<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/NCT02989831</url>
  </required_header>
  <id_info>
    <org_study_id>NL48517.042.14</org_study_id>
    <nct_id>NCT02989831</nct_id>
  </id_info>
  <brief_title>The Effect of Random Vibrations on Perception and Balance</brief_title>
  <official_title>The Effects of Random Vibrations on the Vibratory Perception Threshold of the Foot and Standing Balance in People With Diabetic Neuropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of vibrating insoles on vibration&#xD;
      perception threshold (VPT) and balance of people with diabetic neuropathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: People with diabetes mellitus often suffer from polyneuropathy. Reduced&#xD;
      somatosensation of the feet due to polyneuropathy is one of the major risk factors for&#xD;
      ulceration at the plantar side of the feet and may often cause problems in balance. It has&#xD;
      been shown that the application of a mechanical noise signal to the feet (a vibration with a&#xD;
      random frequency) can reduce the sensation threshold and improve standing balance. However,&#xD;
      techniques used in research so far have several problems that limit applicability in daily&#xD;
      practice. New vibrating insoles have been developed that overcome these problems, but it is&#xD;
      unknown if these insoles have the same effects.&#xD;
&#xD;
      Study population: Two samples of 20 consecutive patients with diabetes mellitus will be&#xD;
      included. Patients will be included if their VPT is between 25 and 45V. Patients with a&#xD;
      history of ulceration on MTP, halllux or heel region will be included in the first sample&#xD;
      group. In the second sample group patients with no history of ulceration will be included.&#xD;
      Patients with an ulceration or (a history of) amputation will be excluded in both groups.&#xD;
&#xD;
      Intervention: First, participants will be standing on vibrating insoles placed on a platform&#xD;
      for the measurement of VPT. Secondly, participants will be standing on a force platform while&#xD;
      wearing standardized shoes in which vibrating insoles are placed. The insoles are either&#xD;
      turned on (i.e. random vibrations applied) or off (i.e. no random vibrations applied).&#xD;
&#xD;
      Main study parameters: Vibration perception threshold and centre of pressure displacements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles</measure>
    <time_frame>One minute</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in center of pressure displacement (balance) between the two conditions.</measure>
    <time_frame>1 minute</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in mediolateral velocity of the centre of pressure displacement between the two conditions (vibrating insoles 'on' or 'off').</measure>
    <time_frame>1 minute</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in anteroposterior velocity of the centre of pressure displacements between the two conditions (insoles 'on' or 'off')</measure>
    <time_frame>1 minute</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetic Neuropathy</condition>
  <arm_group>
    <arm_group_label>Vibrating insoles 'on'</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Duration: 30-60 seconds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibrating insoles 'off'</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Duration: 30-60 seconds</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibrating insoles 'on'</intervention_name>
    <description>Duration: 30-60 seconds</description>
    <arm_group_label>Vibrating insoles 'on'</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus, type I or type II&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Diagnosed with neuropathy&#xD;
&#xD;
          -  VPT between 25-45V&#xD;
&#xD;
          -  Understand Dutch or English&#xD;
&#xD;
          -  Is able to detect the stimulus at full power&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of neuropathic conditions other than diabetes mellitus&#xD;
&#xD;
          -  Problems with the somatosensory or motor system that affect balance or plantar&#xD;
             sensation, not related to DM (for example: CVA)&#xD;
&#xD;
          -  Severe visual problems&#xD;
&#xD;
          -  Current ulcer&#xD;
&#xD;
          -  (a history of) amputation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juha M Hijmans, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Rehabilitation, UMCG</affiliation>
  </overall_official>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Juha M Hijmans</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>diabetic neuropathy</keyword>
  <keyword>foot ulcers</keyword>
  <keyword>random vibration</keyword>
  <keyword>vibration perception threshold</keyword>
  <keyword>mechanical noise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Neuropathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989831
org study id: NL48517.042.14
nct id: NCT02989831
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the effects of vibrating insoles on vibration
      perception threshold (VPT) and balance of people with diabetic neuropathy.
Rationale: People with diabetes mellitus often suffer from polyneuropathy. Reduced
      somatosensation of the feet due to polyneuropathy is one of the major risk factors for
      ulceration at the plantar side of the feet and may often cause problems in balance. It has
      been shown that the application of a mechanical noise signal to the feet (a vibration with a
      random frequency) can reduce the sensation threshold and improve standing balance. However,
      techniques used in research so far have several problems that limit applicability in daily
      practice. New vibrating insoles have been developed that overcome these problems, but it is
      unknown if these insoles have the same effects.

      Study population: Two samples of 20 consecutive patients with diabetes mellitus will be
      included. Patients will be included if their VPT is between 25 and 45V. Patients with a
      history of ulceration on MTP, halllux or heel region will be included in the first sample
      group. In the second sample group patients with no history of ulceration will be included.
      Patients with an ulceration or (a history of) amputation will be excluded in both groups.

      Intervention: First, participants will be standing on vibrating insoles placed on a platform
      for the measurement of VPT. Secondly, participants will be standing on a force platform while
      wearing standardized shoes in which vibrating insoles are placed. The insoles are either
      turned on (i.e. random vibrations applied) or off (i.e. no random vibrations applied).

      Main study parameters: Vibration perception threshold and centre of pressure displacements.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles
time frame: One minute
measure: Difference in center of pressure displacement (balance) between the two conditions.
time frame: 1 minute
measure: Difference in mediolateral velocity of the centre of pressure displacement between the two conditions (vibrating insoles 'on' or 'off').
time frame: 1 minute
measure: Difference in anteroposterior velocity of the centre of pressure displacements between the two conditions (insoles 'on' or 'off')
time frame: 1 minute
arm group label: Vibrating insoles 'on'
arm group type: Experimental
description: Duration: 30-60 seconds
arm group label: Vibrating insoles 'off'
arm group type: No Intervention
description: Duration: 30-60 seconds
intervention type: Device
intervention name: Vibrating insoles 'on'
description: Duration: 30-60 seconds
arm group label: Vibrating insoles 'on'
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juha M Hijmans, PhD
role: Principal Investigator
affiliation: Center for Rehabilitation, UMCG
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Juha M Hijmans
investigator title: PhD
mesh term: Diabetic Neuropathies
sharing ipd: No