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
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
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
NCT ID
NCT02989831
First Posted
December 8, 2016
Last Updated
March 23, 2020
Sponsor
University Medical Center Groningen
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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