<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/NCT03803566</url>
  </required_header>
  <id_info>
    <org_study_id>18-0269</org_study_id>
    <nct_id>NCT03803566</nct_id>
  </id_info>
  <brief_title>Age-independent Decline in Manual Dexterity of Middle-aged and Older Adults</brief_title>
  <official_title>Age-independent Decline in Manual Dexterity of Middle-aged and Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Boulder</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Boulder</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 objective of the clinical trial is to evaluate the mediating influence of force control&#xD;
      on the pegboard times of adults (50-89 years) who are stratified into groups of faster and&#xD;
      slower pegboard times. The hypothesis is that practice of either a pegboard test or a&#xD;
      force-control task will reduce pegboard times, but the decrease will be greater and less&#xD;
      similar after the two practice interventions for the slower group of participants. The&#xD;
      outcomes are expected to demonstrate that force control is a modifiable mediator of pegboard&#xD;
      times for this cohort, but the effect will be stronger for the group with faster pegboard&#xD;
      times.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will involve a randomized, cross-over design with a one-week washout between arms.&#xD;
      The two arms (3 weeks each) will comprise practice of the grooved pegboard test and practice&#xD;
      of steady contractions while lifting and lowering light loads with a hand muscle.&#xD;
      Randomization into practice order will be accomplished with a block approach (block size = 4)&#xD;
      for each of the two groups. The outcome assessors will be blinded to practice order. The&#xD;
      outcomes will comprise three tests of manual dexterity and the measurement of force control&#xD;
      during submaximal contractions. The outcomes will be obtained before and after the six&#xD;
      sessions in each practice arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The grant application has not been approved&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 2025</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Anticipated">November 2025</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Grooved pegboard test</measure>
    <time_frame>Changes from baseline (week 1) at weeks 4 and 7</time_frame>
    <description>Time to complete the test as quickly as possible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>9-hole pegboard test</measure>
    <time_frame>Changes from baseline (week 1) at weeks 4 and 7</time_frame>
    <description>Time to complete the test as quickly as possible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Jebsen Hand Function test</measure>
    <time_frame>Changes from baseline (week 1) at weeks 4 and 7</time_frame>
    <description>Time to complete the test as quickly as possible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Force control</measure>
    <time_frame>Changes from baseline (week 1) at weeks 4 and 7</time_frame>
    <description>The coefficient of variation for force when subjects exert a constant submaximal force</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EMG amplitude</measure>
    <time_frame>Changes from baseline (week 1) at weeks 4 and 7</time_frame>
    <description>Absolute amplitude of the electromyographic (EMG) signal for the involved muscles during the steady contractions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MVC force</measure>
    <time_frame>Changes from baseline (week 1) at weeks 4 and 7</time_frame>
    <description>The peak force exerted during a maximal isometric contractions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-RM load</measure>
    <time_frame>Changes from baseline (week 1) at weeks 4 and 7</time_frame>
    <description>The maximal weight that can be lifted once</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Index finger acceleration</measure>
    <time_frame>Changes from baseline (week 1) at weeks 4 and 7</time_frame>
    <description>The average standard deviation of index finger acceleration in the abduction-adduction plane when a light load is being lifted and lowered during the practice intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor unit discharge rates</measure>
    <time_frame>Changes from baseline (week 1) at weeks 4 and 7</time_frame>
    <description>The discharge times of action potentials by motor units during the steady submaximal contractions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Faster</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will comprise participants who complete the grooved pegboard test at baseline with a time of less than 71 seconds. One half of the members in this group will perform the two interventions in the order of pegboard practice and then force control practice, whereas the other half of the group will perform the two practice interventions in the opposite order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Slower</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will comprise participants who complete the grooved pegboard test at baseline with a time of greater than 70 seconds. One half of the members in this group will perform the two interventions in the order of pegboard practice and then force control practice, whereas the other half of the group will perform the two practice interventions in the opposite order.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pegboard practice</intervention_name>
    <description>Practice of the grooved pegboard test</description>
    <arm_group_label>Faster</arm_group_label>
    <arm_group_label>Slower</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Force control practice</intervention_name>
    <description>Practice performing steady muscle contractions</description>
    <arm_group_label>Faster</arm_group_label>
    <arm_group_label>Slower</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to read, write, and speak English&#xD;
&#xD;
          -  Able to arrange transportation to the Boulder campus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Major psychiatric condition&#xD;
&#xD;
          -  Unstable depressive disorder&#xD;
&#xD;
          -  Progressive neurological, muscular, cardiovascular, or skeletal disorder&#xD;
&#xD;
          -  Chronic pain condition&#xD;
&#xD;
          -  Currently taking medication known to influence neuromuscular function&#xD;
&#xD;
          -  Recent hospitalization&#xD;
&#xD;
          -  Unable to attend 12 practice sessions in 6 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roger Enoka, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Boulder</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Boulder</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80309</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>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>November 12, 2021</last_update_submitted>
  <last_update_submitted_qc>November 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Colorado, Boulder</investigator_affiliation>
    <investigator_full_name>Roger Enoka</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Manual dexterity</keyword>
  <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/NCT03803566
org study id: 18-0269
nct id: NCT03803566
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the clinical trial is to evaluate the mediating influence of force control
      on the pegboard times of adults (50-89 years) who are stratified into groups of faster and
      slower pegboard times. The hypothesis is that practice of either a pegboard test or a
      force-control task will reduce pegboard times, but the decrease will be greater and less
      similar after the two practice interventions for the slower group of participants. The
      outcomes are expected to demonstrate that force control is a modifiable mediator of pegboard
      times for this cohort, but the effect will be stronger for the group with faster pegboard
      times.
