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

Not Applicable

Completed

• Conditions: Geriatrics
• Interventions: Device: TRICOT JERSEY SIMPLE; Device: TRICOT JERSEY VANISE DOUBLE FACE

• Registration Number: NCT04146675
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2019-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-30
• Study First Posted: 2019-10-31
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRICOT JERSEY SIMPLE	TRICOT JERSEY SIMPLE	-
TRICOT JERSEY VANISE DOUBLE FACE	TRICOT JERSEY VANISE DOUBLE FACE	-

Primary Outcome Measures

Name	Time	Method
Variation of the Tinetti score between the two group	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 Outcome Measures

Name	Time	Method
variation of the posturography technique	Baseline	Parameters of the static equilibrium produced by the posturography technique: the length of the balancing path (mm)
variation of motion analysis (the optoelectronic system (VICON®)	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

Trial Locations

Locations (1)

Hôpital gériatrique les Bateliers; 🇫🇷 Lille, France