Clinical trial NCT05319626: Immediate Effects of Two Different Lower Limb Sensory Stimulation Strategies on Balance and Mobility in Older Adults
Official title: Immediate Effects of Two Different Lower Limb Sensory Stimulation Strategies on Balance and Mobility in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Balance
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Foot sensation test
timeFrame: in an average of one and half hour
measure: Balance test
timeFrame: in an average of one and half hour
measure: Mobility test
timeFrame: in an average of one and half hour
Secondary outcomes:
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Gazi University, Faculty of Health Sciences
state: Ankara
Study officials:
affiliation: Gazi University
name: Sevim Beyza Ölmez
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Selda Başar
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Tuğçe Çoban
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.