<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/NCT04402736</url>
  </required_header>
  <id_info>
    <org_study_id>2018LS112</org_study_id>
    <nct_id>NCT04402736</nct_id>
  </id_info>
  <brief_title>Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke</brief_title>
  <official_title>Feasibility and Effectiveness of a Modified Barthel Index-based Rehabilitation Nursing Program for Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang 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>
      In the clinical setting, it is difficult to obtain effective rehabilitation during the acute&#xD;
      phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a&#xD;
      limitation in number and variety of rehabilitation professionals in Low- and middle-income&#xD;
      countries. It is necessary to shift tasks to other healthcare providers who are trained to&#xD;
      provide rehabilitation like nurses. The purpose of this study is to examine the feasibility&#xD;
      and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute&#xD;
      stroke inpatients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ischemic stroke is the main cause of disability in the world. More than 70% of stroke&#xD;
      patients show various degrees of neural function impairment. Early rehabilitation in acute&#xD;
      phase is beneficial for improving patient's activity of daily livings and motor function.&#xD;
      However, it is difficult to obtain effective rehabilitation during the acute phase of stroke&#xD;
      because of the insufficiency of professional rehabilitation therapists in stroke wards in&#xD;
      China. The investigators assume that implementing program based on modified Barthel Index can&#xD;
      realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The&#xD;
      present study is to conduct quasi-experimental research to confirm the feasibility and&#xD;
      effectiveness of nursing-directed precision rehabilitation in acute stroke patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2018</start_date>
  <completion_date type="Actual">November 20, 2018</completion_date>
  <primary_completion_date type="Actual">October 29, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline the Modified Barthel Index (MBI) on day 7</measure>
    <time_frame>Day 0 and day 7</time_frame>
    <description>The MBI score ranges from 0 to 100, the higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the motor assessment scale (MAS) on day 7</measure>
    <time_frame>Day 0 and day 7</time_frame>
    <description>The MAS scale excluding general tonus, may be summed to provide an overall score out of a possible 48 points and the higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7</measure>
    <time_frame>Day 0 and day 7</time_frame>
    <description>The NIHSS scale ranges from 0 to 42, and the higher scores mean a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The completion rate</measure>
    <time_frame>Day 7</time_frame>
    <description>The completion means participants completed all the study stage and all the data collection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The adverse events rate</measure>
    <time_frame>Day 7</time_frame>
    <description>The adverse events including pneumonia, stroke progression or recurrent, fall.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <condition>Nursing</condition>
  <arm_group>
    <arm_group_label>Modified Barthel Index-based rehabilitation nursing program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received the Modified Barthel Index based rehabilitation nursing from qualified nurses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients received the usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The modified Barthel Index-based rehabilitation nursing program</intervention_name>
    <description>The intervention with the program based on the MBI classified function of patients into five levels, with every 20 points as a level, Each level corresponds to different training items. Training items included self-care training and training in transfer activities, sitting balance, walking, and sit-to-stand, etc. Each training session lasting at least 30 minutes, two sessions per day, for seven continuous days. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.</description>
    <arm_group_label>Modified Barthel Index-based rehabilitation nursing program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Patients in the control group received clinical usual care including the activities of daily living assessment, early mobilization guide and health education. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with ischemic stroke and met the diagnostic criteria of the World Health&#xD;
             Organization;&#xD;
&#xD;
          -  initial stroke within seven days, with limb dysfunction;&#xD;
&#xD;
          -  NIHSS scale consciousness scores of 0 or 1;&#xD;
&#xD;
          -  provided informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incomplete clinical data;&#xD;
&#xD;
          -  having a physical disability or other diseases that affect the limb function;&#xD;
&#xD;
          -  having cognitive impairment or other diseases that interfere with participation;&#xD;
&#xD;
          -  having serious cardiopulmonary dysfunction or another disease that requires absolute&#xD;
             bed rest;&#xD;
&#xD;
          -  having progressive stroke or having severe complications that patients drop the study&#xD;
             before completion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jingfen Jin, Master</last_name>
    <role>Study Director</role>
    <affiliation>The Second Affiliated Hospital of Medical College of Zhejiang University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 16, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic 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/NCT04402736
org study id: 2018LS112
nct id: NCT04402736
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the clinical setting, it is difficult to obtain effective rehabilitation during the acute
      phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a
      limitation in number and variety of rehabilitation professionals in Low- and middle-income
      countries. It is necessary to shift tasks to other healthcare providers who are trained to
      provide rehabilitation like nurses. The purpose of this study is to examine the feasibility
      and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute
      stroke inpatients.
Ischemic stroke is the main cause of disability in the world. More than 70% of stroke
      patients show various degrees of neural function impairment. Early rehabilitation in acute
      phase is beneficial for improving patient's activity of daily livings and motor function.
      However, it is difficult to obtain effective rehabilitation during the acute phase of stroke
      because of the insufficiency of professional rehabilitation therapists in stroke wards in
      China. The investigators assume that implementing program based on modified Barthel Index can
      realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The
      present study is to conduct quasi-experimental research to confirm the feasibility and
      effectiveness of nursing-directed precision rehabilitation in acute stroke patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline the Modified Barthel Index (MBI) on day 7
time frame: Day 0 and day 7
description: The MBI score ranges from 0 to 100, the higher scores mean a better outcome.
measure: Change from baseline the motor assessment scale (MAS) on day 7
time frame: Day 0 and day 7
description: The MAS scale excluding general tonus, may be summed to provide an overall score out of a possible 48 points and the higher scores mean a better outcome.
measure: Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7
time frame: Day 0 and day 7
description: The NIHSS scale ranges from 0 to 42, and the higher scores mean a worse outcome.
measure: The completion rate
time frame: Day 7
description: The completion means participants completed all the study stage and all the data collection.
measure: The adverse events rate
time frame: Day 7
description: The adverse events including pneumonia, stroke progression or recurrent, fall.
arm group label: Modified Barthel Index-based rehabilitation nursing program
arm group type: Experimental
description: Patients received the Modified Barthel Index based rehabilitation nursing from qualified nurses.
arm group label: Usual care
arm group type: Other
description: Patients received the usual care.
intervention type: Behavioral
intervention name: The modified Barthel Index-based rehabilitation nursing program
description: The intervention with the program based on the MBI classified function of patients into five levels, with every 20 points as a level, Each level corresponds to different training items. Training items included self-care training and training in transfer activities, sitting balance, walking, and sit-to-stand, etc. Each training session lasting at least 30 minutes, two sessions per day, for seven continuous days. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
arm group label: Modified Barthel Index-based rehabilitation nursing program
intervention type: Behavioral
intervention name: Usual care
description: Patients in the control group received clinical usual care including the activities of daily living assessment, early mobilization guide and health education. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jingfen Jin, Master
role: Study Director
affiliation: The Second Affiliated Hospital of Medical College of Zhejiang University
facility: 
country: China
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke