<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/NCT03271463</url>
  </required_header>
  <id_info>
    <org_study_id>PMR-2017-25802</org_study_id>
    <nct_id>NCT03271463</nct_id>
  </id_info>
  <brief_title>Assessing Leg Control in People With Chronic Stroke</brief_title>
  <official_title>Lower Extremity Selective Voluntary Motor Control in Adults With Chronic Stroke: Comparing the SCALE Assessment to the Fugl-Meyer Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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>
      The purpose of this study is to compare the clinometric (psychometric) properties of the&#xD;
      SCALE and FMA-LE assessments in adults after stroke. A second purpose is to determine how&#xD;
      well each measure predicts walking speed using the 10 meter walk test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Selective voluntary motor control may be important in prognosticating future function in&#xD;
      adults post stroke. It is therefore important to measure selective voluntary motor control&#xD;
      using assessments that are valid, reliable and easy to perform and interpret. Current&#xD;
      assessments are time consuming and complicated. Clinicians who work with patients post stroke&#xD;
      will benefit from this research because they will have evidence supporting appropriate&#xD;
      measurement of selective voluntary motor control. This evidence may inform their clinical&#xD;
      decision making when working with patients. Patients who have survived a stroke will benefit&#xD;
      because their therapists will be able to better measure their selective voluntary motor&#xD;
      control which may one day lead to better prediction of functional outcomes and the selection&#xD;
      of appropriate interventions.&#xD;
&#xD;
      The Fugl-Meyer assessment (FMA) is the &quot;Gold Standard&quot; for the assessment of individuals with&#xD;
      brain injury, most commonly those surviving cerebrovascular accident (stroke). The full&#xD;
      assessment is complicated and can take more than an hour to complete. Clinicians have limited&#xD;
      time to perform a full evaluation of their patients, the FMA is just one part of this&#xD;
      evaluation. The lower extremity selective voluntary motor control component of the FMA&#xD;
      (FMA-LE) is difficult for clinicians who are not experts to perform and interpret. For these&#xD;
      reasons, few practicing clinicians use the FMA. However, measuring selective voluntary motor&#xD;
      control may be important for prognosticating patients' future functional level and their need&#xD;
      for continued therapeutic interventions. The Selective Control Assessment of Lower Extremity&#xD;
      (SCALE) was developed for use with children who have cerebral palsy (CP), a condition that in&#xD;
      some ways presents similar to stroke. The SCALE has been validated and deemed reliable in the&#xD;
      pediatric population with CP. This study aims to determine inter-rater and intra-rater&#xD;
      reliability for the FMA-LE and the SCALE. In addition, scores on the SCALE will be compared&#xD;
      to scores on the FMA-LE to determine concurrent validity. Finally the scores on the SCALE and&#xD;
      FMA-LE will be compared to the time it takes for stroke survivors to walk 10-meters (10-meter&#xD;
      walk test) to determine how well each measure predicts functional status (predictive&#xD;
      validity).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2018</start_date>
  <completion_date type="Actual">November 5, 2020</completion_date>
  <primary_completion_date type="Actual">November 5, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Selective Control Assessment of Lower Extremity (SCALE)</measure>
    <time_frame>Baseline to 4 weeks</time_frame>
    <description>Each item is rated 2-0, 2 being Normal and 0 being Unable to Move</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment-Lower Extremity component (FMA-LE)</measure>
    <time_frame>Baseline to 4 weeks</time_frame>
    <description>The complete Fugl-Meyer contains 155 items and each item is rated on a three-point ordinal scale, 2 points for the detail being performed completely, 1 point for the detail being partially completed, and 0 points for the detail not being performed. The maximum score for the motor performance is divided into 66 points for the upper extremity and 34 for the lower extremity. Only the lower extremity motor assessment component of the Fugl-Meyer will be used for this study, which consists of 17 items.&#xD;
Fugl-Meyer Assessment (Upper and lower extremity components). Available from: https://www.researchgate.net/publ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10-meter walk test</measure>
    <time_frame>Baseline to 4 weeks</time_frame>
    <description>Performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. Scoring is done by completing three trials and calculating the average of the three trials to obtain the velocity. The test may be completed at the subject's self-selected velocity and/or at the subject's fast velocity.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Chronic Stroke</condition>
  <arm_group>
    <arm_group_label>Reliability/Validity of SCALE Assessment</arm_group_label>
    <description>Reliability + validity of the Selective Control Assessment of Lower Extremity (SCALE) in people with chronic stroke.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Selective Control Assessment of Lower Extremity (SCALE)</intervention_name>
    <description>Inter- and intra-rater reliability Validity: correlation analysis with Fugl-Meyer Assessment - Lower Extremity Component (FMA-LE) and 10 meter walk test (see below)</description>
    <arm_group_label>Reliability/Validity of SCALE Assessment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with chronic stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between 18 and 79 years of age who have sustained a chronic cerebrovascular&#xD;
             accident (stroke) with known corticospinal tract damage&#xD;
&#xD;
          -  At least one year after onset&#xD;
&#xD;
          -  Ability to walk&#xD;
&#xD;
          -  Ability to understand and follow simple instructions&#xD;
&#xD;
          -  Written informed consent obtained from subject&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cerebellar infarct, traumatic brain injury, tumor, etc.&#xD;
&#xD;
          -  Rigidity, ataxia, or other Cerebellar or Basal Ganglia signs or symptoms.&#xD;
&#xD;
          -  Hospitalizations in the past 6 months.&#xD;
&#xD;
          -  Neurosurgical or Musculoskeletal surgery in last 12 months.&#xD;
&#xD;
          -  Neurological or Musculoskeletal injury within the past month.&#xD;
&#xD;
          -  Pain that interferes with the ability to assume side-lying position.&#xD;
&#xD;
          -  Medication for hypertonicity: Participants may be on medicine for abnormal tone.&#xD;
&#xD;
        However, there must not be any of the following:&#xD;
&#xD;
          1. Change in dosage or type of medication during the past 6 months&#xD;
&#xD;
          2. Botox injection(s) within 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah Diaz, PT,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mary Baldwin University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Teresa A Bisson, PT,DPT,NCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.</citation>
    <PMID>1135616</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>April 13, 2021</last_update_submitted>
  <last_update_submitted_qc>April 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>selective voluntary motor control</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>
    <ipd_description>There is not a plan to make IPD available.</ipd_description>
  </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/NCT03271463
org study id: PMR-2017-25802
nct id: NCT03271463
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the clinometric (psychometric) properties of the
      SCALE and FMA-LE assessments in adults after stroke. A second purpose is to determine how
      well each measure predicts walking speed using the 10 meter walk test.
