NCT06634537

Effect of Insoles on the Postural Control of Adults

Effect of Hard and Soft Density Insoles on the Postural Control of Adults Over 65 Years of Age

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Universidad Miguel Hernandez de Elche · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Accepted

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

Conditions

• Postural; Defect
• Adult
• Orthopedic

Interventions

Type	Name	Description
DEVICE	Active Comparator: insoles hard, soft and barefoot	Primary Outcome Measure: 1\. Stabilometry The measurements were conducted University. To assess participants' balance, the anthropometric position of the protocol proposed by the International Society for the Advancement of Cineatropometry (ISAK) was assigned: participants placed their mi Frankfort; the upper limbs remained relaxed throughout the body, with palms facing forward and thumbs separated from the rest of the toes, and were barefoot with feet externally rotated f 30 degrees and with a heel distance of 4cm. The children were wearing sports costumes to contribute their free movement. For stabilometry data collection will use an inertial measurement instrument called Gyko® It is a state-of-the-art device that allows to measure an objective assessment of acceleration, angular velocity and with an acquisition frequency of 100Hz \[Time Frame: pre intervention, 3 months post intervention, 6 months post intervention\]

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-10-01
• Completion: 2024-10-14
• First posted: 2024-10-10
• Last updated: 2024-12-02

Locations

1 site across 1 country: Spain