<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/NCT03292211</url>
  </required_header>
  <id_info>
    <org_study_id>201706073RINB</org_study_id>
    <nct_id>NCT03292211</nct_id>
  </id_info>
  <brief_title>The Effect of Early Mobilization in Mild to Moderate Hemorrhagic Stroke</brief_title>
  <official_title>Comparing the Benefits of Functional Recovery Between the Early Mobilization and Early Conventional Intervention After Stroke for the Patients With Mild to Moderate Hemorrhagic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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 aims to examine the outcomes of early mobilization and early intervention within&#xD;
      24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care&#xD;
      unit within 24 hours after stroke. The patients after hemorrhagic stroke who undergo early&#xD;
      intervention only will be compared with those who also receive early mobilization in order to&#xD;
      determine if the early mobilization intervention results in earlier or more effective&#xD;
      recovery of postural stability, activities of daily living function, or motor capacity.&#xD;
&#xD;
      The participants will be randomly assigned to the following two groups: (1) the early&#xD;
      mobilization (+early rehabilitation) group and (2) the early rehabilitation group.The&#xD;
      measurement parameters will be collected before the intervention (basic parameters), two&#xD;
      weeks after the stroke, four weeks after the stroke and three months after the stroke. SPSS&#xD;
      (version 17.0) will be used to carry out repeated measures analysis of variance (repeated&#xD;
      ANOVA) to compare the differences between the groups at different time points (including&#xD;
      basic values and follow-up values). For statistical significance, Bonferroni correction will&#xD;
      be applied for the post-hoc analysis of the groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early intervention has been proven to enhance post-stroke functional recovery. Recent studies&#xD;
      have proposed that early mobilization (out-of-bed activities) also contributes to an&#xD;
      individual's functional improvement after stroke. However, studies on early intervention&#xD;
      after stroke have mainly investigated patients with ischemic stroke, while tending to exclude&#xD;
      patients with hemorrhagic stroke who were admitted to intensive care units. The main reason&#xD;
      for this is the difference between hemorrhagic and ischemic strokes in terms of their&#xD;
      mechanisms and treatment methods. Hemorrhagic stroke is characterized by higher severity and&#xD;
      fatality rates, and there is a general lack of research on early rehabilitation and&#xD;
      mobilization after hemorrhagic strokes. To our knowledge, there have been no previous studies&#xD;
      that have simultaneously compared the impact of early mobilization and early rehabilitation&#xD;
      starting at the same time on the motor recovery of patients after intracranial hemorrhage.&#xD;
      Thus, this study aims to examine the outcomes of early mobilization and intervention within&#xD;
      24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care&#xD;
      unit within 24 hours after stroke. The patients will be compared to identify differences in&#xD;
      the recovery of postural stability and functional abilities two weeks, four weeks and three&#xD;
      months after stroke.&#xD;
&#xD;
      The participants will be randomly assigned to the following two groups: (1) the early&#xD;
      mobilization (+early rehabilitation) group and (2) the early rehabilitation group. The early&#xD;
      mobilization group will receive early mobilization intervention within24-72 hours after&#xD;
      stroke while being monitored by medical equipment. In early mobilization group, this&#xD;
      intervention program will most include early out-of-bed activities (that is, rolling and&#xD;
      sitting at the edge of the bed). The early rehabilitation group will undergo only&#xD;
      conventional early in-bed activities in the stroke center.&#xD;
&#xD;
      All the outcome measures will be collected at baseline (pre-intervention), 2 weeks after&#xD;
      stroke, 4 weeks after stroke and three months after stroke.The results will be analyzed with&#xD;
      SPSS (IBM SPSS Statistics 17, Chicago, IL, USA). Repeated measures analysis of variance&#xD;
      (repeated ANOVA) and the Chi-square test for categorical variables will be used for comparing&#xD;
      the outcome data. If there are significant interactions, a post hoc test with Bonferroni&#xD;
      correction will be used to examine group differences within a time condition. A p value &lt;&#xD;
      0.05 will be considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">February 10, 2019</completion_date>
  <primary_completion_date type="Actual">November 9, 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the score-change of the Functional Independence Measure (FIM) assessment for daily living function</measure>
    <time_frame>baseline, 2-week, 4-week and three months after stroke</time_frame>
    <description>The functional independence of patient's capacities in terms of activity of daily living. The instrument assesses motor domain including dependence in self-care, sphincter management, transfer, locomotion as well as cognition domain including communication, social interaction and cognition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the number of days required to reach a sitting&gt;5 minutes milestone</measure>
    <time_frame>baseline to within 3 months after stroke</time_frame>
    <description>The milestone will be the ability to sit on the edge of a bed with the feet touching the floor without support &gt; 5 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of days required to reach a standing&gt;1 minute milestone</measure>
    <time_frame>baseline to within 3 months after stroke</time_frame>
    <description>The milestone will be the ability to stand without support for longer than 1 minute and with the feet freely positioned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of days required to reach a walking&gt;50 meters milestone using the functional ambulation category (FAC)</measure>
    <time_frame>baseline to within 3 months after stroke</time_frame>
