Effect of Insoles on the Postural Control of Adults

Miguel Hernández University of Elche

Status: Completed

Conditions: Orthopedic; Adult; Postural; Defect

Treatments: Device: Active Comparator: insoles hard, soft and barefoot

Study type: Interventional

Funder types: Other

Identifiers

NCT06634537

23/604-E

Details and patient eligibility

About

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.

Full 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

Enrollment: 31 patients

Sex: All

Ages: 65 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 3 patient groups

Active Comparator: Insoles soft and hard and barefoot

Experimental group

Description:

Experimental: Active Comparator: Insoles soft The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Insoles hard and barefoot en 3 month and 6 month.

Treatment:

Device: Active Comparator: insoles hard, soft and barefoot

Active Comparator: Insoles hard and soft and barefoot

Experimental group

Description:

Experimental: Active Comparator: Insoles hard The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Insoles hard and barefoot en 3 month and 6 month.

Treatment:

Device: Active Comparator: insoles hard, soft and barefoot

Active Comparator: barefoot and insoles hard and soft

Experimental group

Description:

Experimental: Active Comparator: barefoot The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Insoles hard and barefoot en 3 month and 6 month.

Treatment:

Device: Active Comparator: insoles hard, soft and barefoot