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| Name | Class |
|---|---|
| INNOTHERA Laboratories | UNKNOWN |
| SEED at Lille University Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: "CHUT OTONOM®" shoes from Innothera Laboratories | Experimental | 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. |
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| Sequence 2: Their usual shoes to perform the TUG | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "CHUT OTONOM®" shoes from Innothera Laboratories | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Duration of each subject's participation: 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Double support time (seconds) | Measuerd using GaitRite | Duration of each subject's participation: 7 days |
| Stride length (centimeters) | Measuerd using GaitRite |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François PUISIEUX,, MD,PhD | Contact | 03.20.44.46.80 | francois.puisieux@chru-lille.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille | Recruiting | Lille | France |
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| "CHUT OTONOM®" shoes from Innothera Laboratories | Device | 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 |
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| Duration of each subject's participation: 7 days |
| Stride length variability (percentage) | Measuerd using GaitRite | Duration of each subject's participation: 7 days |
| Cycle duration variability (percentage) | Measuerd using GaitRite | Duration of each subject's participation: 7 days |
| Gait asymmetry (percentage), | Measuerd using GaitRite | Duration of each subject's participation: 7 days |
| Timed Up and Go Test scores in single-task and dual-task conditions. | Higher scores mean a worse outcome | 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. | Shoe comfort assessed on a Likert scale from 1 to 5 on Day 1 and Day 7 | 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. | Ease of putting on and taking off shoes assessed on a Likert scale from 1 to 5 on Day 1 and Day | 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. | Feeling of stability assessed on a Likert scale from 1 to 5 on Day 1 and Day 7 | 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 | Feeling of security assessed on a Likert scale from 1 to 5 on Day 1 and Day7 | Duration of each subject's participation: 7 days |