<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/NCT03255590</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00082367</org_study_id>
    <secondary_id>2R01HD053793-09A1</secondary_id>
    <nct_id>NCT03255590</nct_id>
  </id_info>
  <brief_title>Can we Train Patients With Chronic Stroke Out of Abnormal Hand Synergy?</brief_title>
  <official_title>Training and Non-Invasive Brain Stimulation in Chronic Stroke Reduce Abnormal Hand Synergy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study plans to determine whether training can change abnormal flexion synergy in chronic&#xD;
      stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the current study is to investigate whether motor training in chronic stroke&#xD;
      patients can change their abnormal flexion synergy. The investigators will study chronic&#xD;
      stroke patients , who are defined as patients that sustained a stroke at least 6 months prior&#xD;
      to our testing date.&#xD;
&#xD;
      Three functional aspects of each finger will be tested: maximal voluntary contraction (MVC),&#xD;
      finger dexterity, and hand posture.&#xD;
&#xD;
      Prior to intervention, participants will have a baseline assessment including clinical tests,&#xD;
      MVC, the individuation task, and the configuration task. Following the baseline assessment&#xD;
      patients will receive intervention, training on the configuration task for 5 consecutive&#xD;
      days. On the sixth day and as a one week follow-up after, subjects will have a&#xD;
      post-intervention assessment containing the same tests performed in baseline.&#xD;
&#xD;
      This design will allow us to determine speed and accuracy during the configuration task, the&#xD;
      individuation index, and possible changes in abnormal flexion synergy.&#xD;
&#xD;
      We initially registered the study as two arms (anodal tDCS and sham tDCS groups) but decided&#xD;
      to make it one arm due to the number of participants we were able to recruit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Individuation Index</measure>
    <time_frame>Change from Baseline Individuation Index at 2 weeks</time_frame>
    <description>The relationship between forces (in Newton) in active vs passive fingers during a set of isolated finger movements. It is a measure of finger independence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>Change from Baseline ARAT at 2 weeks</time_frame>
    <description>Assesses upper limb functioning in activities of daily living using observational methods. It is a 19 item measure divided into a 4-point ordinal scale ranging from:&#xD;
3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty&#xD;
1: Performs test partially 0: Can perform no part of test.&#xD;
Possible score range of 0 to 57; higher scores equal less impairment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer (Motor Function - Upper Extremity Subscale)</measure>
    <time_frame>Change from Baseline Impairment Index at 2 weeks</time_frame>
    <description>Assesses functional mobility using observational methods. It is a 66 item measure. Its items are scored on a 3-point ordinal scale.&#xD;
0: Cannot perform&#xD;
performs partially&#xD;
performs fully&#xD;
Possible score range from 0 - 66</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy (Euclidian norm)</measure>
    <time_frame>Change from Baseline Accuracy at 2 weeks</time_frame>
    <description>The deviation of each finger from a target amount of force generation during a set of finger movements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Execution Time</measure>
    <time_frame>Change from Baseline Execution Time at 2 weeks</time_frame>
    <description>The time period from cue appearance to the first moment when finger forces reach the required target. Lower values equal faster execution time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semmes Weinstein Monofilament Examination (SWME)</measure>
    <time_frame>Change from Baseline SWME at 2 weeks</time_frame>
    <description>A quantitative method to systematically assess the threshold stimulus necessary for perception of light touch to deep pressure by using monofilaments of different sizes.&#xD;
Interpretation scale for monofilaments:&#xD;
2.83 Normal 3.61 Diminished light touch 4.31 Diminished protective sensation 4.56 Loss of protective sensation 6.65 Deep pressure sensation only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth scale</measure>
    <time_frame>Change from Baseline Modified Ashworth Scale at 2 weeks</time_frame>
    <description>Tests resistance to passive movement about a joint with varying degrees of velocity in order to assess muscle spasticity.&#xD;
Scoring:&#xD;
0 No increase in muscle tone&#xD;
1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension.&#xD;
1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range of motion (ROM).&#xD;
2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.&#xD;
3 Considerable increase in muscle tone, passive movement difficult.&#xD;
4 Affected part(s) rigid in flexion or extension</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cerebral Stroke</condition>
  <arm_group>
    <arm_group_label>Finger Dexterity Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic stroke patients (i.e. great than 6 months) with ischemic stroke confirmed by CT or MRI, residual unilateral upper extremity weakness, able to give informed consent, and able to understand the tasks involved.&#xD;
Participants trained for 5 consecutive days, 3 to 4 h/d, on a multi-finger piano-chord-like task that cannot be performed by compensatory actions of other body parts (e.g., arm). Participants had to learn to simultaneously coordinate and synchronize multiple fingers to break unwanted flexor synergies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Configuration task</intervention_name>
    <description>Training the impaired hand on a configuration task</description>
    <arm_group_label>Finger Dexterity Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 and older&#xD;
&#xD;
          -  Ischemic stroke greater than six months ago, confirmed by CT or MRI&#xD;
&#xD;
          -  Residuals unilateral upper extremity weakness&#xD;
&#xD;
          -  Ability to give informed consent and understand the tasks involved.&#xD;
&#xD;
          -  Appearance of Flexion synergy in hand.&#xD;
&#xD;
          -  Ability to extent finger at least for 5 degrees.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment, with score on Montreal Cognitive assessment (MoCA) ≤ 20&#xD;
&#xD;
          -  History of physical or neurological condition that interferes with study procedures or&#xD;
             assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's&#xD;
             disease)&#xD;
&#xD;
          -  Contraindication to tDCS (deep brain stimulators or other metal in the head, skull&#xD;
             defect, pacemaker)&#xD;
&#xD;
          -  Inability to sit in a chair and perform upper limb exercises for one hour at a time&#xD;
&#xD;
          -  Participation in another upper extremity rehabilitative therapy study or tDCS study&#xD;
             during the study period&#xD;
&#xD;
          -  Terminal illness&#xD;
&#xD;
          -  Social and/or personal circumstances that interfere with ability to return for therapy&#xD;
             sessions and follow up assessments&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe Neglect&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pablo Celnik</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical Medicine and Rehabilitation Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kennedy Krieger Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>May 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>November 1, 2021</last_update_submitted>
  <last_update_submitted_qc>November 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>motor recovery</keyword>
  <keyword>motor learning</keyword>
  <keyword>ischemic Stroke</keyword>
  <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/NCT03255590
org study id: NA_00082367
secondary id: 2R01HD053793-09A1
nct id: NCT03255590
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This study plans to determine whether training can change abnormal flexion synergy in chronic
      stroke patients.
The aim of the current study is to investigate whether motor training in chronic stroke
      patients can change their abnormal flexion synergy. The investigators will study chronic
      stroke patients , who are defined as patients that sustained a stroke at least 6 months prior
      to our testing date.

      Three functional aspects of each finger will be tested: maximal voluntary contraction (MVC),
      finger dexterity, and hand posture.

      Prior to intervention, participants will have a baseline assessment including clinical tests,
      MVC, the individuation task, and the configuration task. Following the baseline assessment
      patients will receive intervention, training on the configuration task for 5 consecutive
      days. On the sixth day and as a one week follow-up after, subjects will have a
      post-intervention assessment containing the same tests performed in baseline.

      This design will allow us to determine speed and accuracy during the configuration task, the
      individuation index, and possible changes in abnormal flexion synergy.

      We initially registered the study as two arms (anodal tDCS and sham tDCS groups) but decided
      to make it one arm due to the number of participants we were able to recruit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Individuation Index
time frame: Change from Baseline Individuation Index at 2 weeks
description: The relationship between forces (in Newton) in active vs passive fingers during a set of isolated finger movements. It is a measure of finger independence.
measure: Action Research Arm Test (ARAT)
time frame: Change from Baseline ARAT at 2 weeks
description: Assesses upper limb functioning in activities of daily living using observational methods. It is a 19 item measure divided into a 4-point ordinal scale ranging from:
3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty
1: Performs test partially 0: Can perform no part of test.
Possible score range of 0 to 57; higher scores equal less impairment.
measure: Fugl-Meyer (Motor Function - Upper Extremity Subscale)
time frame: Change from Baseline Impairment Index at 2 weeks
description: Assesses functional mobility using observational methods. It is a 66 item measure. Its items are scored on a 3-point ordinal scale.
0: Cannot perform
performs partially
performs fully
Possible score range from 0 - 66
measure: Accuracy (Euclidian norm)
time frame: Change from Baseline Accuracy at 2 weeks
description: The deviation of each finger from a target amount of force generation during a set of finger movements.
measure: Execution Time
time frame: Change from Baseline Execution Time at 2 weeks
description: The time period from cue appearance to the first moment when finger forces reach the required target. Lower values equal faster execution time.
measure: Semmes Weinstein Monofilament Examination (SWME)
time frame: Change from Baseline SWME at 2 weeks
description: A quantitative method to systematically assess the threshold stimulus necessary for perception of light touch to deep pressure by using monofilaments of different sizes.
Interpretation scale for monofilaments:
2.83 Normal 3.61 Diminished light touch 4.31 Diminished protective sensation 4.56 Loss of protective sensation 6.65 Deep pressure sensation only
measure: Modified Ashworth scale
time frame: Change from Baseline Modified Ashworth Scale at 2 weeks
description: Tests resistance to passive movement about a joint with varying degrees of velocity in order to assess muscle spasticity.
Scoring:
0 No increase in muscle tone
1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension.
1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range of motion (ROM).
2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.
3 Considerable increase in muscle tone, passive movement difficult.
4 Affected part(s) rigid in flexion or extension
arm group label: Finger Dexterity Training
arm group type: Experimental
description: Chronic stroke patients (i.e. great than 6 months) with ischemic stroke confirmed by CT or MRI, residual unilateral upper extremity weakness, able to give informed consent, and able to understand the tasks involved.
Participants trained for 5 consecutive days, 3 to 4 h/d, on a multi-finger piano-chord-like task that cannot be performed by compensatory actions of other body parts (e.g., arm). Participants had to learn to simultaneously coordinate and synchronize multiple fingers to break unwanted flexor synergies.
intervention type: Behavioral
intervention name: Configuration task
description: Training the impaired hand on a configuration task
arm group label: Finger Dexterity Training
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: No
last name: Pablo Celnik
role: Principal Investigator
affiliation: Department of Physical Medicine and Rehabilitation Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No