CompletedNot Applicable

Effect of Insoles on the Postural Control of Adults

Spain31 participantsStarted 2024-03-01

Plain-language 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.

Who can participate

Age range

65 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stabilometry

Timeframe: Pre intervention, 3 months post intervention, 6 months post intervention

Trial details

NCT IDNCT06634537

SponsorUniversidad Miguel Hernandez de Elche

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More Postural; Defect trials