<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/NCT02998021</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16010169</org_study_id>
    <nct_id>NCT02998021</nct_id>
  </id_info>
  <brief_title>Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain</brief_title>
  <official_title>Effect of Vibration Exercise on Upper Limb Strength, Function, and Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alicia Koontz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to explore the benefits of vibration dumbbell resistance&#xD;
      training over standard dumbbell resistance training for improving upper limb strength,&#xD;
      function and pain among manual wheelchair users with paraplegia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: The primary purpose of this study is to explore the benefits of vibration&#xD;
      dumbbell resistance training over standard dumbbell resistance training for improving upper&#xD;
      limb strength, function and pain among manual wheelchair users with paraplegia.&#xD;
&#xD;
      Experimental Design: Design: Randomized Control Trial&#xD;
&#xD;
      Methods: Twenty subjects with paraplegia will be recruited and randomized into two groups, a&#xD;
      vibration dumbbell training (V-DT) group and a standard dumbbell training group (S-DT). Both&#xD;
      groups will participate in a supervised 12-week (3 sessions per week) dumbbell (free-weight)&#xD;
      strength training program consisting of nine exercises specifically designed to improve upper&#xD;
      limb muscle function to support propulsion and transfer activities and protect the shoulders&#xD;
      from developing pain. For each of the nine exercises the vibration group will hold a&#xD;
      high-frequency (40 Hz) vibrating dumbbell in a static arm posture (isometric training) while&#xD;
      the control group will move a non-vibrating dumbbell through the full range of motion for a&#xD;
      given exercise (isotonic training). Both groups will follow a standardized protocol for&#xD;
      assessing and progressing the amount of weight that is added to the dumbbell to achieve&#xD;
      optimal training effects.&#xD;
&#xD;
      All participants will participate in laboratory testing for various outcome measures at&#xD;
      baseline, 6 weeks and 12 weeks .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">November 20, 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Strength</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Upper Extremity Pain</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in General Health Measures</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Functional Shoulder Pain</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Speed</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Acceleration</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change in acceleration (seconds) during the 250 foot level propulsion task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Force</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mechanical Effective Force</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wheelchair Transfer Ability</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Power Output</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Measurement of peak power output (watts/kg) using the Load Arm Ergometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Resistance Training - Vibrating Dumbbell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance Training - Standard Dumbbell</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibrating Dumbbell</intervention_name>
    <description>Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
    <arm_group_label>Resistance Training - Vibrating Dumbbell</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Dumbbell</intervention_name>
    <description>Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the Institutional Review Board (IRB) to cease enrolling subjects into standard dumbbell training.</description>
    <arm_group_label>Resistance Training - Standard Dumbbell</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have a neurological impairment secondary to spinal cord injury (SCI) or disease at T2&#xD;
             or lower&#xD;
&#xD;
          -  greater than 6 months post injury&#xD;
&#xD;
          -  use a manual wheelchair as primary means of mobility (at least 30 hrs. per week)&#xD;
&#xD;
          -  18 to 65 years of age&#xD;
&#xD;
          -  provide signed medical release by primary care physician to engage in a high-intensity&#xD;
             resistance training exercise program&#xD;
&#xD;
          -  live within 60 minutes driving time (1 hour) from the research center&#xD;
&#xD;
          -  able to perform a transfer independently to and from a wheelchair&#xD;
&#xD;
          -  have normal range of motion in the upper limbs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of fractures or dislocations in the shoulder, elbow and wrist from which the&#xD;
             subject has not fully recovered or joint replacement of any of the joints in the upper&#xD;
             extremities&#xD;
&#xD;
          -  upper limb pain that interferes with the ability to propel or transfer&#xD;
&#xD;
          -  recent hospitalization for any reason (within the past three months)&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  history of coronary artery disease, coronary bypass surgery or other&#xD;
             cardio-respiratory events&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alicia Koontz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>November 20, 2019</results_first_submitted>
  <results_first_submitted_qc>December 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 23, 2019</results_first_posted>
  <last_update_submitted>December 19, 2019</last_update_submitted>
  <last_update_submitted_qc>December 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Alicia Koontz</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT02998021/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Resistance Training - Vibrating Dumbbell</title>
          <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
        </group>
        <group group_id="P2">
          <title>Resistance Training - Standard Dumbbell</title>
          <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>unsafe home</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Resistance Training - Vibrating Dumbbell</title>
          <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
        </group>
        <group group_id="B2">
          <title>Resistance Training - Standard Dumbbell</title>
          <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.6" spread="9.9"/>
                    <measurement group_id="B2" value="41.4" spread="3.5"/>
                    <measurement group_id="B3" value="46.4" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Strength</title>
