inpatient rehabilitation.

      Design: This was a retrospective, descriptive study of the demographic, functional outcomes
      of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients
      completed a stroke rehabilitation program from 2011 to 2015 were recruited.
Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a
      stratification tool to reveal profiles of functional outcomes of patients with stroke in
      inpatient rehabilitation.

      Design: This was a retrospective, descriptive study of the demographic, functional outcomes
      of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients
      completed a stroke rehabilitation program from 2011 to 2015 were recruited. The patients were
      divided into seven groups according to their admission Modified Functional Ambulation
      Category (MFAC). The between-group difference in length of stay (LOS), functional outcomes at
      admission and discharge including Modified Rivermead Mobility Index (MRMI) and Modified
      Barthel Index (MBI) as well as MRMI gain, MRMI efficiency, MBI gain and MBI efficiency were
      analyzed.
observational model: Cohort
time perspective: Cross-Sectional
measure: Change in Modified Rivermead Mobility Index (MRMI)
time frame: baseline and 1 month
description: MRMI was used to assess subjects' mobility in this study. The MRMI is highly reliable between raters (ICC= 0.98) and has high internal consistency (Cronbach's alpha = 0.93) to early stage patients with stroke. The MRMI consists of eight test items, including turning over, changing from lying to sitting, maintaining sitting balance, going from sitting to standing, standing, transferring, walking indoors, and climbing stairs. The score of MRMI range from 0 to 40. One main characteristic of the MRMI is that participants are scored by observation of their performance on the items directly. Change in MRMI i.e. MRMI gain is the difference between pre-discharge MRMI and admission MRMI.
measure: Change in Modified Barthel Index (MBI) Gain
time frame: baseline and 1 month
description: MBI was used to assess subjects' basic activities of daily living (ADL) in this study. MBI measures the subject's performance on ten functional items including self-care, continence, and locomotion. The values assigned to each item are based on the amount of physical assistance required to perform the task and added to give a total score ranging from 0 to 100 (0 = fully dependent, 100 = fully independent) with higher score indicating higher levels of physical function. There are no subtotal score because there are no sub-scales. The internal consistency reliability coefficient for MBI is 0.90. Change in MBI i.e. MBI gain is the difference between pre- discharge MBI and admission MBI.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Tai Po Hospital
investigator full name: Bryan Ping Ho CHUNG
investigator title: Principal Investigator of Physiotherapy Department
mesh term: Stroke