<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/NCT03251209</url>
  </required_header>
  <id_info>
    <org_study_id>1.978.586/2017</org_study_id>
    <nct_id>NCT03251209</nct_id>
  </id_info>
  <brief_title>Mental Practice in Post-stroke Subjects</brief_title>
  <official_title>Influence of Mental Practice on Manual Dexterity Associated Before and After Physical Practice in Patients With Stroke Sequelae</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio Grande do Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</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>
      Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes&#xD;
      changes that limit the individual in his ability to maintain an active social life. Mental&#xD;
      Practice (MP) consists of the internal reproduction of an event, which is repeated&#xD;
      extensively in order to learn or improve an already known skill. The objective of the study&#xD;
      is evaluate the effects of the physical practice associated with PM, on paretic MS. Subjects&#xD;
      with unilateral stroke over 6 months, age&gt; 18 years and who were able to hold objects will be&#xD;
      selected. Subjects with painful conditions that affected exercise performance,&gt; 3 spasticity&#xD;
      by Ashworth, and cognitive deficit suggested by the Mini Mental State Examination will be&#xD;
      excluded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are 3 study protocols. The MP protocol 1 comprise 4 steps: 1) 5 minutes of global&#xD;
      relaxation; 2) Video therapy, being 2 minutes / task (4 distinct tasks: stacking cubes,&#xD;
      opposition of fingers with precision gripping, passing water from one glass to another,&#xD;
      sequencing of bottles); 3) MP: think about the tasks assisted in the video for 5 minutes /&#xD;
      task. 4) Physical Practice: reproduce through the motor execution, the activities assisted in&#xD;
      the video (5 minutes / task). The MP protocol 2 was the same, changing the order: first&#xD;
      physical practice and after MP. For the protocol 3 without PM, step 3 was suppressed,&#xD;
      remaining the remaining steps. There were 15 sessions, 2x / week, for 1 hour. The Fugl-Meyer&#xD;
      (FM) Scales, Ashworth Modified Scale (EMA), Functional Independence Measurement (MIF), Action&#xD;
      Research Arm Test (ARAt), Box and block task (BBT) and Theory of mind battery (ToM) will be&#xD;
      applied before and after the sessions, and in 3 months follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 10, 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Scale</measure>
    <time_frame>Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).</time_frame>
    <description>Sensory-motor impairment of upper limb</description>
  </primary_outcome>
  <primary_outcome>
    <measure>surface electromyography</measure>
    <time_frame>change from baseline muscle activity at 8 weeks and 3 months (follow-up)</time_frame>
    <description>Short radial extensor of the carpus and superficial flexor of the fingers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional independence measure (FIM)</measure>
    <time_frame>change from baseline functional independence at 8 weeks and 3 months (follow-up)</time_frame>
    <description>assess the dependence of others for activities of daily living</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>change from baseline dexterity at 8 weeks and 3 months (follow-up)</time_frame>
    <description>functional test of upper limb</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Box and Block test (BBT)</measure>
    <time_frame>change from baseline dexterity at 8 weeks and 3 months (follow-up)</time_frame>
    <description>manual dexterity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Movement Imagery Questionnaire-Revised second version (MIQ-RS)</measure>
    <time_frame>change from baseline ability to imagine at 8 weeks</time_frame>
    <description>evaluate the ability to imagine thick movements related to the upper and include movements referring to the ADLs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)</measure>
    <time_frame>change from baseline capacity of imagination at 8 weeks</time_frame>
    <description>assessing visual and kinesthetic motor imagery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-mental State Examination</measure>
    <time_frame>baseline</time_frame>
    <description>evaluation of cognition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Theory of Mind Task Battery (ToM)</measure>
    <time_frame>change from mental function baseline at 8 weeks</time_frame>
    <description>evaluation of mental function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified ashworth scale (MAS)</measure>
    <time_frame>change fom baseline muscle tone at 8 weeks and 3 months (follow-up)</time_frame>
    <description>evaluation of muscle tone of upper limb</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Stroke Sequelae</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post-stroke participants receive the mental practice before the physical practice. The activities will be presented in a videotherapy way.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post-stroke participants receive the mental practice after the physical practice. The activities will be presented in a videotherapy way.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Post-stroke participants receive only physical practice. The activities will be presented in a videotherapy way.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical practice</intervention_name>
    <description>Physical Practice: reproduce through the motor execution (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles), the activities assisted in the video (5 minutes / task).</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mental practice</intervention_name>
    <description>Mental practice: think about the tasks watched in the videotherapy (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles) for 5 minutes / task.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Videotherapy</intervention_name>
    <description>Videotherapy, being 2 minutes per task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles)</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of stroke, ischemic or hemorrhagic, for more than 6 months, age&#xD;
             above 18 years, unilateral involvement and are able to hold objects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Painful conditions that affect the ability to perform the proposed exercises,&#xD;
             spasticity greater than 3 by the Ashworth Scale and cognitive deficits that will be&#xD;
             evaluated by the Mini Mental State Examination (MMSE)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roberta O Cacho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio Grande do Norte</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Health Science - Facisa/UFRN</name>
      <address>
        <city>Santa Cruz</city>
        <state>Rio Grande do Norte</state>
        <zip>59200000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Roberta de Oliveira Cacho</investigator_full_name>
    <investigator_title>PhD</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>
  </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/NCT03251209
org study id: 1.978.586/2017
nct id: NCT03251209
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes
      changes that limit the individual in his ability to maintain an active social life. Mental
      Practice (MP) consists of the internal reproduction of an event, which is repeated
      extensively in order to learn or improve an already known skill. The objective of the study
      is evaluate the effects of the physical practice associated with PM, on paretic MS. Subjects
      with unilateral stroke over 6 months, age> 18 years and who were able to hold objects will be
      selected. Subjects with painful conditions that affected exercise performance,> 3 spasticity
      by Ashworth, and cognitive deficit suggested by the Mini Mental State Examination will be
      excluded.
