Evaluation of a T-shirt Balance Containing Ceramic Fibers

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Pilot Study for the Evaluation of a T-shirt Balance Containing Ceramic Fibers

Conditions
-----------------
Geriatrics

Intervention / Treatment
-----------------
* Device: TRICOT JERSEY VANISE DOUBLE FACE
* Device: TRICOT JERSEY SIMPLE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting disturbances of balance (determined by a Tinetti test score strictly greater than 12) Hold the balance while standing with his feet and arms along the body and walk for 3 meters without major imbalance that may cause a fall Consent to participate in the study (a signed written consent form) Covered by a social security system Exclusion Criteria: A motor deficit of the lower limbs focused and characterized by neurological or orthopedic cause (for example hemiplegia after a cerebrovascular accident, limb amputation). Inability to receive the protocol information Inability to participate in the entire study Absence of a social security coverage Refusal to sign the Informed Consent form

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRICOT JERSEY VANISE DOUBLE FACE<br> | Device: TRICOT JERSEY VANISE DOUBLE FACE<br>* 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.<br>|
| Placebo Comparator: TRICOT JERSEY SIMPLE<br> | Device: TRICOT JERSEY SIMPLE<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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®) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gerontology, elderly,, falls, balance and walking disorders.