Diabetic Neuropathies
Conditions
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):
Interventions
OTHERpassive 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).
OTHERno passive vibration
The control group will not receive any treatment and continue their usual lifestyle.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
* After completing the tests, you 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of Diabetic Peripheral Neuropathy * Minimum age 40 years * Maximum Age 75 years * Ability to stand for a minimum of five minutes
Exclusion criteria
* Neurological Disorders * Bleeding Disorders * Leg Ulcers * Cardiovascular Diseases * Complete absence of sensation in lower extremities (i.e. 6.65 in monofilament test) * Self-reported pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin blood flow | Change between Baseline and Week Nine Visit | Patient will be positioned in prone on a plinth as their skin is marked for blood flow assessment. A 3 cm x 3 cm square shape will be marked on the posterior aspect of the calf (muscle belly) and on the plantar aspect of the first three metatarsal heads. MOOR Full-field Laser Perfusion Image(FLPI) (MOOR FLPI V 2.1, Oxford, England) will be used for measurement of skin blood flow in a patient with DPN, which will be pre-warmed for about 30 minutes. The perpendicular red light laser beam will be used to capture SBF and blood flow is measured in 'Flux unit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| balance | at each of the nine visits( 90 minutes each visit: twice per week) | The NeuroCom Smart Balance Master System Computerized dynamic posturography (CDP) will be used in this research to measure balance. The platform consists of two force plates that can be modulated in the up-down and anterior-posterior direction. The sensory organization test (SOT) will be used to measure balance. The result of CDP determines any anomalies in visual, somatosensory and vestibular systems that control posture. |
Countries
United States
Outcome results
None listed