Whole-Body Vibration Versus Kineso Tape on Nerve Conduction in Patient With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Deep peroneal nerve motor conduction velocity
研究概览
简要总结
The purpose of the study was to compare between effect of whole-body vibration and kineso tape on nerve conduction in patients with diabetic peripheral neuropathy.
详细描述
Diabetes is a huge and rapidly growing health problem worldwide. In 2019, International Diabetes Federation ( IDF) estimated that the number of people with diabetes was 463 million and expected to be 578 million by 2030, and 700 million by 2045. Two-thirds of people with diabetes live in urban areas, and one in five people with diabetes is above 65 year.
Diabetic peripheral neuropathy is the most prevalent complication of diabetes mellitus. The prevalence of DPN ranges from 21.3 to 34.5% in type 2 DM (T2DM) and between seven to 34.2% in type 1 DM (T1DM).
The high incidence and prevalence of falls among older people with type 2 diabetes mellitus were identified as poor diabetic control, diabetic peripheral neuropathy (DPN) and balance impairment.
Study performed by Ahmed et al., reported that Kinesio tape and resistive exercise improve the dorsiflexors and functional performance in diabetic polyneuropathy.
A randomized controlled trial showed that WBV showed beneficial effects on pain, balance, and quality of life in patients with painful Diabetic peripheral neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients type 2 diabetes with duration at least 10 years.
- •Controlled blood glucose level examined via glycated hemoglobin exam (hba1cless than 9 and more than 6.5).
- •Age of patient will range from 50 to 60 years.
- •Patients had abnormal nerve conduction study.
排除标准
- •Patients having ulceration/infection of feet
- •Medical/Surgical conditions limiting functional mobility
- •Non-ambulatory patients
- •Who are not willing to participate?
- •Subjects with Type 1 Diabetes mellitus.
- •Subjects with Gestational Diabetes.
- •Subjects who are seriously ill.
- •Lower limb fracture or trauma
- •Significant renal hepatic disorder
结局指标
主要结局
Deep peroneal nerve motor conduction velocity
时间窗: 6 weeks
It was measured for all participants in both groups before and after treatment, using Neuropack S1 MEB-9004 NIHON KODEN, JAPAN nerve conduction velocity device.
Sural nerve sensory conduction velocity
时间窗: 6 weeks
It was measured for all participants in both groups before and after treatment, using Neuropack S1 MEB-9004 NIHON KODEN, JAPAN nerve conduction velocity device.
Berg Balance Scale
时间窗: 6 weeks
It was used to measure the balance for all participants in both groups before and after treatment. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. The scale takes approximately 10 to 20 minutes to complete requiring minimal equipment (chair, stopwatch, ruler, and step) and minimal space Berg balance have high validity and reliability. Interpretation: 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk.
Quadriceps femoris muscle strength
时间窗: 6 weeks
It was assessed for all participants in both groups before and after treatment, using hand held dynamometry. To evaluate quadriceps muscle strength, the patients were positioned in the prone position, lying with the knee flexed to 90 degrees; the dynamometer was fixed proximal to the ankle on the anterior surface of the leg; and the subjects were asked to perform isometric knee extension. Three maximal isometric contractions were recorded, and the average of the three trials was used for analysis.
Tibialis anterior muscle strength
时间窗: 6 weeks
It was assessed for all participants in both groups before and after treatment, using hand held dynamometry. To evaluate tibialis anterior strength, patients were asked to lie supine with their ankles at the edge of the plinth. The ankle joints were placed in the neutral position (between dorsiflexion and plantar flexion). The dynamometer was fixed to the dorsal aspect of the foot, and each subject was asked to perform isometric dorsiflexion. Three maximal isometric contractions were recorded, and the average of the three trials was used for analysis.
Unilateral Stance Test (UST)
时间窗: 6 weeks
It was used to assess postural balance for all participants in both groups before and after treatment. Each subject was instructed to maintain balance on the nondominant leg with eyes opened, eyes closed, and arms spread for as long as possible. The time taken for the contralateral foot to touch the ground was measured in seconds using a stopwatch. This test was performed twice, and the highest score was recorded.
Smartphone Kinesis Balance™ fall prevention app
时间窗: 6 weeks
It was used to assess balance and falls risk for all participants in both groups before and after treatment. The app is freely available on the Google Play store, with participants consenting to use of their anonymized data for research and product improvement. The app uses a questionnaire on clinical falls risk factors, combined with a standing balance test and machine learning algorithms to assess balance and falls risk. Participants are provided with advice and exercises to stay healthy and help prevent falls, based on their level of risk (as determined by the smartphone based machine learning algorithm). All data were anonymized at source and transmitted via encrypted channel to a web server where they were stored (in line with GDPR and HIPAA data privacy regulations) for subsequent offline analysis. Data were extracted from the database using MySQL workbench 8.0 (Oracle, CA, USA) and analyzed using Matlab v 9.3.0 (Mathworks, Natick, VA, USA).
次要结局
未报告次要终点
研究者
Lamis Samir Ahmed
Principal Investigator
Cairo University