Selective voluntary motor control may be important in prognosticating future function in
      adults post stroke. It is therefore important to measure selective voluntary motor control
      using assessments that are valid, reliable and easy to perform and interpret. Current
      assessments are time consuming and complicated. Clinicians who work with patients post stroke
      will benefit from this research because they will have evidence supporting appropriate
      measurement of selective voluntary motor control. This evidence may inform their clinical
      decision making when working with patients. Patients who have survived a stroke will benefit
      because their therapists will be able to better measure their selective voluntary motor
      control which may one day lead to better prediction of functional outcomes and the selection
      of appropriate interventions.

      The Fugl-Meyer assessment (FMA) is the "Gold Standard" for the assessment of individuals with
      brain injury, most commonly those surviving cerebrovascular accident (stroke). The full
      assessment is complicated and can take more than an hour to complete. Clinicians have limited
      time to perform a full evaluation of their patients, the FMA is just one part of this
      evaluation. The lower extremity selective voluntary motor control component of the FMA
      (FMA-LE) is difficult for clinicians who are not experts to perform and interpret. For these
      reasons, few practicing clinicians use the FMA. However, measuring selective voluntary motor
      control may be important for prognosticating patients' future functional level and their need
      for continued therapeutic interventions. The Selective Control Assessment of Lower Extremity
      (SCALE) was developed for use with children who have cerebral palsy (CP), a condition that in
      some ways presents similar to stroke. The SCALE has been validated and deemed reliable in the
      pediatric population with CP. This study aims to determine inter-rater and intra-rater
      reliability for the FMA-LE and the SCALE. In addition, scores on the SCALE will be compared
      to scores on the FMA-LE to determine concurrent validity. Finally the scores on the SCALE and
      FMA-LE will be compared to the time it takes for stroke survivors to walk 10-meters (10-meter
      walk test) to determine how well each measure predicts functional status (predictive
      validity).
observational model: Cohort
time perspective: Prospective
measure: Selective Control Assessment of Lower Extremity (SCALE)
time frame: Baseline to 4 weeks
description: Each item is rated 2-0, 2 being Normal and 0 being Unable to Move
measure: Fugl-Meyer Assessment-Lower Extremity component (FMA-LE)
time frame: Baseline to 4 weeks
description: The complete Fugl-Meyer contains 155 items and each item is rated on a three-point ordinal scale, 2 points for the detail being performed completely, 1 point for the detail being partially completed, and 0 points for the detail not being performed. The maximum score for the motor performance is divided into 66 points for the upper extremity and 34 for the lower extremity. Only the lower extremity motor assessment component of the Fugl-Meyer will be used for this study, which consists of 17 items.
Fugl-Meyer Assessment (Upper and lower extremity components). Available from: https://www.researchgate.net/publ
measure: 10-meter walk test
time frame: Baseline to 4 weeks
description: Performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. Scoring is done by completing three trials and calculating the average of the three trials to obtain the velocity. The test may be completed at the subject's self-selected velocity and/or at the subject's fast velocity.
arm group label: Reliability/Validity of SCALE Assessment
description: Reliability + validity of the Selective Control Assessment of Lower Extremity (SCALE) in people with chronic stroke.
intervention type: Behavioral
intervention name: Selective Control Assessment of Lower Extremity (SCALE)
description: Inter- and intra-rater reliability Validity: correlation analysis with Fugl-Meyer Assessment - Lower Extremity Component (FMA-LE) and 10 meter walk test (see below)
arm group label: Reliability/Validity of SCALE Assessment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Deborah Diaz, PT,PhD
role: Principal Investigator
affiliation: Mary Baldwin University
last name: Teresa A Bisson, PT,DPT,NCS
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
citation: Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PMID: 1135616
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No
ipd description: There is not a plan to make IPD available.