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Completed

NCT Number: NCT04146675

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

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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Key information

Conditions

Geriatrics

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital gériatrique les Bateliers

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Variation of the Tinetti score between the two group

    Time frame: Baseline

    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.

Secondary outcomes

  1. variation of the posturography technique

    Time frame: Baseline

    Parameters of the static equilibrium produced by the posturography technique: the length of the balancing path (mm)

  2. variation of motion analysis (the optoelectronic system (VICON®)

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: Equi-tee-shirt

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2019
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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