<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/NCT01674452</url>
  </required_header>
  <id_info>
    <org_study_id>USPNEC003</org_study_id>
    <nct_id>NCT01674452</nct_id>
  </id_info>
  <brief_title>Home-based Exercises for Patients With Stroke</brief_title>
  <official_title>Home-based Exercises for Patients With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is the development and the implementation of a new protocol about&#xD;
      home-based exercises, supported by an illustrated manual, for the treatment of individuals&#xD;
      with stroke.&#xD;
&#xD;
      The hypothesis is that this group of patients who are going to carry out the training of this&#xD;
      study protocol are going to show improvement in measured parameters (functionality and&#xD;
      physical performance), which allows this protocol to be improved and published as a proposal&#xD;
      of physiotherapeutic treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Program Development: 27 exercises were selected, based on the most frequent motor&#xD;
           alterations present in hemiparesis. Three modes were created for each exercise: assisted&#xD;
           active, active and resisted active executions. Besides explanatory text, there were&#xD;
           illustrative photos for all exercises and their modes.&#xD;
&#xD;
        2. Program Execution: All groups were submitted to a motor evaluation utilizing the&#xD;
           Fugl-Meyer Assessment (FMA) and functional evaluation utilizing the Functional&#xD;
           independence measure (FIM). After assessment, for the patients of the home-based&#xD;
           exercise group (HBG) a group of home exercises was selected for each patient; these&#xD;
           exercises were explained and performed one by one. The home-exercises were re-executed&#xD;
           at each fortnightly visit, when any necessary correction was made. The next steps&#xD;
           stipulated by the manual were taken, providing the patients with more complex exercises&#xD;
           according to their progress. The patients in the supervised exercise training group&#xD;
           (SEG) participated in supervised individual exercise sessions two times per week. A&#xD;
           physical therapist supervised these sessions. Exercise sessions included: 30 minutes of&#xD;
           global exercises that involved stretching, range of motion, muscle strengthen and&#xD;
           another 30 minutes of functional training (gait, balance and use of the arm in daily&#xD;
           activities).The control group (CG) was assessed but reluctant or unable to regularly&#xD;
           attend a supervised exercise program. The groups were reassessed after six months.&#xD;
&#xD;
        3. Program assessment: The Fugl-Meyer Assessment score and the Functional independence&#xD;
           measure score, measured at baseline and after six months, were compared between the&#xD;
           groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">February 2011</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>Functional Independence Measure</measure>
    <time_frame>6 months</time_frame>
    <description>Functional Independence Measure (FIM) it is an 18-item ordinal scale with seven levels ranging from 1 (total dependence) to 7 (total independence).FIM can be subdivided into a 13-item motor subscale (eating, grooming, bathing, dressing upper body, dressing lower body, personal hygiene, bladder control, bowel control, transfer to tub/shower, walk or wheelchair, stairs) and 5-item cognitive subscale (comprehension, expression, social interaction, problem solving, memory).The motor and cognitive sub-scales scores range from 13 to 91(motor-FIM) and from 5 to 35 (cognitive-FIM). The maximum total score is 126.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>motor performance, Fugl-Meyer scale</measure>
    <time_frame>6 months</time_frame>
    <description>The Fugl-Meyer physical performance scale assesses five dimensions of impairment, including three aspects of motor control, such as the amplitude of joint movement, pain, sensitivity, motor impairment of the upper and lower extremities and balance. The data are scored in an ordinal scale of 3 (0=no performance; 2=complete performance) applied to each item7. The total motor score is equal to the classification of the upper limb (UL) plus the lower limb (LL), corresponding to 100 total scores (UL=66, LL=34). The total FM score, including the other items, corresponds to 226 scores in the final sum.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Cerebrovascular Disorders</condition>
  <condition>Brain Infarction</condition>
  <condition>Brain Ischemia</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>home-based group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>supervised exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group:no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>home-based group (HBG)</intervention_name>
    <description>Participants in the home-based group (HBG) were advised to exercise, a minimum of 4 times per week, but they were encouraged to exercise a total of 5-7 days per week. After individual assessment, a group of home-exercise selected of the manual was explained and performed one by one. The home-exercises were re-executed at each fortnightly visit, when necessary corrections were made and the next step stipulated by manual was taken, according to the patient's progress.</description>
    <arm_group_label>home-based group</arm_group_label>
    <other_name>Home-based exercise supported by an illustrated manual</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>supervised exercise group (SEG)</intervention_name>
    <description>Patients in the supervised exercise training group (SEG) participated in supervised individual exercise sessions 2 times per week. A physical therapist supervised these sessions. Exercise sessions included: 30 minutes of global exercises that involved stretching, range of motion, muscle strengthen and another 30 minutes of functional training (gait, balance and use of the arm in daily activities).</description>
    <arm_group_label>supervised exercise group</arm_group_label>
    <other_name>Conventional supervised exercise training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of stroke, confirmed by clinical and radiological evidence&#xD;
&#xD;
          -  Ability to understand and follow commands&#xD;
&#xD;
          -  willing and able to regularly attend a supervised exercise program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cognitive impairment&#xD;
&#xD;
          -  Commodity that preclude them from undergoing training and assessment&#xD;
&#xD;
          -  Neurological disease other than stroke&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Elisa P Piemonte</last_name>
    <role>Study Director</role>
    <affiliation>Department of Physical therapy,School of Medicine, University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tatiana P Oliveira</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical therapy, School of Medicine, University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Physical therapy, Medicine School of University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>05360-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 24, 2012</last_update_submitted>
  <last_update_submitted_qc>August 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Maria Elisa Pimentel Piemonte</investigator_full_name>
    <investigator_title>PT; PhD</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Exercise and Physical Fitness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Brain Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Ischemia</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/NCT01674452
org study id: USPNEC003
nct id: NCT01674452
lead sponsor: 
has dmc: Yes
The aim of this study is the development and the implementation of a new protocol about
      home-based exercises, supported by an illustrated manual, for the treatment of individuals
      with stroke.

