NCT05319626

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

March 28, 2022

Last Update Submit

June 20, 2023

Conditions

ElderlyBalance

Outcome Measures

Primary Outcomes (3)

  • Foot sensation test

    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

    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

    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

Study Arms (4)

Intervention group 1

EXPERIMENTAL

Compression socks with Textured insoles

Other: compression socksOther: textured insoles

Intervention group 2

EXPERIMENTAL

Compression socks with Smooth insoles

Other: compression socksOther: smooth insoles

Intervention group 3

EXPERIMENTAL

Smooth socks with Textured insoles

Other: textured insolesOther: smooth socks

Control group

PLACEBO COMPARATOR

Smooth socks with Smooth insoles

Other: smooth socksOther: smooth insoles

Interventions

compression socksOTHER

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 group 1Intervention group 2
textured insolesOTHER

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 1Intervention group 3
smooth socksOTHER

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.

Also known as: control socks
Control groupIntervention group 3
smooth insolesOTHER

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.

Also known as: control insoles
Control groupIntervention group 2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Faculty of Health Sciences

Çankaya, Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28355265BACKGROUND

  • 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.

    PMID: 31022658BACKGROUND

  • 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.

    PMID: 33556067BACKGROUND

Study Officials

  • Sevim Beyza Ölmez

    Gazi University

    PRINCIPAL INVESTIGATOR

  • Selda Başar

    Gazi University

    STUDY DIRECTOR

  • Tuğçe Çoban

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 8, 2022

Study Start

October 18, 2021

Primary Completion

April 18, 2023

Study Completion

June 20, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)