NCT07366424 Evaluating the Impact of "CHUT OTONOM®" Footwear on the Spatio-temporal Parameters of Walking and the Risk of Falls in Elderly People at High Risk of Falling.
| NCT ID | NCT07366424 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Falls in the Elderly |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2027-02-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2026-02-03 with a primary completion date of 2027-02-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Footwear is one of the extrinsic factors that can cause falls in older adults. Indeed, ill-fitting or worn shoes or slippers that do not support the foot properly, have slippery soles or high heels can contribute to falls. The quality of footwear is a modifiable risk factor that must be addressed to reduce the risk of falling. Therefore, examining the feet and assessing footwear are an integral part of the clinical evaluation of older adults at risk of falling, Older patients are advised to wear shoes and to limit the use of slippers or slipper socks, which do not provide adequate support for the feet and may increase the risk of falls. In this regard, in November 2020, the French National Authority for Health (HAS) published best practice recommendations entitled "The feet of older people: medical approach and podiatric care." INNOTHERA Laboratories recently designed a new line of shoes, called CHUT OTONOM®, featuring a patented outsole whose effectiveness in terms of stability has been proven in healthy subjects.
Eligibility Criteria
Inclusion Criteria: * Male or female, 65 years of age or older * Having fallen at least once in the previous 6 months. * Patients whose foot morphology corresponds to the sizes available in Innothera Laboratories' "CHUT OTONOM®" shoes (feet with increased volume). * Patients able to walk 10 meters unaided, without technical or human assistance. * Patients seen at the "Multidisciplinary Fall Assessment" day hospital at Calmette Hospital, Lille University Hospital. * Patients who have given their consent to participate in the study (written consent form signed). * Patients affiliated to a social health insurance scheme (beneficiaries or dependents). Exclusion Criteria: * Presence of a focal motor deficit in the lower limbs from neurological or orthopedic causes (e.g., hemiplegia resulting from a stroke, limb amputation, etc.). * Inability to give informed consent * Persons under legal protection (guardianship, curatorship, judicial protection)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07366424 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Falls in the Elderly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07366424 currently recruiting?
Yes, NCT07366424 is actively recruiting participants. Contact the research team at francois.puisieux@chru-lille.fr for enrollment information.
Where is the NCT07366424 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT07366424 clinical trial?
NCT07366424 is sponsored by University Hospital, Lille. The trial plans to enroll 94 participants.