Evaluation of a T-shirt "Balance" Containing Ceramic Fibers (Equi-tee-shirt)

University Hospital, Lille

Status: Completed

Conditions: Geriatrics

Treatments: Device: TRICOT JERSEY VANISE DOUBLE FACE; Device: TRICOT JERSEY SIMPLE

Study type: Interventional

Funder types: Other

Identifiers

NCT04146675

2013_06

2013-A00727-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

TRICOT JERSEY VANISE DOUBLE FACE

Experimental group

Treatment:

Device: TRICOT JERSEY VANISE DOUBLE FACE

TRICOT JERSEY SIMPLE

Placebo Comparator group

Treatment:

Device: TRICOT JERSEY SIMPLE