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. (CHAUSS-THERA)

University Hospital, Lille

Status: Not yet enrolling

Conditions: Falls in the Elderly

Treatments: Device: "CHUT OTONOM®" shoes from Innothera Laboratories

Study type: Interventional

Funder types: Other

Identifiers

NCT07366424

2024_0604

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

94 participants in 2 patient groups

Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories

Experimental group

Description:

Once the patient has agreed to participate, they will be asked to put on, depending on their randomization arm (sequence): Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories to perform the TUG, the one-leg stand test, and the treadmill recording (GaitRite) for 5 minutes. After a 15-minute rest period, the measurements will then be taken with their usual shoes.

Treatment:

Device: "CHUT OTONOM®" shoes from Innothera Laboratories

Device: "CHUT OTONOM®" shoes from Innothera Laboratories

Sequence 2: Their usual shoes to perform the TUG

Active Comparator group

Description:

Once the patient has agreed to participate, they will be asked to put on, depending on their randomization arm (sequence): 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 measurements will then be taken with the "CHUT OTONOM®" shoes from Innothera Laboratories

Treatment:

Device: "CHUT OTONOM®" shoes from Innothera Laboratories

Device: "CHUT OTONOM®" shoes from Innothera Laboratories