Clinical trial NCT02989831: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy
Keywords: diabetic neuropathy
foot ulcers
random vibration
vibration perception threshold
mechanical noise
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles
timeFrame: One minute
measure: Difference in center of pressure displacement (balance) between the two conditions.
timeFrame: 1 minute
Secondary outcomes:
measure: Difference in mediolateral velocity of the centre of pressure displacement between the two conditions (vibrating insoles 'on' or 'off').
timeFrame: 1 minute
measure: Difference in anteroposterior velocity of the centre of pressure displacements between the two conditions (insoles 'on' or 'off')
timeFrame: 1 minute
Other outcomes:
Locations:
Study officials:
affiliation: Center for Rehabilitation, UMCG
name: Juha M Hijmans, PhD
role: PRINCIPAL_INVESTIGATOR
References: