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Completed

NCT Number: NCT07515157

Light-Up Shoes on Balance, Fall Risk, and Walking in Geriatric Individuals

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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırşehir Ahi Evran Univercity

Kırşehir, 40100, Turkey (Türkiye)

About this study

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.

52 geriatric individuals who agreed to participate in this study were evaluated: 1. with barefoot, 2. with oxford-style shoes, 3. with the shoes to 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. Given the lengthy measurement process in this study, it was anticipated that the geriatric participants might experience fatigue, which could affect the accuracy of the results. To mitigate time-dependent issues, these assessments were repeated under the same conditions over three consecutive weeks. The average of these three values was recorded as the individual's balance, fall risk, and functional parameter scores. It is important to note that all measurements in this study were conducted with the participants' eyes open. This is because most daily activities are performed with eyes open.

Outcome Measures Baseline data, including age, gender, body mass index, and mini mental state examination scores, were recorded.

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.

Timed-up and Go Test: Functional performance was evaluated using test. Participants were asked to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The test result for each participant was recorded in seconds using a stopwatch.

Tinetti Falls Efficacy Scale assesses the level of self-perceived fear of falling during daily activities in the geriatric. It consists of 10 simple indoor activities rated on a 10-point scale, with total scores ranging from 10 to 100. Lower scores indicate a lower level of confidence.

Statistical Analysis: Statistical analyses were performed using SPSS software (Version 22.0; SPSS Inc., Chicago, Illinois). Visual methods (histograms, probability plots) and analytical methods (Kolmogorov-Smirnov test) were used to determine whether the variables were normally distributed. For normally distributed variables, descriptive analyses were presented as mean ± SD. A one-way repeated-measures analysis of variance with a Bonferroni-adjusted post hoc test was used to compare means between each assessment. A P-value of less than 0.05 was considered statistically significant.

The necessary sample size was estimated using G*Power 3.1.9.2 for Windows (G*Power©️, University of Dusseldorf, Germany). A sample size of 52 provided 80% power at p<0.05 for repeated measurements of one sample including four different insole conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

barefoot

Behavioral

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.

with oxford-style shoes

Behavioral

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.

with the shoes use daily

Behavioral

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.

with a shoe that emits light

Behavioral

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.

Primary outcomes

  1. Berg Balance Scale

    Time frame: 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.

Secondary outcomes

  1. Timed-up and Go Test

    Time frame: 3 week

    Functional performance was evaluated using the Timed-up and Go Test. Participants were asked to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The test result for each participant was recorded in seconds using a stopwatch.

  2. Tinetti Falls Efficacy Scale

    Time frame: 3 week

    The Tinetti Falls Efficacy Scale assesses the level of self-perceived fear of falling during daily activities in the geriatric. It consists of 10 simple indoor activities rated on a 10-point scale, with total scores ranging from 10 to 100. Lower scores indicate a lower level of confidence.

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

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

Acronym: Geriatric

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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