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

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

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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