The Effect of Random Vibrations on Perception and Balance

NCT ID: NCT02989831

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-10-31

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.

Conditions

Diabetic Neuropathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Vibrating insoles 'on'

Duration: 30-60 seconds

Group Type: EXPERIMENTAL

Vibrating insoles 'on'

Intervention Type: DEVICE

Duration: 30-60 seconds

Vibrating insoles 'off'

Duration: 30-60 seconds

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vibrating insoles 'on'

Duration: 30-60 seconds

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Juha M Hijmans

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juha M Hijmans, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Rehabilitation, UMCG

Other Identifiers

NL48517.042.14

Identifier Type: -

Identifier Source: org_study_id