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Completed

NCT Number: NCT02989831

The Effect of Random Vibrations on Perception and Balance

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrating insoles 'on'

Device

Duration: 30-60 seconds

Primary outcomes

  1. Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles

    Time frame: One minute

  2. Difference in center of pressure displacement (balance) between the two conditions.

    Time frame: 1 minute

Secondary outcomes

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

    Time frame: 1 minute

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

    Time frame: 1 minute

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

The Effects of Random Vibrations on the Vibratory Perception Threshold of the Foot and Standing Balance in People With Diabetic Neuropathy

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 12, 2016
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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