        <description>Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit. There were technical problems with collected the strength data for one subject in the intervention group.</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Strength</title>
          <description>Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.</description>
          <population>Subjects in the control group withdrew before the 12 week visit. There were technical problems with collected the strength data for one subject in the intervention group.</population>
          <units>Nm/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Upper Extremity Pain</title>
        <description>Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Upper Extremity Pain</title>
          <description>Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain.</description>
          <population>Subjects in the control group withdrew before the 12 week visit</population>
          <units>units on the scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-1" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in General Health Measures</title>
        <description>Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in General Health Measures</title>
          <description>Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state.</description>
          <population>Subjects in the control group withdrew before the 12 week visit</population>
          <units>units on the scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Functional Shoulder Pain</title>
        <description>Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Functional Shoulder Pain</title>
          <description>Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain.</description>
          <population>Subjects in the control group withdrew before the 12 week visit</population>
          <units>units on the scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Peak Speed</title>
        <description>Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit. There were technical issues that prevented SmartWheel data collection for 3 subjects in the intervention group.</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Speed</title>
          <description>Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.</description>
          <population>Subjects in the control group withdrew before the 12 week visit. There were technical issues that prevented SmartWheel data collection for 3 subjects in the intervention group.</population>
          <units>meters/second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Acceleration</title>
        <description>Change in acceleration (seconds) during the 250 foot level propulsion task.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Acceleration</title>
          <description>Change in acceleration (seconds) during the 250 foot level propulsion task.</description>
          <population>Subjects in the control group withdrew before the 12 week visit</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Peak Force</title>
        <description>Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit. There were technical issues preventing the SmartWheel data collection for 3 subjects in the intervention group</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Force</title>
          <description>Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.</description>
          <population>Subjects in the control group withdrew before the 12 week visit. There were technical issues preventing the SmartWheel data collection for 3 subjects in the intervention group</population>
          <units>Newtons</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mechanical Effective Force</title>
        <description>Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit. There were technical issues prevention SmartWheel data collection for 3 subjects in the intervention group.</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mechanical Effective Force</title>
          <description>Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel.</description>
          <population>Subjects in the control group withdrew before the 12 week visit. There were technical issues prevention SmartWheel data collection for 3 subjects in the intervention group.</population>
          <units>unitless</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wheelchair Transfer Ability</title>
        <description>Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Wheelchair Transfer Ability</title>
          <description>Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).</description>
          <population>Subjects in the control group withdrew before the 12 week visit</population>
          <units>inches</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="-2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Power Output</title>
        <description>Measurement of peak power output (watts/kg) using the Load Arm Ergometer.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Subjects in the control group withdrew before the 12 week visit</population>
        <group_list>
          <group group_id="O1">
            <title>Resistance Training - Vibrating Dumbbell</title>
            <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
          </group>
          <group group_id="O2">
            <title>Resistance Training - Standard Dumbbell</title>
            <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
          </group>
        </group_list>
        <measure>
          <title>Power Output</title>
          <description>Measurement of peak power output (watts/kg) using the Load Arm Ergometer.</description>
          <population>Subjects in the control group withdrew before the 12 week visit</population>
          <units>Watts/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year, 9 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Resistance Training - Vibrating Dumbbell</title>
          <description>Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.&#xD;
Vibrating Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.</description>
        </group>
        <group group_id="E2">
          <title>Resistance Training - Standard Dumbbell</title>
          <description>Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.&#xD;
Standard Dumbbell: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.&#xD;
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.&#xD;
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the IRB to cease enrolling subjects into standard dumbbell training.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Alicia Koontz, PhD</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>4128223700</phone>
      <email>akoontz@pitt.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02998021
org study id: PRO16010169
nct id: NCT02998021
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The primary purpose of this study is to explore the benefits of vibration dumbbell resistance
      training over standard dumbbell resistance training for improving upper limb strength,
      function and pain among manual wheelchair users with paraplegia.