The study will involve a randomized, cross-over design with a one-week washout between arms.
      The two arms (3 weeks each) will comprise practice of the grooved pegboard test and practice
      of steady contractions while lifting and lowering light loads with a hand muscle.
      Randomization into practice order will be accomplished with a block approach (block size = 4)
      for each of the two groups. The outcome assessors will be blinded to practice order. The
      outcomes will comprise three tests of manual dexterity and the measurement of force control
      during submaximal contractions. The outcomes will be obtained before and after the six
      sessions in each practice arm.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Grooved pegboard test
time frame: Changes from baseline (week 1) at weeks 4 and 7
description: Time to complete the test as quickly as possible
measure: 9-hole pegboard test
time frame: Changes from baseline (week 1) at weeks 4 and 7
description: Time to complete the test as quickly as possible
measure: Jebsen Hand Function test
time frame: Changes from baseline (week 1) at weeks 4 and 7
description: Time to complete the test as quickly as possible
measure: Force control
time frame: Changes from baseline (week 1) at weeks 4 and 7
description: The coefficient of variation for force when subjects exert a constant submaximal force
measure: EMG amplitude
time frame: Changes from baseline (week 1) at weeks 4 and 7
description: Absolute amplitude of the electromyographic (EMG) signal for the involved muscles during the steady contractions
measure: MVC force
time frame: Changes from baseline (week 1) at weeks 4 and 7
description: The peak force exerted during a maximal isometric contractions
measure: 1-RM load
time frame: Changes from baseline (week 1) at weeks 4 and 7
description: The maximal weight that can be lifted once
measure: Index finger acceleration
time frame: Changes from baseline (week 1) at weeks 4 and 7
description: The average standard deviation of index finger acceleration in the abduction-adduction plane when a light load is being lifted and lowered during the practice intervention
measure: Motor unit discharge rates
time frame: Changes from baseline (week 1) at weeks 4 and 7
description: The discharge times of action potentials by motor units during the steady submaximal contractions
arm group label: Faster
arm group type: Experimental
description: This group will comprise participants who complete the grooved pegboard test at baseline with a time of less than 71 seconds. One half of the members in this group will perform the two interventions in the order of pegboard practice and then force control practice, whereas the other half of the group will perform the two practice interventions in the opposite order.
arm group label: Slower
arm group type: Experimental
description: This group will comprise participants who complete the grooved pegboard test at baseline with a time of greater than 70 seconds. One half of the members in this group will perform the two interventions in the order of pegboard practice and then force control practice, whereas the other half of the group will perform the two practice interventions in the opposite order.
intervention type: Other
intervention name: Pegboard practice
description: Practice of the grooved pegboard test
arm group label: Faster
arm group label: Slower
intervention type: Other
intervention name: Force control practice
description: Practice performing steady muscle contractions
arm group label: Faster
arm group label: Slower
criteria: 
gender: All
minimum age: 50 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roger Enoka, PhD
role: Principal Investigator
affiliation: University of Colorado, Boulder
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Colorado, Boulder
investigator full name: Roger Enoka
investigator title: Professor
sharing ipd: No