<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/NCT03289689</url>
  </required_header>
  <id_info>
    <org_study_id>URJC</org_study_id>
    <nct_id>NCT03289689</nct_id>
  </id_info>
  <brief_title>Whole-body Vibration and Manual Ability</brief_title>
  <official_title>The Acute Effects of Whole-Body Vibration on Manual Ability Performance: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Rey Juan Carlos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To evaluate the short-term effects of whole-body vibration (WBV), using&#xD;
      reciprocating plate technique, on manual ability performance in healthy younger.&#xD;
&#xD;
      Material and methods: 38 healthy young volunteers were randomized to WBV group (N=19; 6 men,&#xD;
      13 women; mean age 21, 3.8yrs) or control group (N=19; 6 men, 13 women; mean age 20.5,&#xD;
      3.5yrs). The subjects in the WBV group performed one series of five consecutive repetitions&#xD;
      of 60 sec unsynchronised WBV (Zeptoring, Scisen GmbH, Germany; 4 Hz, amplitude 3mm) with a&#xD;
      1-min pause between administrations, three times a week. The controls did not receive any&#xD;
      training. Both groups were evaluated at baseline and after intervention, in the Rey Juan&#xD;
      Carlos University´s Gait Analysis Laboratory. Four outcome measures of Purdue Pegboard test&#xD;
      (PPT): preferred hand (PH), non-preferred hand (NPH), both hands (BH) and assembly (A) was&#xD;
      performed baseline and 5 min after intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">September 10, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Purdue Pegboard test (change)</measure>
    <time_frame>Baseline, immediately after intervention and one month after the intervention</time_frame>
    <description>Change in Purdue Pegboard test. This tool evaluates the fine dexterity</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Body Weight</condition>
  <condition>Vibration</condition>
  <condition>Motor Activity</condition>
  <arm_group>
    <arm_group_label>Whole body vibration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects in the WBV group performed one series of five consecutive repetitions of 60 sec unsynchronised multidimensional WBV (Zeptoring, Scisen GmbH, Germany; 4 Hz, amplitude 3mm) with a 1-min pause between administrations, three times a week. The construction of this device is designed to perform a nonharmonious generation of oscillating movements in vertical and horizontal planes in order to prevent occurrences of resonance and habituation of receptors.&#xD;
During the intervention, subjects wore thin-soled gymnastic-type shoes, carrying out in a squatting standing position, with slight flexion at the hips, knees and ankle joint, on the vibration platform.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The controls did not receive any training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Whole-body vibration (WBV)</intervention_name>
    <description>Whole-body vibration (WBV) is a novel neuromuscular therapeutic intervention that has recently been developed since in the mid-1960s. Hagbart and Eklund showed in human experiments that a reflex muscle contraction can result as a consequence of applying vibrations to the muscular-tendon system. The subjects stand on a platform that generates stochastic vibrations at a frequency between 1-12.5 Hz.</description>
    <arm_group_label>Whole body vibration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Healthy subjects aged between 18 and 30 years.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Contraindication for WBV: pregnancy, recent fractures, malignancies, kidney stones,&#xD;
             cardiac pacemaker, infectious disease or recent thromboembolic.&#xD;
&#xD;
          -  Subjects with any musculoskeletal o neurological disorders that affected their hands.&#xD;
&#xD;
          -  Individuals already treated with WBV were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad Rey Juan Carlos</name>
      <address>
        <city>Alcorcón</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>November 26, 2017</last_update_submitted>
  <last_update_submitted_qc>November 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>Josue Fernandez Carnero</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03289689
org study id: URJC
nct id: NCT03289689
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose: To evaluate the short-term effects of whole-body vibration (WBV), using
      reciprocating plate technique, on manual ability performance in healthy younger.

      Material and methods: 38 healthy young volunteers were randomized to WBV group (N=19; 6 men,
      13 women; mean age 21, 3.8yrs) or control group (N=19; 6 men, 13 women; mean age 20.5,
      3.5yrs). The subjects in the WBV group performed one series of five consecutive repetitions
      of 60 sec unsynchronised WBV (Zeptoring, Scisen GmbH, Germany; 4 Hz, amplitude 3mm) with a
      1-min pause between administrations, three times a week. The controls did not receive any
      training. Both groups were evaluated at baseline and after intervention, in the Rey Juan
      Carlos University´s Gait Analysis Laboratory. Four outcome measures of Purdue Pegboard test
      (PPT): preferred hand (PH), non-preferred hand (NPH), both hands (BH) and assembly (A) was
      performed baseline and 5 min after intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Purdue Pegboard test (change)
time frame: Baseline, immediately after intervention and one month after the intervention
description: Change in Purdue Pegboard test. This tool evaluates the fine dexterity
arm group label: Whole body vibration
arm group type: Experimental
description: The subjects in the WBV group performed one series of five consecutive repetitions of 60 sec unsynchronised multidimensional WBV (Zeptoring, Scisen GmbH, Germany; 4 Hz, amplitude 3mm) with a 1-min pause between administrations, three times a week. The construction of this device is designed to perform a nonharmonious generation of oscillating movements in vertical and horizontal planes in order to prevent occurrences of resonance and habituation of receptors.
During the intervention, subjects wore thin-soled gymnastic-type shoes, carrying out in a squatting standing position, with slight flexion at the hips, knees and ankle joint, on the vibration platform.
arm group label: Control
arm group type: No Intervention
description: The controls did not receive any training.
intervention type: Device
intervention name: Whole-body vibration (WBV)
description: Whole-body vibration (WBV) is a novel neuromuscular therapeutic intervention that has recently been developed since in the mid-1960s. Hagbart and Eklund showed in human experiments that a reflex muscle contraction can result as a consequence of applying vibrations to the muscular-tendon system. The subjects stand on a platform that generates stochastic vibrations at a frequency between 1-12.5 Hz.
arm group label: Whole body vibration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: Josue Fernandez Carnero
investigator title: Principal Investigator
mesh term: Body Weight
sharing ipd: Undecided