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Biodex Balance System Training in Diabetic Neuropathy

2021年12月13日 更新者:Riphah International University

Effect of BIODEX Balance System Training on Balance in Type II-diabetic Neuropathy.

Type II-diabetic neuropathy is the most common and correlated problem with diabetes that deteriorates with the passage of time. Balance disorders are also resulting of movement strategy damage, biomechanical and mechanical disorientation. The balance disorder has been reported to be related to abnormal somatosensory feedback, which is utilized in the development of an interior depiction of body motion and position (inner model) in the central nervous system. The Biodex stability system offers a system that can deliver particular hip and ankle postural training strategy with external biofeedback as a monitor to enhance the reduced subclinical limitations of patients with diabetic neuropathy.

研究概览

详细说明

Diabetes mellitus is one of the most common critical illnesses with a higher prevalence all over the world. Diabetic neuropathy is the most common and correlated problem with diabetes that deteriorates with the passage of time. Diabetic neuropathy is a progressive and complex disease, characterized by regular distal deterioration of peripheral nerves which lead to symptoms of sensory loss and pain. During normal situations, somatosensory inputs from the feet and legs participate in the stability of posture. Posture reflex and balance alignment are common findings in diabetic neuropathy because of reduced proprioception and rising time of reflex reactions. Balance disorders are also results of movement strategy damage, biomechanical and mechanical disorientation.

About 20-30% of patients with diabetic neuropathy suffer from neuropathic pains.

Neuropathic complications are prevalent among 39.6% of the diabetic population. Diabetic neuropathy lowers significantly the quality of life and considerably increases health expenses related to diabetes. Diabetic neuropathy patients exhibit stability disorders and are vulnerable to falls even with open eyes. The instability sources in patients with type-II diabetic neuropathy comprise the incapability of the central nervous system (CNS) to integrate properly available information of postural control and a shift of balance strategy from ankle-based to hip-based. Furthermore, a rise in the reliance on visual information and the use of vestibular information change the format of postural control in patients with diabetic neuropathy.

Stability can be referred to as the warmth of a dynamic system to different worries, and local constancy is the sensitivity of the structure to internal distresses, for example, natural fluxes like variation in muscle activity respond to gravity which occurs during stability. The impacts of such natural variations were inspected for assessing diverse measures of postural influence. Multiple studies on diabetic patients by neuropathic postural instability recommend relative shortfalls in their capability to sustain posture and specify higher instability as compared to non-diabetics and positive relations between falling and postural instability.

Moreover, studies of posture instability in diabetic patients with diabetic neuropathy have shown greater scores for postural stability indexes, area of sway, speed, greater ranges of the centre of pressure; increased values of the centre of mass variables and increase of sway power in less stable postures. Awareness and appropriately performing balance and stability training in patients involve comprehensive knowledge of the causes of postural complications. Postural control involves a composite organization that controls the equilibrium and orientation of the body during upright stand.

In addition, posture control involves multiple underlying physiological organizations and dependent upon six contexts: (a) cognitive processing, (b) sensory approaches, (c) movement approaches, (d) dynamics control (e), space orientation and (f) biomechanical task limitations. The sensory afferents sources which seem to participate in postural control comprise proprioception, visual systems, and vestibular. Subclinical and pathological constrictions in patients with diabetic neuropathy are because of context-specific and distinct instabilities like sensory and movement approaches. Reactive movement approaches are helpful for patients in developing multi-joint coordinated movement, and sensory approaches for selecting proper sensory information to control posture. The hip and ankle reactive movement approach reported being helpful to return the equilibrium of the body and keeping the feet in position. When people stand on a rigid surface, the ankle approach maintains balance with little movements in the form of an inverted pendulum. Rehabilitation and reactive movement strategies comprise the patient's exposure to external perturbations which differ in direction, amplitude, and speed. However, few studies have reported the correlation between balance training and external response. These trainings are useful to progress the sensory integration and dynamic balance capabilities of aged adults with a falling history and support for frail aged women in domestic care.

It also has been ideal to balance training at home. In addition, static-standing stability can be trained efficiently through weight-bearing exercise, and a visual guided weight-shifting drill can develop a standing balance mechanism of static balance in diabetic neuropathy patients. Like so, the BIODEX stability system offers a system that can deliver particular hip and ankle postural training strategy with external biofeedback as a monitor to enhance the reduced subclinical limitations of patients with diabetic neuropathy. As these patients are often of old age and have symptoms of instability identical to those of elder people, it is supposed that a balance-training platform with a BIODEX balance system may also improve balance in patients with diabetic neuropathy

研究类型

介入性

注册 (实际的)

88

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Rawalpindi、巴基斯坦
        • Armed Forces Institute of Rehabilitation And Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 70年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age over 40 years both gender
  • moderate & severe Type 2 diabetic neuropathy (modified Toronto Clinical Neuropathy Score) 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy
  • Ability to stand and walk independently.
  • Berg balance score <50
  • No cognitive impairments (Mini-Mental State Examination >23)

Exclusion Criteria:

  • Individuals with other neurological deficits.
  • Type 1 diabetic neuropathy.
  • Diabetic ulcer, infection or partial amputation in feet.
  • Orthopedic problem or severe pain affecting balance.
  • History of repeated ankle sprains
  • Visual problems.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:BIODEX training group
These individuals will receive conventional along with postural stability training with biodex balance system which stimulates specific movement patterns or strategies by placing markers on a specific location on-screen grid subject attempted to touch targets nine times using an onscreen cursor manoeuvred by the subject leg on the device platform
BIODEX stability system (BIODEX Medical Systems Inc; Shirley, New York) offers a system that can deliver particular hip and ankle postural training strategy with external biofeedback as a monitor to enhance the reduced subclinical limitations of patients with diabetic neuropathy
有源比较器:Conventional therapy group
These individuals will perform balance exercises including proprioception exercises, balance board exercises, walking on different surfaces, Wobble board exercise and parallel bars for ambulatory training, range of motion exercises, foot care as a home program (advices).
balance board exercises, walking on different surfaces, Wobble board exercise and parallel bars for ambulatory training, range of motion exercises, foot care as a home program. Same duration treatment

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Berg Balance Scale
大体时间:week 8
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. 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 and takes approximately 20 minutes to complete
week 8
Timed up and go test
大体时间:week 8

The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). The TUG can be used with but is not limited to, persons with stroke.

10s Completely independent With or without walking aid for ambulation and transfers

< 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone

> 30s Requires assistance Dependent in most activities

week 8
Functional reach test
大体时间:week 8

The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults.

Interpretation: A score of 6 or less indicates a significant increased risk for falls. A score between 6-10 inches indicates a moderate risk for falls

week 8

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年12月1日

初级完成 (实际的)

2021年8月27日

研究完成 (实际的)

2021年8月27日

研究注册日期

首次提交

2021年6月21日

首先提交符合 QC 标准的

2021年6月21日

首次发布 (实际的)

2021年6月29日

研究记录更新

最后更新发布 (实际的)

2021年12月15日

上次提交的符合 QC 标准的更新

2021年12月13日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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Biodex balance system的临床试验

3
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