The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Skin blood flow
研究概览
简要总结
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).
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of Diabetic Peripheral Neuropathy
- •Minimum age 40 years
- •Maximum Age 75 years
- •Ability to stand for a minimum of five minutes
排除标准
- •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
研究组 & 干预措施
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.
干预措施: passive vibration (Other)
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 .
干预措施: no passive vibration (Other)
结局指标
主要结局
Skin blood flow
时间窗: 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.
次要结局
- balance(at each of the nine visits( 90 minutes each visit: twice per week))
研究者
Everett Lohman
Professor
Loma Linda University