Diabetic NeuropathyNCT02989831
The Effect of Random Vibrations on Perception and Balance
A study testing Vibrating insoles 'on' in people with Diabetic Neuropathy, run by University Medical Center Groningen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Vibrating insoles 'on'
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Effects of Random Vibrations on the Vibratory Perception Threshold of the Foot and Standing Balance in People With Diabetic Neuropathy
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.
Read the 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
- Being tested
- Vibrating insoles 'on'
- Keywords
- diabetic neuropathy, foot ulcers, random vibration, vibration perception threshold, mechanical noise
- Medical subject headings
- Diabetic Neuropathies, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating insoles 'on'Device
Duration: 30-60 seconds
| Study group | Role | What they receive |
|---|---|---|
| Vibrating insoles 'on' | Experimental | Duration: 30-60 seconds Receives: Device: Vibrating insoles 'on' |
| Vibrating insoles 'off' | No intervention | Duration: 30-60 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles
Measured: One minute
Difference in center of pressure displacement (balance) between the two conditions.
Measured: 1 minute
Secondary outcomes (2)
Difference in mediolateral velocity of the centre of pressure displacement between the two conditions (vibrating insoles 'on' or 'off').
Measured: 1 minute
Difference in anteroposterior velocity of the centre of pressure displacements between the two conditions (insoles 'on' or 'off')
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juha M Hijmans, University Medical Center Groningen
- Investigators
- Juha M Hijmans, PhD, Principal investigator, Center for Rehabilitation, UMCG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989831
- Sponsor's protocol ID
- NL48517.042.14
- Status last verified
- Mar 2020
- First submitted
- 8 Dec 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Random Vibrations on the Vibratory Perception Threshold of the Foot and Standing Balance in People With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT02989831
- Acronym / sponsor ID
- NL48517.042.14
- Conditions
- Diabetic Neuropathy
- Keywords
- diabetic neuropathy, foot ulcers, random vibration, vibration perception threshold, mechanical noise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibrating insoles 'on' | Experimental | Device: Vibrating insoles 'on'Duration: 30-60 seconds |
| Vibrating insoles 'off' | No intervention | –Duration: 30-60 seconds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes mellitus, type I or type II
- Aged 18 years or older
- Diagnosed with neuropathy
- VPT between 25-45V
- Understand Dutch or English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrating insoles 'on'Duration: 30-60 seconds | Device | Vibrating insoles 'on' |
Primary outcome
Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles
Time frame: One minute
Difference in center of pressure displacement (balance) between the two conditions.
Time frame: 1 minute
2 secondary outcomes
Difference in mediolateral velocity of the centre of pressure displacement between the two conditions (vibrating insoles 'on' or 'off').
Time frame: 1 minute
Difference in anteroposterior velocity of the centre of pressure displacements between the two conditions (insoles 'on' or 'off')
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetic Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juha M Hijmans, PhD principal investigator
Center for Rehabilitation, UMCG
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating insoles 'on' in people with Diabetic Neuropathy, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Vibration Perception Threshold (VPT) due to vibrating insoles (time frame: One minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.