Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-03 @ 2:18 PM
Study NCT ID:
NCT03415256
Status:
WITHDRAWN
Last Update Posted:
2019-02-28
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
Sponsor:
Loma Linda University
Organization:
Study Overview
Official Title:
The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of time currently.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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):
* 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):
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: