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.

N/ANot Yet RecruitingNCT07366424

University Hospital, Lille94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Falls in the Elderly

Interventions

The 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.

"CHUT OTONOM®" shoes from Innothera LaboratoriesDEVICE

The 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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Measurement of walking speed (cm/s) using the GaitRite device under two conditions: with Innothera Laboratories' CHUT OTONOM® shoes and with the patient's usual shoes.

walking speed (centimeters/seconds)