      The hypothesis is that this group of patients who are going to carry out the training of this
      study protocol are going to show improvement in measured parameters (functionality and
      physical performance), which allows this protocol to be improved and published as a proposal
      of physiotherapeutic treatment.
1. Program Development: 27 exercises were selected, based on the most frequent motor
           alterations present in hemiparesis. Three modes were created for each exercise: assisted
           active, active and resisted active executions. Besides explanatory text, there were
           illustrative photos for all exercises and their modes.

        2. Program Execution: All groups were submitted to a motor evaluation utilizing the
           Fugl-Meyer Assessment (FMA) and functional evaluation utilizing the Functional
           independence measure (FIM). After assessment, for the patients of the home-based
           exercise group (HBG) a group of home exercises was selected for each patient; these
           exercises were explained and performed one by one. The home-exercises were re-executed
           at each fortnightly visit, when any necessary correction was made. The next steps
           stipulated by the manual were taken, providing the patients with more complex exercises
           according to their progress. The patients in the supervised exercise training group
           (SEG) participated in supervised individual exercise sessions two times per week. A
           physical therapist supervised these sessions. Exercise sessions included: 30 minutes of
           global exercises that involved stretching, range of motion, muscle strengthen and
           another 30 minutes of functional training (gait, balance and use of the arm in daily
           activities).The control group (CG) was assessed but reluctant or unable to regularly
           attend a supervised exercise program. The groups were reassessed after six months.

        3. Program assessment: The Fugl-Meyer Assessment score and the Functional independence
           measure score, measured at baseline and after six months, were compared between the
           groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Functional Independence Measure
time frame: 6 months
description: Functional Independence Measure (FIM) it is an 18-item ordinal scale with seven levels ranging from 1 (total dependence) to 7 (total independence).FIM can be subdivided into a 13-item motor subscale (eating, grooming, bathing, dressing upper body, dressing lower body, personal hygiene, bladder control, bowel control, transfer to tub/shower, walk or wheelchair, stairs) and 5-item cognitive subscale (comprehension, expression, social interaction, problem solving, memory).The motor and cognitive sub-scales scores range from 13 to 91(motor-FIM) and from 5 to 35 (cognitive-FIM). The maximum total score is 126.
measure: motor performance, Fugl-Meyer scale
time frame: 6 months
description: The Fugl-Meyer physical performance scale assesses five dimensions of impairment, including three aspects of motor control, such as the amplitude of joint movement, pain, sensitivity, motor impairment of the upper and lower extremities and balance. The data are scored in an ordinal scale of 3 (0=no performance; 2=complete performance) applied to each item7. The total motor score is equal to the classification of the upper limb (UL) plus the lower limb (LL), corresponding to 100 total scores (UL=66, LL=34). The total FM score, including the other items, corresponds to 226 scores in the final sum.
arm group label: home-based group
arm group type: Experimental
arm group label: supervised exercise group
arm group type: Active Comparator
arm group label: control
arm group type: No Intervention
description: Control group:no intervention
intervention type: Behavioral
intervention name: home-based group (HBG)
description: Participants in the home-based group (HBG) were advised to exercise, a minimum of 4 times per week, but they were encouraged to exercise a total of 5-7 days per week. After individual assessment, a group of home-exercise selected of the manual was explained and performed one by one. The home-exercises were re-executed at each fortnightly visit, when necessary corrections were made and the next step stipulated by manual was taken, according to the patient's progress.
arm group label: home-based group
other name: Home-based exercise supported by an illustrated manual
intervention type: Behavioral
intervention name: supervised exercise group (SEG)
description: Patients in the supervised exercise training group (SEG) participated in supervised individual exercise sessions 2 times per week. A physical therapist supervised these sessions. Exercise sessions included: 30 minutes of global exercises that involved stretching, range of motion, muscle strengthen and another 30 minutes of functional training (gait, balance and use of the arm in daily activities).
arm group label: supervised exercise group
other name: Conventional supervised exercise training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Maria Elisa P Piemonte
role: Study Director
affiliation: Department of Physical therapy,School of Medicine, University of Sao Paulo
last name: Tatiana P Oliveira
role: Principal Investigator
affiliation: Department of Physical therapy, School of Medicine, University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Maria Elisa Pimentel Piemonte
investigator title: PT; PhD
mesh term: Stroke
mesh term: Cerebrovascular Disorders
mesh term: Brain Ischemia
mesh term: Brain Infarction
mesh term: Infarction
mesh term: Ischemia