跳至主要内容
临床试验/NCT07515157
NCT07515157已完成不适用

Investigation of the Effects of Light-up Shoes on Balance, Fall Risk, and Walking in Geriatric Indivuduals

Kirsehir Ahi Evran Universitesi1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Berg Balance Scale

研究概览

简要总结

Objectives: The aim of this study is to investigate the effects of a light-up shoe that creates visual stimuli on balance, walking and fall risk in geriatric individuals.

Methods: Fifty-two geriatric individuals who agreed to participate in this study were assessed under four conditions: 1. barefoot, 2. oxford-type shoes, 3. daily shoes, and 4. light-up shoes that activate when weight is applied to the foot. Balance, walking and fall risk were evaluated in geriatric individuals.

详细描述

Introduction Aging is a gradual, irreversible process in which individuals lose mental and physiological abilities and is considered a normal process. As the body ages, physiological changes occur. These changes affect the body, organs, and systems, leading to a decrease in functionality, loss of function, and a general decline in abilities. Eventually, these changes impact the independence of geriatric individuals in daily activities and quality of life.

As people age, many experience significant declines in balance performance. A decrease in somatosensory information (visual, proprioceptive, and vestibular) can lead to postural control deficits in geriatric populations. As age progresses, a decrease in somatosensory information affects individuals' quality of life. Declines in visual acuity, illumination levels, sensitivity to bright lights, and dark adaptation functions increase with age. Over 90% of geriatric individuals wear glasses. One-fifth of those aged 85 and above have difficulty seeing even with glasses. Additionally, changes in surface sensation and proprioception are commonly linked to poor function and postural control in older adults. These factors can increase the incidence of falls. Nearly one-third of older adults experience falls, which can result in disability, loss of independence, functional deterioration, and even death.

Geriatric individuals often wear different types of shoes for daily activities, with sports shoes and medical shoes being the most common. Shoes can significantly impact postural balance. Individuals can filter sensory information between the feet and the external environment, thereby altering the quality of sensory feedback from the feet. Traditionally, the design of shoes aims to enhance stability, provide support to the foot during movement, and control foot motions such as pronation. Evidence suggests that certain features, such as heel height, heel counter height, and sole thickness and stiffness, can improve balance. Improper footwear can impair balance and gait, and research has shown that different types of shoes have varying effects on balance.

Studies in the literature have shown that vibrating insoles and auditory stimuli can reduce changes in gait in geriatric individuals. However, there is no study reflecting the deficiencies in visual perception in the shoe content. The aim of study is to investigate the effects of a light-up shoe that provides visual stimuli on balance, gait, and fall risk in geriatric individuals.

Materials and methods Fifty-two individuals aged 65 and older who had applied to the Physical Therapy and Rehabilitation Department were included. The inclusion criteria were being over the age of 65, living independently in the community, agreeing to participate voluntarily, being capable of independent mobility, and having no neurological or musculoskeletal diagnoses (such as cerebrovascular accidents or lower extremity joint replacements). Individuals were excluded had peripheral sensory neuropathy, inner ear problems, visual disturbances, deformities that restricted standing, or dementia. Written informed consent was obtained from all participants in accordance with the guidelines approved by the local ethical committee and the Declaration of Human Rights, Helsinki.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • being over the age of 65
  • living independently in the community,
  • agreeing to participate voluntarily,
  • being capable of independent mobility,
  • having no neurological or musculoskeletal diagnoses

排除标准

  • had peripheral sensory neuropathy,
  • inner ear problems,
  • visual disturbances,
  • deformities that restricted standing,

研究组 & 干预措施

Barefoot

Active Comparator

52 geriatric individuals who agreed to participate in this study were evaluated: 1. with barefoot, 2. with oxford-style shoes, 3. with the shoes use daily, 4. with a shoe that emits light when weight is placed on the sole of foot. It is known that using a single measurement to determine balance, fall risk, and functional parameter values, especially in geriatric individuals, is not appropriate because time-dependent issues cannot be captured in just one assessment.

干预措施: barefoot (Behavioral)

oxford-style shoes

Active Comparator

52 geriatric individuals who agreed to participate in this study were evaluated: 1. with barefoot, 2. with oxford-style shoes, 3. with the shoes use daily, 4. with a shoe that emits light when weight is placed on the sole of foot. It is known that using a single measurement to determine balance, fall risk, and functional parameter values, especially in geriatric individuals, is not appropriate because time-dependent issues cannot be captured in just one assessment.

干预措施: with oxford-style shoes (Behavioral)

with the shoes use daily

Active Comparator

52 geriatric individuals who agreed to participate in this study were evaluated: 1. with barefoot, 2. with oxford-style shoes, 3. with the shoes use daily, 4. with a shoe that emits light when weight is placed on the sole of foot. It is known that using a single measurement to determine balance, fall risk, and functional parameter values, especially in geriatric individuals, is not appropriate because time-dependent issues cannot be captured in just one assessment.

干预措施: with a shoe that emits light (Behavioral)

with a shoe that emits light

Experimental

52 geriatric individuals who agreed to participate in this study were evaluated: 1. with barefoot, 2. with oxford-style shoes, 3. with the shoes use daily, 4. with a shoe that emits light when weight is placed on the sole of foot. It is known that using a single measurement to determine balance, fall risk, and functional parameter values, especially in geriatric individuals, is not appropriate because time-dependent issues cannot be captured in just one assessment.

干预措施: with the shoes use daily (Behavioral)

结局指标

主要结局

Berg Balance Scale

时间窗: 3 week

The Berg Balance Scale, consisting of 14 items, assesses balance using a 5-point scoring system ranging from 0 to 4. A score of 0 indicates that the movement cannot be performed, while a score of 4 indicates that the movement can be completed optimally. The maximum score on the scale is 56, with higher scores representing better balance performance.

次要结局

  • Timed-up and Go Test(3 week)
  • Tinetti Falls Efficacy Scale(3 week)

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Buket Büyükturan

Principal Investigator

Kirsehir Ahi Evran Universitesi

研究点 (1)

Loading locations...

相似试验