- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515157
Light-Up Shoes on Balance, Fall Risk, and Walking in Geriatric Individuals (Geriatric)
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kırşehir
-
Kırşehir, Kırşehir, Turkey (Türkiye), 40100
- Kırşehir Ahi Evran Univercity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Barefoot
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.
|
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.
|
|
Active Comparator: oxford-style shoes
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.
|
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.
|
|
Active Comparator: with the shoes use daily
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.
|
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.
|
|
Experimental: with a shoe that emits light
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 week
|
|
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.
|
3 week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-13/112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Geriatric Individuals
-
Hasan Kalyoncu UniversityActive, not recruitingGeriatric | Geriatric IndividualsTurkey (Türkiye)
-
Müşerref Ebru YALÇINCompletedCognitive Function | Physical Performance | Geriatric IndividualsTurkey (Türkiye)
-
Inonu UniversityNot yet recruitingComparison of the Effects of Different Therapies in Geriatric IndividualsTurkey (Türkiye)
-
Hacettepe UniversityCompletedGeriatric IndividualsTurkey
-
Hacettepe UniversityCompletedInvestigation of Inspiratory Muscle Strength and Cardiorespiratory Fitness in Sarcopenic IndividualsGeriatric IndividualsTurkey
-
Acibadem UniversityBiruni UniversityEnrolling by invitationGeriatric | Geriatric Fall | Geriatric Health | Geriatrics RehabilitationTurkey (Türkiye)
-
USDA Grand Forks Human Nutrition Research CenterRecruiting
-
Universidade Federal de PernambucoRecruitingHealthy IndividualsBrazil
-
University of British ColumbiaRecruiting
-
University of British ColumbiaCompletedHealthy IndividualsCanada
Clinical Trials on barefoot
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
University of MalagaActive, not recruiting
-
Elisabetta BrigoRecruitingPlantar Fasciitis | Plantar Fasciopathy | Plantar Fasciitis, Chronic | Heel PainIreland
-
University of Sao PauloCompleted
-
Universidade Estadual de LondrinaCompleted
-
University of LiverpoolLiverpool University Hospitals NHS Foundation TrustCompletedAging | FallsUnited Kingdom
-
University of FloridaCompleted
-
University Hospital, Basel, SwitzerlandCompletedCerebral PalsySwitzerland
-
Universidad Europea de MadridCompletedLumbopelvic Postpartum Pain
-
IRCCS National Neurological Institute "C. Mondino...Not yet recruitingParkinson Disease | Gait Disorders