The Effect of Random Vibrations on Perception and Balance

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Neuropathy

Intervention / Treatment
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* Device: Vibrating insoles 'on'


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrating insoles 'on'<br>Duration: 30-60 seconds | Device: Vibrating insoles 'on'<br>* Duration: 30-60 seconds<br>|
| No Intervention: Vibrating insoles 'off'<br>Duration: 30-60 seconds | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles |  | One minute | 
| Difference in center of pressure displacement (balance) between the two conditions. |  | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mediolateral velocity of the centre of pressure displacement between the two conditions (vibrating insoles 'on' or 'off'). |  | 1 minute | 
| Difference in anteroposterior velocity of the centre of pressure displacements between the two conditions (insoles 'on' or 'off') |  | 1 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic neuropathy, foot ulcers, random vibration, vibration perception threshold, mechanical noise