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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00727-38 | Other Identifier | ID-RCB number, ANSM |
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Falls are frequent and often serious events in the elderly. The consequences of falls are often severe: traumatic (fractures, hematomas, ..) and psychological. Falls are among the top ten causes of death in this population and, for people older than 70, falls are the leading cause of accidental death.
The Damart company has developed a fabric containing ceramic fibers. Clothes containing such fibers have been found to improve balance.
This study aims to measure the effect of a t-shirt with a ceramic membrane ("ceramic" t-shirt) on the balance and walking compared to the effect of a "placebo" t-shirt (same weight, appearance and texture).
The hypothesis is that wearing the ceramic tee-shirt significantly improves balance and walking, suggesting that it can also reduce falls - the main consequence of the balance and walking disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRICOT JERSEY VANISE DOUBLE FACE | Experimental |
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| TRICOT JERSEY SIMPLE | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRICOT JERSEY VANISE DOUBLE FACE | Device | Short sleeve t-shirt : TRICOT JERSEY VANISE DOUBLE FACE " THERMOLACTYL EVOLUTION " with ceramic fibers. A Tinetti test will be performed while wearing the T-shirt, as well as an evaluation of the equilibration on posturography platform under static conditions and an assessment of dynamic equilibrium and locomotion in motion analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the Tinetti score between the two group | Variation of the Tinetti score between the group T-shirt placebo (Δ Tinetti T-shirt placebo vs Tinetti clothing patients) and the ceramic tee-shirt group (Δ Tinetti ceramic t-shirt vs Tinetti clothing patients). Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| variation of the posturography technique | Parameters of the static equilibrium produced by the posturography technique: the length of the balancing path (mm) | Baseline |
| variation of motion analysis (the optoelectronic system (VICON®) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Puisieux, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital gériatrique les Bateliers | Lille | France |
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| TRICOT JERSEY SIMPLE | Device | Short sleeve t-shirt : TRICOT JERSEY SIMPLE The comparator T-shirt has the same weight, the same appearance, and will be used by patients in the same way and under the same conditions as the T-shirt with ceramic fibers. |
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Parameters of the dynamic equilibrium and locomotion produced by the technique of motion analysis.
Analysis of gait parameters: speed (seconde) and length (meters). these parameters will be combined to report the dynamic equilibrium and locomotion
| Baseline |