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

G

Gazi University

Status

Completed

Conditions

Balance
Elderly

Treatments

Other: smooth insoles
Other: smooth socks
Other: compression socks
Other: textured insoles

Study type

Interventional

Funder types

Other

Identifiers

NCT05319626
2021-844

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

24 participants in 4 patient groups, including a placebo group

Intervention group 1
Experimental group
Description:
Compression socks with Textured insoles
Treatment:
Other: textured insoles
Other: compression socks
Intervention group 2
Experimental group
Description:
Compression socks with Smooth insoles
Treatment:
Other: compression socks
Other: smooth insoles
Intervention group 3
Experimental group
Description:
Smooth socks with Textured insoles
Treatment:
Other: textured insoles
Other: smooth socks
Control group
Placebo Comparator group
Description:
Smooth socks with Smooth insoles
Treatment:
Other: smooth socks
Other: smooth insoles

Trial contacts and locations

1

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Central trial contact

Sevim Beyza Ölmez

Data sourced from clinicaltrials.gov

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