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Evaluation of a T-shirt "Balance" Containing Ceramic Fibers

NCT ID: NCT04146675

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Geriatrics

Keywords

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Gerontology elderly, falls balance and walking disorders.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TRICOT JERSEY VANISE DOUBLE FACE

Group Type EXPERIMENTAL

TRICOT JERSEY VANISE DOUBLE FACE

Intervention Type 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.

TRICOT JERSEY SIMPLE

Group Type PLACEBO_COMPARATOR

TRICOT JERSEY SIMPLE

Intervention Type 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.

Interventions

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TRICOT JERSEY VANISE DOUBLE FACE

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.

Intervention Type DEVICE

TRICOT JERSEY SIMPLE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Puisieux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital gériatrique les Bateliers

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2013-A00727-38

Identifier Type: OTHER

Identifier Source: secondary_id

2013_06

Identifier Type: -

Identifier Source: org_study_id