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临床试验/NCT05319626
NCT05319626已完成不适用

Immediate Effects of Two Different Lower Limb Sensory Stimulation Strategies on Balance and Mobility in Older Adults

Gazi University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Mobility test

研究概览

简要总结

Falls are a major public health problem worldwide. As a result of changes in sensory system capacity with aging, postural control decreases and the risk of falling increases. Various lower-limb sensory stimulation strategies are applied to compensate for these changes in sensory system capacity. It has been determined that these practices can have positive effects on postural control. Among these stimulation strategies, compression stockings and textured insoles are frequently preferred because of their cost-effectiveness and ease of application. For these purpose, this study aims to examine the immediate effects of wearing textured insoles and compression stockings on balance and mobility in older adults. Thus, we will sight to discern whether interventions of the textured insoles and compression materials improve sensory afferent feedback in the foot.

详细描述

Within-subject experimental design with all participants tests under each of four randomly organized conditions: (i) Compression socks with textured insoles, (ii) Compression socks with smooth insoles, (iii) Smooth socks with textured insoles, (iv) Smooth socks with smooth insoles. With each condition, the participants are given a 5-minute warm-up period to get used to the insoles and stocking conditions, and then the testing process consisting of balance, mobility and foot sensation assessments is started. All data are collected randomly in a single testing session by the same researcher blind to the conditions.Before all data collection, each participant has a practice of test process to ensure familiarity with the devices and the procedures. A rest period of 10 minutes are given between applications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Community-dwelling older adults over the 65 years old with ability to stand independently without using any assistive devices
  • No history of falls in the last 12 months
  • Mini Mental State Examination (MMSE) score > 24 (normal)
  • Berg Balance Test score > 40

排除标准

  • Self-reported neurological, vestibular or neuromuscular diseases
  • Current history of peripheral neuropathy
  • Presence of severe visual impairment (such as cataracts or glaucoma)

结局指标

主要结局

Mobility test

时间窗: in an average of one and half hour

Mobility will be assessed by selecting Time Up and Go and Walk parameters in the BTS G-Walk wearable motion analysis system. Time Up and Go test determines functional mobility, and fall risk. Walk test evaluates quantitative analysis for the performance of walking. It will be measured with each condition, 4 times in total.

Balance test

时间窗: in an average of one and half hour

Balance will be assessed using the Biodex-BioSway™ Portable Balance System, in different visual situations and support surfaces during bilateral standing. It will be measured with each condition, 4 times in total.

Foot sensation test

时间窗: in an average of one and half hour

Foot plantar sense will be assessed with Semmes-Weinstein monofilament test. The foot sensation test will be performed (barefoot) immediately after each condition to determine the effect of the condition. 4 times in total.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevim Beyza Ölmez

Principal Investigator

Gazi University

研究点 (2)

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