The Balance and Foot Health Program for Older Adults: A Randomized Study (NCT07758764) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Balance and Foot Health Program for Older Adults: A Randomized Study
France200 participantsStarted 2026-09-01
Plain-language summary
Every year in France, 2 million falls by people over 65 are responsible for 10,000 deaths, the leading cause of accidental death, and more than 130,000 hospitalizations. The primary objective of this study is to compare the effectiveness of adding 12 weekly foot health workshops to balance workshops on mobility among older adults living in nursing homes, compared to a program based exclusively on balance workshops.
Who can participate
Age range
65 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:
* People aged 65 and older.
* Residents of nursing homes.
* Able to walk, with or without a walking aid (cane, walker, etc.)
* Residents at risk of falling, defined by at least one of the following criteria: history of a fall within the last 12 months; unsteadiness while walking or balance issues; limited mobility.
* Able to understand and follow simple instructions.
* Able to participate in workshops.
* Enrolled in a social security program or beneficiaries of an equivalent program.
* Individuals (participants, guardians, or conservators, as applicable) who have been informed and have provided written consent for their participation in the study.
Exclusion Criteria:
\- Regular use of minimalist shoes at the time of enrollment.
* Medical condition or clinical situation contraindicating the use of minimalist shoes, as determined by the investigator.
* Use of orthopedic shoes prescribed by a healthcare professional.
* Unhealed foot wound or active foot infection.
* Recent lower limb fracture (\< 3 months) or recent lower limb trauma, likely to limit participation in the workshops or contraindicate foot mobilization, as assessed by the investigator.
* Severe cognitive impairment preventing the understanding of simple instructions or participation in the workshops.
* Any other clinical condition deemed incompatible with participation in the study by the investigator.
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
1
The change in the Timed Up and Go test time, expressed in seconds
Timeframe: at baseline assessment (T0) and after the 12 intervention sessions (T1)