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

NCT04146675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-31

No results posted yet for this study

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.

Conditions

  • Geriatrics

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • François Puisieux, MD, PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04146675 on ClinicalTrials.gov