NCT02989831

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

December 8, 2016

Last Update Submit

March 23, 2020

Conditions

Diabetic Neuropathy

Keywords

diabetic neuropathyfoot ulcersrandom vibrationvibration perception thresholdmechanical noise

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Vibrating insoles 'on'

EXPERIMENTAL

Duration: 30-60 seconds

Device: Vibrating insoles 'on'

Vibrating insoles 'off'

NO INTERVENTION

Duration: 30-60 seconds

Interventions

Vibrating insoles 'on'DEVICE

Duration: 30-60 seconds

Vibrating insoles 'on'

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic NeuropathiesFoot Ulcer

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin Ulcer

Study Officials

  • Juha M Hijmans, PhD

    Center for Rehabilitation, UMCG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 12, 2016

Study Start

April 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share