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The Effect of Random Vibrations on Perception and Balance

Primary Purpose

Diabetic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vibrating insoles 'on'
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Neuropathy focused on measuring diabetic neuropathy, foot ulcers, random vibration, vibration perception threshold, mechanical noise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetes mellitus, type I or type II
  • Aged 18 years or older
  • Diagnosed with neuropathy
  • VPT between 25-45V
  • Understand Dutch or English
  • Is able to detect the stimulus at full power

Exclusion Criteria:

  • A history of neuropathic conditions other than diabetes mellitus
  • Problems with the somatosensory or motor system that affect balance or plantar sensation, not related to DM (for example: CVA)
  • Severe visual problems
  • Current ulcer
  • (a history of) amputation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Vibrating insoles 'on'

    Vibrating insoles 'off'

    Arm Description

    Duration: 30-60 seconds

    Duration: 30-60 seconds

    Outcomes

    Primary Outcome Measures

    Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles
    Difference in center of pressure displacement (balance) between the two conditions.

    Secondary Outcome Measures

    Difference in mediolateral velocity of the centre of pressure displacement between the two conditions (vibrating insoles 'on' or 'off').
    Difference in anteroposterior velocity of the centre of pressure displacements between the two conditions (insoles 'on' or 'off')

    Full Information

    First Posted
    December 8, 2016
    Last Updated
    March 23, 2020
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02989831
    Brief Title
    The Effect of Random Vibrations on Perception and Balance
    Official Title
    The Effects of Random Vibrations on the Vibratory Perception Threshold of the Foot and Standing Balance in People With Diabetic Neuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Neuropathy
    Keywords
    diabetic neuropathy, foot ulcers, random vibration, vibration perception threshold, mechanical noise

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vibrating insoles 'on'
    Arm Type
    Experimental
    Arm Description
    Duration: 30-60 seconds
    Arm Title
    Vibrating insoles 'off'
    Arm Type
    No Intervention
    Arm Description
    Duration: 30-60 seconds
    Intervention Type
    Device
    Intervention Name(s)
    Vibrating insoles 'on'
    Intervention Description
    Duration: 30-60 seconds
    Primary Outcome Measure Information:
    Title
    Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles
    Time Frame
    One minute
    Title
    Difference in center of pressure displacement (balance) between the two conditions.
    Time Frame
    1 minute
    Secondary Outcome Measure Information:
    Title
    Difference in mediolateral velocity of the centre of pressure displacement between the two conditions (vibrating insoles 'on' or 'off').
    Time Frame
    1 minute
    Title
    Difference in anteroposterior velocity of the centre of pressure displacements between the two conditions (insoles 'on' or 'off')
    Time Frame
    1 minute

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diabetes mellitus, type I or type II Aged 18 years or older Diagnosed with neuropathy VPT between 25-45V Understand Dutch or English Is able to detect the stimulus at full power Exclusion Criteria: A history of neuropathic conditions other than diabetes mellitus Problems with the somatosensory or motor system that affect balance or plantar sensation, not related to DM (for example: CVA) Severe visual problems Current ulcer (a history of) amputation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juha M Hijmans, PhD
    Organizational Affiliation
    Center for Rehabilitation, UMCG
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of Random Vibrations on Perception and Balance

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