Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
31 participants
INTERVENTIONAL
2024-03-01
2024-10-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Comparator: Insoles soft and hard and barefoot
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.
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 \[Time Frame: pre intervention, 3 months post intervention, 6 months post intervention\]
Active Comparator: Insoles hard and soft and barefoot
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.
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 \[Time Frame: pre intervention, 3 months post intervention, 6 months post intervention\]
Active Comparator: barefoot and insoles hard and soft
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.
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 \[Time Frame: pre intervention, 3 months post intervention, 6 months post intervention\]
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 \[Time Frame: pre intervention, 3 months post intervention, 6 months post intervention\]
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
65 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Miguel Hernandez de Elche
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vicenta Martínez Córcoles
Principal Investigator PhD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidad Miguel Hernández de Elche
Elche, Alicante, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23/604-E
Identifier Type: -
Identifier Source: org_study_id