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.

Обзор

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.

Вмешательства

• Устройство "CHUT OTONOM®" shoes from Innothera Laboratories
  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.
• Устройство "CHUT OTONOM®" shoes from Innothera Laboratories
  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

Первичные конечные точки

• 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. [Срок оценки: Duration of each subject's participation: 7 days]

Вторичные конечные точки (10)

• Double support time (seconds) [Срок оценки: Duration of each subject's participation: 7 days]
• Stride length (centimeters) [Срок оценки: Duration of each subject's participation: 7 days]
• Stride length variability (percentage) [Срок оценки: Duration of each subject's participation: 7 days]
• Cycle duration variability (percentage) [Срок оценки: Duration of each subject's participation: 7 days]
• Gait asymmetry (percentage), [Срок оценки: Duration of each subject's participation: 7 days]
• Timed Up and Go Test scores in single-task and dual-task conditions. [Срок оценки: Duration of each subject's participation: 7 days]
• Shoe comfort will be evaluated using the following subjective ordinal scale: 1 very uncomfortable, 2 uncomfortable, 3 neutral, 4 comfortable, 5 very comfortable (according to Menant et al., 2008) on D1 and D7. [Срок оценки: Duration of each subject's participation: 7 days]
• The ease of putting on and taking off shoes will be evaluated using the following modified subjective ordinal scale (Menant et al., 2008): 1 very difficult, 2 difficult, 3 neutral, 4 easy, 5 very easy on D1 and D7. [Срок оценки: Duration of each subject's participation: 7 days]
• The feeling of stability will be evaluated using the following subjective ordinal scale (Menant et al., 2008): 1 very unstable, 2 unstable, 3 neutral, 4 stable, 5 very stable on D1 and D7. [Срок оценки: Duration of each subject's participation: 7 days]
• The feeling of security will be evaluated using the following subjective ordinal scale (Menant et al., 2008): 1 always, 2 often, 3 sometimes, 4 rarely, 5 never on D1 and D7 [Срок оценки: Duration of each subject's participation: 7 days]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• CHU de Lille — Lille

Идентификаторы

NCT: NCT07366424 · 2024_0604

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