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

Sponsor
Gazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05319626
Collaborator
(none)
24
1
4
13.4
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: compression socks
  • Other: textured insoles
  • Other: smooth socks
  • Other: smooth insoles
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Immediate Effects of Two Different Lower Limb Sensory Stimulation Strategies on Balance and Mobility in Older Adults
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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 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
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. Foot sensation test [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.

    2. Balance test [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.

    3. Mobility test [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University, Faculty of Health Sciences Çankaya Ankara Turkey 06490

    Sponsors and Collaborators

    • Gazi University

    Investigators

    • Principal Investigator: Sevim Beyza Ölmez, Gazi University
    • Study Director: Selda Başar, Gazi University
    • Principal Investigator: Tuğçe Çoban, Gazi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sevim Beyza Ölmez, Principal Investigator, Gazi University
    ClinicalTrials.gov Identifier:
    NCT05319626
    Other Study ID Numbers:
    • 2021-844
    First Posted:
    Apr 8, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 23, 2022