Falls in the Elderly
Conditions
Keywords
Fall, elderly, balance, walking, therapeutic footwear, CHUT
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.
Interventions
DEVICE"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.
Sponsors
University Hospital, Lille
INNOTHERA Laboratories
SEED at Lille University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Duration of each subject's participation: 7 days | walking speed (centimeters/seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Double support time (seconds) | Duration of each subject's participation: 7 days | Measuerd using GaitRite |
| Stride length (centimeters) | Duration of each subject's participation: 7 days | Measuerd using GaitRite |
| Stride length variability (percentage) | Duration of each subject's participation: 7 days | Measuerd using GaitRite |
| Cycle duration variability (percentage) | Duration of each subject's participation: 7 days | Measuerd using GaitRite |
| Gait asymmetry (percentage), | Duration of each subject's participation: 7 days | Measuerd using GaitRite |
| Timed Up and Go Test scores in single-task and dual-task conditions. | Duration of each subject's participation: 7 days | Higher scores mean a worse outcome |
| 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. | Duration of each subject's participation: 7 days | Shoe comfort assessed on a Likert scale from 1 to 5 on Day 1 and Day 7 |
| 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. | Duration of each subject's participation: 7 days | Ease of putting on and taking off shoes assessed on a Likert scale from 1 to 5 on Day 1 and Day |
| 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. | Duration of each subject's participation: 7 days | Feeling of stability assessed on a Likert scale from 1 to 5 on Day 1 and Day 7 |
| 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 | Duration of each subject's participation: 7 days | Feeling of security assessed on a Likert scale from 1 to 5 on Day 1 and Day7 |
Countries
France
Contacts
CONTACTFrançois PUISIEUX,, MD,PhD
Outcome results
None listed