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

NCT ID: NCT05319626

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2023-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elderly Balance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group 1

Compression socks with Textured insoles

Group Type EXPERIMENTAL

compression socks

Intervention Type OTHER

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.

textured insoles

Intervention Type OTHER

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.

Intervention group 2

Compression socks with Smooth insoles

Group Type EXPERIMENTAL

compression socks

Intervention Type OTHER

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.

smooth insoles

Intervention Type OTHER

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.

Intervention group 3

Smooth socks with Textured insoles

Group Type EXPERIMENTAL

textured insoles

Intervention Type OTHER

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.

smooth socks

Intervention Type OTHER

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.

Control group

Smooth socks with Smooth insoles

Group Type PLACEBO_COMPARATOR

smooth socks

Intervention Type OTHER

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.

smooth insoles

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

control socks control insoles

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gazi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sevim Beyza Ölmez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sevim Beyza Ölmez

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Selda Başar

Role: STUDY_DIRECTOR

Gazi University

Tuğçe Çoban

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gazi University, Faculty of Health Sciences

Çankaya, Ankara, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Woo MT, Davids K, Liukkonen J, Orth D, Chow JY, Jaakkola T. Effects of different lower-limb sensory stimulation strategies on postural regulation-A systematic review and meta-analysis. PLoS One. 2017 Mar 29;12(3):e0174522. doi: 10.1371/journal.pone.0174522. eCollection 2017.

Reference Type BACKGROUND
PMID: 28355265 (View on PubMed)

Kenny RPW, Atkinson G, Eaves DL, Martin D, Burn N, Dixon J. The effects of textured materials on static balance in healthy young and older adults: A systematic review with meta-analysis. Gait Posture. 2019 Jun;71:79-86. doi: 10.1016/j.gaitpost.2019.04.017. Epub 2019 Apr 17.

Reference Type BACKGROUND
PMID: 31022658 (View on PubMed)

Woo MT, Davids K, Chow JY, Jaakkola T. Acute effects of wearing compression knee-length socks on ankle joint position sense in community-dwelling older adults. PLoS One. 2021 Feb 8;16(2):e0245979. doi: 10.1371/journal.pone.0245979. eCollection 2021.

Reference Type BACKGROUND
PMID: 33556067 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-844

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.