The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
NCT ID: NCT03415256
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-11-30
2019-12-31
Brief Summary
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Detailed Description
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* Visit 1:
* Particpant's age, height, gender, and weight will be collected.
* Participant will fill out a questionnaire to assess participant's nerve function. This process will take approximately 2.5 minutes.
* Investigator will measure participant's balance, sensation, and skin blood flow (SBF).
* After completing the tests, participant will be randomly assigned by the computer to either the treatment group or control group.
* The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks.
* The control group will not receive any treatment and they will continue their usual lifestyle.
* Visit 2 through 8:
* The treatment group will receive a passive vibration for 15 minutes followed by SBF measurement.
* The control group will continue their usual lifestyle.
* In the fifth session, the treatment and control groups will come back for tests.
* Visit 9 (follow-up):
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks.
* The control group will not receive any treatment and they will continue their usual lifestyle.
OTHER
NONE
Study Groups
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passive vibration group
The passive vibration group patients will receive passive vibration (50 Hz, one cycle= 60 seconds working time with 2 seconds rest time) on their calf in supine position for ten minutes. The total number of sessions will be nine. Passive vibration will be given to the treatment group twice a week for four weeks (eight sessions) and the ninth session will be the follow up. At every session, the skin blood flow will be measured before, immediately, and 15 minutes after passive vibration.
passive vibration
The passive vibration is delivered using a Physio Plate (Domino S.R.L, San Vendemiano, Italy). The frequency delivered is 50 Hz for a total number of ten cycles for a period of ten minutes approximately (one cycle= 60seconds working time with 2 seconds rest time).
no passive vibration group
The control group will not receive any treatment and continue their usual lifestyle. Balance, sensory measurement and skin blood flow will be taken at the beginning of the study, prior to the 5th treatment, and 1 week after the last intervention .
no passive vibration
The control group will not receive any treatment and continue their usual lifestyle.
Interventions
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passive vibration
The passive vibration is delivered using a Physio Plate (Domino S.R.L, San Vendemiano, Italy). The frequency delivered is 50 Hz for a total number of ten cycles for a period of ten minutes approximately (one cycle= 60seconds working time with 2 seconds rest time).
no passive vibration
The control group will not receive any treatment and continue their usual lifestyle.
Eligibility Criteria
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Inclusion Criteria
* Minimum age 40 years
* Maximum Age 75 years
* Ability to stand for a minimum of five minutes
Exclusion Criteria
* Bleeding Disorders
* Leg Ulcers
* Cardiovascular Diseases
* Complete absence of sensation in lower extremities (i.e. 6.65 in monofilament test)
* Self-reported pregnancy
40 Years
75 Years
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Everett Lohman
Professor
Principal Investigators
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Everett Lohman, DSc
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
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Loma Linda University
Loma Linda, California, United States
Countries
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Other Identifiers
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5170453
Identifier Type: -
Identifier Source: org_study_id
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