The Effect of Random Vibrations on Perception and Balance

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Diabetic Neuropathy

Treatments

Device: Vibrating insoles 'on'

Study type

Interventional

Funder types

Other

Identifiers

NCT02989831

NL48517.042.14

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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