Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634537
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Effect of Insoles on the Postural Control of Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Hard and Soft Density Insoles on the Postural Control of Adults Over 65 Years of Age
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 6903382 years Postural control willevaluated in different conditions of barefoot balance with hard and soft 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 6903382 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 httpswwwsidascomesplantillas-para-el-uso-diario156-cushioning-gelhtml During the third and final test Winter insoles were used SIDAS 18 rue Léon Béridot Voiron France httpswwwsidascomesplantillas-esqui-snowboard221-winter-plushtml
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
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 httpswwwsidascomesplantillas-para-el-uso-diario156-cushioning-gelhtml During the third and final test Winter insoles were used SIDAS 18 rue Léon Béridot Voiron France httpswwwsidascomesplantillas-esqui-snowboard221-winter-plushtml
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None