Clinical trial NCT06634537: Effect of Insoles on the Postural Control of Adults
Official title: Effect of Hard and Soft Density Insoles on the Postural Control of Adults Over 65 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural; Defect
Adult
Orthopedic
Keywords: BALANCE
insoles
barefoot
olders adults
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal
Primary purpose: PREVENTION

Brief summary: Background: there is a high risk of falls in older adults. One of the factors contributing to fall episodes is advancing age due to deterioration of the proprioceptive system. Certain clinical procedures improve balance and posture such as the use of insoles.

Objetive: to evaluate the impact of hard and soft insoles on static foot balance in healthy older adults compared to barefoot people.

Methods: a clinical trial was conducted with a sample size of 31 healthy with a mean age of 69.03±3.82 years. Postural control willevaluated in different conditions of barefoot balance with hard and soft insoles.

Detailed description: All subjects completed three testing sessions in a laboratory setting without external distraction. The same testing procedures were repeated during each session, with a time period of one week between sessions. All participants were asked for their information (age, sex, weight, height and date of birth), and they were then asked to take off their shoes in order to take the measurements. The Gyko® device was then placed in a harness on the back of the participant, who was subsequently asked to remain in an anthropometric position.

During the first testing session, postural impacts were assessed whilst subjects will barefoot. In the second testing session, subjects wore a soft gel insole: Cushioning gel slim (SIDAS, 18, rue Léon Béridot, Voiron, France: https://www.sidas.com/es/plantillas-para-el-uso-diario/156-cushioning-gel.html). During the third and final test, Winter+ insoles were used (SIDAS, 18, rue Léon Béridot, Voiron, France; https://www.sidas.com/es/plantillas-esqui-snowboard/221-winter-plus.html) .

Each session lasted around 30 seconds, data will collected while standing, with participants in in a bilateral stance. Each task was performed both with eyes open and eyes closed. To control for possible variations in visual field, subjects were asked to focus on a target placed 2 meters in front of them at eye level. If the person moved or lost balance, the data was discarded and the test was repeated until it was obtained correctly.

In each test, the data was managed as follows; the first 10 seconds of each test were discarded; the average of the remaining 20 seconds was taken for later analysis. Postural sway was assessed using a set of measures. The sway area (cm2) will calculated using the area of the ellipse generated by the software. Additionally, sway distance and sway velocity were assessed along the anterior-posterior and medial-lateral axes

Eligibility criteria: Inclusion Criteria:

* The insoles involved are standard insoles which are not used to correct deformities; the differences between them concern the density of the materials (higher density is harder and lower density is softer). Participants could have any existing foot condition or deformity.
* Each pre-existing foot condition or deformity would be noted and listed for the sole purpose of evaluating the relationship between postural control and said deformity,
* have reached or are over 65 years of age,
* present with normal or corrected vision,
* capable of walking independently without the use of an assistive device, since the use of technical aids masks the potential effects of the insole.

Exclusion Criteria:

* present with a current injury, or injury 6 months prior to the test, in the lower limb,
* Suffer from a musculoskeletal disorder,
* present with uncorrected vision,
* are pregnant,
* experience neurological disorders, diabetes or lower limb amputation/prosthetics, plantar ulcers, or cognitive impairment

Primary outcomes:
measure: Stabilometry
timeFrame: Pre intervention, 3 months post intervention, 6 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Universidad Miguel Hernández de Elche
state: Alicante
Study officials:
References:
citation: Hertel J, Sloss BR, Earl JE. Effect of foot orthotics on quadriceps and gluteus medius electromyographic activity during selected exercises. Arch Phys Med Rehabil. 2005 Jan;86(1):26-30. doi: 10.1016/j.apmr.2004.03.029.
citation: Hatton AL, Dixon J, Martin D, Rome K. The effect of textured surfaces on postural stability and lower limb muscle activity. J Electromyogr Kinesiol. 2009 Oct;19(5):957-64. doi: 10.1016/j.jelekin.2008.04.012. Epub 2008 Jun 18.
citation: Kulig K, Burnfield JM, Reischl S, Requejo SM, Blanco CE, Thordarson DB. Effect of foot orthoses on tibialis posterior activation in persons with pes planus. Med Sci Sports Exerc. 2005 Jan;37(1):24-9. doi: 10.1249/01.mss.0000150073.30017.46.