Objectives: The primary purpose of this study is to explore the benefits of vibration
      dumbbell resistance training over standard dumbbell resistance training for improving upper
      limb strength, function and pain among manual wheelchair users with paraplegia.

      Experimental Design: Design: Randomized Control Trial

      Methods: Twenty subjects with paraplegia will be recruited and randomized into two groups, a
      vibration dumbbell training (V-DT) group and a standard dumbbell training group (S-DT). Both
      groups will participate in a supervised 12-week (3 sessions per week) dumbbell (free-weight)
      strength training program consisting of nine exercises specifically designed to improve upper
      limb muscle function to support propulsion and transfer activities and protect the shoulders
      from developing pain. For each of the nine exercises the vibration group will hold a
      high-frequency (40 Hz) vibrating dumbbell in a static arm posture (isometric training) while
      the control group will move a non-vibrating dumbbell through the full range of motion for a
      given exercise (isotonic training). Both groups will follow a standardized protocol for
      assessing and progressing the amount of weight that is added to the dumbbell to achieve
      optimal training effects.

      All participants will participate in laboratory testing for various outcome measures at
      baseline, 6 weeks and 12 weeks .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Strength
time frame: Baseline and 12 weeks
description: Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.
measure: Change in Upper Extremity Pain
time frame: Baseline and 12 weeks
description: Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain.
measure: Change in General Health Measures
time frame: Baseline and 12 weeks
description: Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state.
measure: Changes in Functional Shoulder Pain
time frame: Baseline and 12 weeks
description: Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain.
measure: Change in Peak Speed
time frame: Baseline and 12 weeks
description: Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.
measure: Change in Acceleration
time frame: Baseline and 12 weeks
description: Change in acceleration (seconds) during the 250 foot level propulsion task.
measure: Change in Peak Force
time frame: Baseline and 12 weeks
description: Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.
measure: Change in Mechanical Effective Force
time frame: Baseline and 12 weeks
description: Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel.
measure: Wheelchair Transfer Ability
time frame: Baseline and 12 weeks
description: Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).
measure: Power Output
time frame: Baseline and 12 weeks
description: Measurement of peak power output (watts/kg) using the Load Arm Ergometer.
arm group label: Resistance Training - Vibrating Dumbbell
arm group type: Experimental
description: Study participants who are randomized into the vibration exercise group will complete an in-home exercise program using a vibrating dumbbell.
arm group label: Resistance Training - Standard Dumbbell
arm group type: Active Comparator
description: Study participants who are randomized into the control exercise group will complete an in-home exercise program using standard dumbbells.
intervention type: Device
intervention name: Vibrating Dumbbell
description: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.
arm group label: Resistance Training - Vibrating Dumbbell
intervention type: Device
intervention name: Standard Dumbbell
description: Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.
The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.
To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the Institutional Review Board (IRB) to cease enrolling subjects into standard dumbbell training.
arm group label: Resistance Training - Standard Dumbbell
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Alicia Koontz, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Alicia Koontz
investigator title: Associate Professor
mesh term: Spinal Cord Injuries
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 