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Not Yet RecruitingNCT07366424

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.

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
94 (estimated)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICE"CHUT OTONOM®" shoes from Innothera LaboratoriesThe patient will be asked to put on, depending on the group to which they have been randomized, Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories to perform the Timed Up and Go (TUG) test, the one-leg balance test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the same measurements will then be taken with their usual shoes.
DEVICE"CHUT OTONOM®" shoes from Innothera LaboratoriesThe patient will be asked to put on, depending on the group to which they have been randomized, Sequence 2: "Their usual shoes to perform the TUG, the one-leg stand test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the same measurements will then be taken with the "CHUT OTONOM®" shoes from Innothera Laboratories

Timeline

Start date
2026-01-31
Primary completion
2027-02-07
Completion
2027-02-07
First posted
2026-01-26
Last updated
2026-01-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07366424. Inclusion in this directory is not an endorsement.