NCT03415256

The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effects of passive vibration (PV) in improving balance and sensation in patients with diabetic peripheral neuropathy (DPN).

Detailed description

The study involves the following: * 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

• Diabetic Neuropathies

Interventions

Type	Name	Description
OTHER	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).
OTHER	no passive vibration	The control group will not receive any treatment and continue their usual lifestyle.

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-11-01
• Completion: 2019-12-01
• First posted: 2018-01-30
• Last updated: 2019-02-28

Locations

1 site across 1 country: United States