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

Pilot Study for the 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.

Study Overview

• Status: Completed
• Conditions: Geriatrics
• Intervention / Treatment: Device: TRICOT JERSEY VANISE DOUBLE FACE; Device: TRICOT JERSEY SIMPLE

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital gériatrique les Bateliers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRICOT JERSEY VANISE DOUBLE FACE	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.
Placebo Comparator: TRICOT JERSEY SIMPLE	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of the Tinetti score between the two group	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.	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: François Puisieux, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: falls; Gerontology; elderly,; balance and walking disorders.
• Other Study ID Numbers: 2013_06; 2013-A00727-38 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No