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Geriatric IndividualsGeriatricNCT07515157

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

A study testing barefoot, with oxford-style shoes and with the shoes use daily in people with Geriatric Individuals, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Geriatric Individuals
What is being tested?
barefoot, with oxford-style shoes and with the shoes use daily
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Jun 2018to 3 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kırşehir Ahi Evran Univercity

    Kırşehir, Kırşehir, 40100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

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.

Being tested
barefoot, with oxford-style shoes, with the shoes use daily, with a shoe that emits light
Keywords
balance, Geriatry, Light-up shoes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • barefootBehavioural

    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 shoesBehavioural

    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 dailyBehavioural

    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 lightBehavioural

    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.

Study groups in NCT07515157
Study groupRoleWhat they receive
BarefootActive comparator52 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.
Receives: Behavioral: barefoot
oxford-style shoesActive comparator52 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.
Receives: Behavioral: with oxford-style shoes
with the shoes use dailyActive comparator52 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.
Receives: Behavioral: with a shoe that emits light
with a shoe that emits lightExperimental52 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.
Receives: Behavioral: with the shoes use daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Berg Balance Scale

    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.

    Measured: 3 week

Secondary outcomes (2)
  1. Timed-up and Go Test

    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.

    Measured: 3 week

  2. Tinetti Falls Efficacy Scale

    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.

    Measured: 3 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start3 Jun 2018
  3. Primary completion28 Jun 2018
  4. Study completion3 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07515157
Sponsor's protocol ID
2018-13/112
Acronym
Geriatric
Status last verified
Mar 2026
First submitted
24 Mar 2026
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patient information should not be shared to protect confidentiality and privacy. According to ethical principles, including the Declaration of Helsinki, and legal regulations such as KVKK (Personal Data Protection Law in Turkey), identifiable personal and health data must remain confidential.

Publications

  • Küçük U, Karadeniz H. Yaşlanmaya bağlı bireylerde görülen fizyolojik, ruhsal, sosyal değişiklikler ve korunmaya yönelik önlemler. Yaşlı Sorunları Araştırma Dergisi. 2021; 14(2): 96-103. https://doi.org/10.46414/yasad.877517

  • Arnadottir SA, Mercer VS. Effects of footwear on measurements of balance and gait in women between the ages of 65 and 93 years. Phys Ther. 2000 Jan;80(1):17-27.

    PubMed 10623957

Questions about this trial

What is this clinical trial studying?

A study testing barefoot, with oxford-style shoes and with the shoes use daily in people with Geriatric Individuals, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (time frame: 3 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07515157, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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