    <description>The milestone will consist of walking on a level surface for a minimum of 50 meters with/without an assistive device while under supervision or required support level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of serious adverse events</measure>
    <time_frame>baseline to within 3 months after stroke</time_frame>
    <description>Immobility-related and neurological serious adverse events include both fatal and non-fatal complications; immobility-related events include pulmonary embolism, deep-vein thrombosis, urinary tract infection, pressure sores, pneumonia; and neurological events include stroke progression and recurrent stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score-change of the Postural Assessment Scale for Stroke Patients (PASS)</measure>
    <time_frame>baseline, 2-week, 4-week and three months after stroke</time_frame>
    <description>12 four-level items of varying difficulty with a maximum score of 36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the score-change of systolic blood pressure (SBP) during the acute phase</measure>
    <time_frame>up to 2 weeks after stroke</time_frame>
    <description>recorded the absolute SBP values over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of days required to stay in the stroke center</measure>
    <time_frame>baseline to within 3 months after stroke</time_frame>
    <description>the length of stay in the stroke center</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hemorrhagic Stroke</condition>
  <arm_group>
    <arm_group_label>early mobilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>early mobilization group will commence rehabilitation consisting of out-of-bed mobilization (including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>early standard intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>early standard intervention included bed exercises including the joint range of motion exercise, bridge exercise, the straight leg raising exercise, stretching exercises, and the facilitation techniques during the period in a stroke center.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>early mobilization</intervention_name>
    <description>early out-of-bed activities including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.within three days after stroke while being monitored by medical equipment.</description>
    <arm_group_label>early mobilization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>early standard intervention</intervention_name>
    <description>Conventional early in-bed activities within three days after stroke</description>
    <arm_group_label>early standard intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion criteria will be as follows:&#xD;
&#xD;
          1. patients with a first time intracerebral (either cortical or subcortical) hemorrhage&#xD;
             with unilateral hemiparesis/ hemiplegia confirmed by magnetic resonance imaging or&#xD;
             computed tomography;&#xD;
&#xD;
          2. patients with no contraindications to being mobilized (early intervention) within 24&#xD;
             hours of stroke onset (based on the medical team's clinical judgment: including&#xD;
             systolic blood pressure (SBP)&lt;160mmHg in resting; resting heart rate (HR)&lt;130 bpm; no&#xD;
             hydrocephalus; 80&lt; mean arterial pressure (MAP)&lt;110 mmHg before intervention);&#xD;
&#xD;
          3. patients with National Institutes of Health Stroke Scale (NIHSS) scores at admission&#xD;
             ranging from 1 to 20;&#xD;
&#xD;
          4. patients with total activity of living independence pre-stroke; and&#xD;
&#xD;
          5. patients between 20 and 80 years old.&#xD;
&#xD;
        The exclusion criteria will be as follows:&#xD;
&#xD;
          1. patients with mild to moderate deficits as described above (3);&#xD;
&#xD;
          2. patients who are unable to complete the baseline survey because of serious aphasia,&#xD;
             language difficulties, or cognitive deficits;&#xD;
&#xD;
          3. patients with other medical conditions, such as severe heart failure, acute coronary&#xD;
             syndrome, or lower-limb disorders, that prevent early mobilization; and&#xD;
&#xD;
          4. patients who are unable to provide informed consent. In addition, we will exclude&#xD;
             those showing rapid early deterioration of symptoms, as well as those with a&#xD;
             concurrent diagnosis of rapidly deteriorating disease (e.g., terminal cancer).&#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>Jiann-Shing Jeng</last_name>
    <role>Principal Investigator</role>
    <affiliation>NTUH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early mobilization</keyword>
  <keyword>Acute stroke</keyword>
  <keyword>Early intervention</keyword>
  <keyword>Early mobilization therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hemorrhagic 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/NCT03292211
org study id: 201706073RINB
nct id: NCT03292211
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to examine the outcomes of early mobilization and early intervention within
      24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care
      unit within 24 hours after stroke. The patients after hemorrhagic stroke who undergo early
      intervention only will be compared with those who also receive early mobilization in order to
      determine if the early mobilization intervention results in earlier or more effective
      recovery of postural stability, activities of daily living function, or motor capacity.

      The participants will be randomly assigned to the following two groups: (1) the early
      mobilization (+early rehabilitation) group and (2) the early rehabilitation group.The
      measurement parameters will be collected before the intervention (basic parameters), two
      weeks after the stroke, four weeks after the stroke and three months after the stroke. SPSS
      (version 17.0) will be used to carry out repeated measures analysis of variance (repeated
      ANOVA) to compare the differences between the groups at different time points (including
      basic values and follow-up values). For statistical significance, Bonferroni correction will
      be applied for the post-hoc analysis of the groups.
