Effect of Hard and Soft Density Insoles on the Postural Control of Adults Over 65 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Stabilometry
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Stabilometry
时间窗: Pre intervention, 3 months post intervention, 6 months post intervention
To evaluate balance, participants were instructed to maintain the protocol anthropometric position proposed by the International Society for the Advancement of Kinanthropometry (ISAK); participants positioned their head on the Frankfort plane, with their upper limbs in a relaxed position, palms facing forward, and thumbs separated from the rest of their fingers. Participants were required to stand barefoot, with feet externally rotated at 30 degrees and a distance of 4 cm between both heels. A Gyko inertial sensor system was used to collect the balance data (i.e. ellipse area (EA): length and surface area in cm2). The software automatically calculates the length and surface projection, the velocity projection and the frequency of oscillations. The Gyko system offers high reliability in measuring postural control compared to other measurement systems . Previous research has shown that this protocol had moderate to strong evidence of validity and reliability.
次要结局
未报告次要终点
研究者
Vicenta Martínez Córcoles
Principal Investigator PhD
Universidad Miguel Hernandez de Elche