跳至主要内容
临床试验/CTRI/2024/10/075765
CTRI/2024/10/075765已完成不适用

Effect of Square Stepping Exercise on balance and risk of fall in subjects with Diabetic Neuropathy.

Trishna Deka3 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
3
主要终点
Berg Balance Scale

研究概览

简要总结

Diabetic Neuropathy (DN) is one of the commonest causes of peripheral neuropathy and is defined as signs and symptoms of peripheral nerve dysfunction in a patient with diabetes mellitus in whom other causes of peripheral nerve dysfunction have been excluded. When compared to people with T1DM, the incidence is greater in T2DM. Individuals with diabetes are susceptible to developing neuropathy at any point, with an increased risk correlating with advancing age and a duration of diabetes exceeding five years. Diabetic neuropathy is a major cause of falls in elderly patients and people with peripheral neuropathy caused by diabetes often experience balance disorders. Patients with this condition experience more postural sway, particularly when their eyes are closed. Exercise has been shown to enhance various metabolic factors that can influence nerve health and micro-vascular function, potentially providing indirect protection against peripheral nerve damage. Patients with diabetic neuropathy benefit from exercise therapy, including balance exercises, since it increases oxygen pressure in the skin, lower limbs, and chest, hence improving skin blood flow. Alterations in shear stress and pressure on the plantar surfaces during standing tasks can activate mechanoreceptors, transmitting signals to higher nervous centres and thereby, enhancing balance in patients with diabetic neuropathy. Research suggests that Square Stepping Exercise is an apparently most effective alternative to walking for improvement of balance. Its effectiveness has been shown to be beneficial for subjects with stroke, Parkinson’s Disease, Multiple Sclerosis and elderly population. But there is a dearth of literature concerning Diabetic Neuropathy. Hence, the present study is developed with the aim to investigate the effect of SSE on balance and risk of falls in subjects with Diabetic Neuropathy. This study will include 62 participants, who will be divided equally into two groups: Group A & Group B. Participants in Group A will receive Square Stepping Exercise and Group B will receive Conventional Therapy. Both groups will receive intervention for 50 minutes with 10 minutes of warm-up and cool-down period, 3 times a week for 8 weeks. Data will be collected from both the groups pre and post intervention by using Berg Balance Scale and Timed Up and Go test. Statistical analysis will be done by Statistician to compare the results.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
45.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Type 2 Diabetes Mellitus subjects (duration more than 5 years).
  • Michigan Neuropathy Screening Instrument, Physical Assessment Score more than 2 out of
  • Subjects with Fear of Fall (FES-I Score more than 20).
  • Ability to walk independently without an assistive device.

排除标准

  • Subjects having diabetic foot ulcers, partial or total foot amputation.
  • Subjects with any other neurological or musculoskeletal impairments.
  • Subjects with major vascular complications (venous/arterial ulcers).
  • Subjects with severe retinopathy or severe nephropathy.
  • Subjects with severe psychiatric illness.
  • Subjects with severe hearing and visual deficits.
  • Non-cooperative subjects.
  • Existence of any other factors that interfere with balance except Diabetic Neuropathy.

结局指标

主要结局

Berg Balance Scale

时间窗: Maximum Score 56

次要结局

  • Timed Up and Go (TUG) Test(Normal is 10 seconds or less)

研究者

发起方
Trishna Deka
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Trishna Deka

Padmashree Institute of Physiotherapy

研究点 (3)

Loading locations...

相似试验

Impact of Square Stepping Exercise on balance and... | 临床试验