Early intervention has been proven to enhance post-stroke functional recovery. Recent studies
      have proposed that early mobilization (out-of-bed activities) also contributes to an
      individual's functional improvement after stroke. However, studies on early intervention
      after stroke have mainly investigated patients with ischemic stroke, while tending to exclude
      patients with hemorrhagic stroke who were admitted to intensive care units. The main reason
      for this is the difference between hemorrhagic and ischemic strokes in terms of their
      mechanisms and treatment methods. Hemorrhagic stroke is characterized by higher severity and
      fatality rates, and there is a general lack of research on early rehabilitation and
      mobilization after hemorrhagic strokes. To our knowledge, there have been no previous studies
      that have simultaneously compared the impact of early mobilization and early rehabilitation
      starting at the same time on the motor recovery of patients after intracranial hemorrhage.
      Thus, this study aims to examine the outcomes of early mobilization and intervention within
      24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care
      unit within 24 hours after stroke. The patients will be compared to identify differences in
      the recovery of postural stability and functional abilities two weeks, four weeks and three
      months after stroke.

      The participants will be randomly assigned to the following two groups: (1) the early
      mobilization (+early rehabilitation) group and (2) the early rehabilitation group. The early
      mobilization group will receive early mobilization intervention within24-72 hours after
      stroke while being monitored by medical equipment. In early mobilization group, this
      intervention program will most include early out-of-bed activities (that is, rolling and
      sitting at the edge of the bed). The early rehabilitation group will undergo only
      conventional early in-bed activities in the stroke center.

      All the outcome measures will be collected at baseline (pre-intervention), 2 weeks after
      stroke, 4 weeks after stroke and three months after stroke.The results will be analyzed with
      SPSS (IBM SPSS Statistics 17, Chicago, IL, USA). Repeated measures analysis of variance
      (repeated ANOVA) and the Chi-square test for categorical variables will be used for comparing
      the outcome data. If there are significant interactions, a post hoc test with Bonferroni
      correction will be used to examine group differences within a time condition. A p value <
      0.05 will be considered statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: the score-change of the Functional Independence Measure (FIM) assessment for daily living function
time frame: baseline, 2-week, 4-week and three months after stroke
description: The functional independence of patient's capacities in terms of activity of daily living. The instrument assesses motor domain including dependence in self-care, sphincter management, transfer, locomotion as well as cognition domain including communication, social interaction and cognition.
measure: the number of days required to reach a sitting>5 minutes milestone
time frame: baseline to within 3 months after stroke
description: The milestone will be the ability to sit on the edge of a bed with the feet touching the floor without support > 5 minutes.
measure: the number of days required to reach a standing>1 minute milestone
time frame: baseline to within 3 months after stroke
description: The milestone will be the ability to stand without support for longer than 1 minute and with the feet freely positioned.
measure: the number of days required to reach a walking>50 meters milestone using the functional ambulation category (FAC)
time frame: baseline to within 3 months after stroke
description: The milestone will consist of walking on a level surface for a minimum of 50 meters with/without an assistive device while under supervision or required support level
measure: the number of serious adverse events
time frame: baseline to within 3 months after stroke
description: Immobility-related and neurological serious adverse events include both fatal and non-fatal complications; immobility-related events include pulmonary embolism, deep-vein thrombosis, urinary tract infection, pressure sores, pneumonia; and neurological events include stroke progression and recurrent stroke.
measure: the score-change of the Postural Assessment Scale for Stroke Patients (PASS)
time frame: baseline, 2-week, 4-week and three months after stroke
description: 12 four-level items of varying difficulty with a maximum score of 36
measure: the score-change of systolic blood pressure (SBP) during the acute phase
time frame: up to 2 weeks after stroke
description: recorded the absolute SBP values over time
measure: the number of days required to stay in the stroke center
time frame: baseline to within 3 months after stroke
description: the length of stay in the stroke center
arm group label: early mobilization
arm group type: Experimental
description: early mobilization group will commence rehabilitation consisting of out-of-bed mobilization (including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.)
arm group label: early standard intervention
arm group type: Other
description: early standard intervention included bed exercises including the joint range of motion exercise, bridge exercise, the straight leg raising exercise, stretching exercises, and the facilitation techniques during the period in a stroke center.
intervention type: Behavioral
intervention name: early mobilization
description: early out-of-bed activities including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.within three days after stroke while being monitored by medical equipment.
arm group label: early mobilization
intervention type: Behavioral
intervention name: early standard intervention
description: Conventional early in-bed activities within three days after stroke
arm group label: early standard intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jiann-Shing Jeng
role: Principal Investigator
affiliation: NTUH
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
mesh term: Hemorrhagic Stroke