There are 3 study protocols. The MP protocol 1 comprise 4 steps: 1) 5 minutes of global
      relaxation; 2) Video therapy, being 2 minutes / task (4 distinct tasks: stacking cubes,
      opposition of fingers with precision gripping, passing water from one glass to another,
      sequencing of bottles); 3) MP: think about the tasks assisted in the video for 5 minutes /
      task. 4) Physical Practice: reproduce through the motor execution, the activities assisted in
      the video (5 minutes / task). The MP protocol 2 was the same, changing the order: first
      physical practice and after MP. For the protocol 3 without PM, step 3 was suppressed,
      remaining the remaining steps. There were 15 sessions, 2x / week, for 1 hour. The Fugl-Meyer
      (FM) Scales, Ashworth Modified Scale (EMA), Functional Independence Measurement (MIF), Action
      Research Arm Test (ARAt), Box and block task (BBT) and Theory of mind battery (ToM) will be
      applied before and after the sessions, and in 3 months follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fugl-Meyer Scale
time frame: Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).
description: Sensory-motor impairment of upper limb
measure: surface electromyography
time frame: change from baseline muscle activity at 8 weeks and 3 months (follow-up)
description: Short radial extensor of the carpus and superficial flexor of the fingers
measure: Functional independence measure (FIM)
time frame: change from baseline functional independence at 8 weeks and 3 months (follow-up)
description: assess the dependence of others for activities of daily living
measure: Action Research Arm Test (ARAT)
time frame: change from baseline dexterity at 8 weeks and 3 months (follow-up)
description: functional test of upper limb
measure: Box and Block test (BBT)
time frame: change from baseline dexterity at 8 weeks and 3 months (follow-up)
description: manual dexterity
measure: Movement Imagery Questionnaire-Revised second version (MIQ-RS)
time frame: change from baseline ability to imagine at 8 weeks
description: evaluate the ability to imagine thick movements related to the upper and include movements referring to the ADLs.
measure: Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)
time frame: change from baseline capacity of imagination at 8 weeks
description: assessing visual and kinesthetic motor imagery
measure: Mini-mental State Examination
time frame: baseline
description: evaluation of cognition
measure: Theory of Mind Task Battery (ToM)
time frame: change from mental function baseline at 8 weeks
description: evaluation of mental function
measure: Modified ashworth scale (MAS)
time frame: change fom baseline muscle tone at 8 weeks and 3 months (follow-up)
description: evaluation of muscle tone of upper limb
arm group label: Group 1
arm group type: Experimental
description: Post-stroke participants receive the mental practice before the physical practice. The activities will be presented in a videotherapy way.
arm group label: Group 2
arm group type: Experimental
description: Post-stroke participants receive the mental practice after the physical practice. The activities will be presented in a videotherapy way.
arm group label: Group 3
arm group type: Active Comparator
description: Post-stroke participants receive only physical practice. The activities will be presented in a videotherapy way.
intervention type: Other
intervention name: Physical practice
description: Physical Practice: reproduce through the motor execution (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles), the activities assisted in the video (5 minutes / task).
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
intervention type: Other
intervention name: Mental practice
description: Mental practice: think about the tasks watched in the videotherapy (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles) for 5 minutes / task.
arm group label: Group 1
arm group label: Group 2
intervention type: Other
intervention name: Videotherapy
description: Videotherapy, being 2 minutes per task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles)
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberta O Cacho, PhD
role: Principal Investigator
affiliation: Universidade Federal do Rio Grande do Norte
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Roberta de Oliveira Cacho
investigator title: PhD
mesh term: Stroke
sharing ipd: No