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临床试验/NCT06130865
NCT06130865尚未招募不适用

Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy

Riphah International University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
104
试验地点
1
主要终点
Mini Balance Evaluation Systems Test (mini-BESTest)

研究概览

简要总结

Their is limited literature available regarding the assessment of balance by Fullerton Advanced Balance scale in patients with diabetic peripheral neuropathy, previous studies have only focused on the use of berg balance scale and mini-BESTest. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the patients of diabetic peripheral neuropathy.

详细描述

Diabetes is a serious, long-term condition with a major impact on the lives and well-being of individuals, families, and societies worldwide. Diabetic neuropathy is its most common clinical consequence. Diabetic Peripheral Neuropathy (DPN) is defined as "the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes." A person with DPN is up to 20 times more likely to fall than a non-diabetic of the same age, making falls an even more significant therapeutic concern. As a result of decreased balance, people with DPN are predisposed to falls, which can lead to injury, decreased balance confidence, fear-related avoidance of activities, and decreased quality of life. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the population of DPN and it will also predict which of them is the most responsive and sensitive and first evaluates changes in balance of patients with DPN. After the comparison of responsiveness and sensitivity of these scales, it can predict the best tool for early assessment of balance impairment in the people with DPN. This study will be beneficial in early identification of fall risk and minimization of fall related injuries and complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Either gender.
  • Age between 40 to 60 years
  • Known history of diabetes mellitus treated with by oral hypoglycemic drugs or insulin therapy.
  • Known case of diabetic peripheral neuropathy (DPN)
  • Patients who met the criteria of DN4 scored equal or greater than
  • Patients who have positive SHARPEND ROMBERG TEST.
  • Balance impairment on BBS (21-40).

排除标准

  • Lower limb muscles strength less than 3 on manual muscle testing.
  • Any inflammatory condition, congenital or acquired malformation, vestibular system pathologies.
  • Contraindication for engaging in physical activity (osteoarthritis, orthostatic hypo tension or any acute illness).

结局指标

主要结局

Mini Balance Evaluation Systems Test (mini-BESTest)

时间窗: 8 weeks

A clinical tool that assesses balance impairments by evaluating various components of balance control, including anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability during gait.

Fullerton Advanced Balance Scale (FAB)

时间窗: 8 weeks

The FAB scale is a multi-item balance assessment test designed specifically to measure balance in higher-functioning active older adults.

Berg Balance Scale

时间窗: 8 Weeks

A clinical tool that assesses static and dynamic balance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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