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

June 20, 2023 updated by: Sevim Beyza Ölmez, Gazi University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Ankara
      • Çankaya, Ankara, Turkey, 06490
        • Gazi University, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group 1
Compression socks with Textured insoles
Other: compression socks
The compression socks have a clinical pressure of 23-30 mm Hg. The socks are dressed to the participants based on the manufacturer's sizing guidelines.
Other: textured insoles
The textured insoles have small, pyramidal peaks with centre-to-centre distances of approximately 2.5 mm (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe.
Experimental: Intervention group 2
Compression socks with Smooth insoles
Other: compression socks
The compression socks have a clinical pressure of 23-30 mm Hg. The socks are dressed to the participants based on the manufacturer's sizing guidelines.
Other: smooth insoles
The smooth insoles have a completely flat surface (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe.
Other Names:
  • control insoles
Experimental: Intervention group 3
Smooth socks with Textured insoles
Other: textured insoles
The textured insoles have small, pyramidal peaks with centre-to-centre distances of approximately 2.5 mm (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe.
Other: smooth socks
The smooth socks are a commercial stocking that does not have a compression feature, but has a similar thickness and color to the compression stocking. They have standard size.
Other Names:
  • control socks
Placebo Comparator: Control group
Smooth socks with Smooth insoles
Other: smooth insoles
The smooth insoles have a completely flat surface (Evalite Pyramid EVA, 3 mm thickness, shore value A50, black). The insoles cut to a range of men's and women's standard EU shoe sizes. During the testing process, they are worn within a standardised shoe.
Other Names:
  • control insoles
Other: smooth socks
The smooth socks are a commercial stocking that does not have a compression feature, but has a similar thickness and color to the compression stocking. They have standard size.
Other Names:
  • control socks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Foot sensation test
Time Frame: 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.
in an average of one and half hour
Balance test
Time Frame: 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.
in an average of one and half hour
Mobility test
Time Frame: 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.
in an average of one and half hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sevim Beyza Ölmez, Gazi University
  • Study Director: Selda Başar, Gazi University
  • Principal Investigator: Tuğçe Çoban, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-844

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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