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

NCT04146675 | Completed

• 2 other identifiers: 2013_062013-A00727-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatrics

Keywords

Gerontology; elderly,; falls; balance and walking disorders.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• variation of the posturography technique

  Baseline

• variation of motion analysis (the optoelectronic system (VICON®)

  Baseline

Study Arms (2)

TRICOT JERSEY VANISE DOUBLE FACE

EXPERIMENTAL

Device: TRICOT JERSEY VANISE DOUBLE FACE

TRICOT JERSEY SIMPLE

PLACEBO COMPARATOR

Device: TRICOT JERSEY SIMPLE

Interventions

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 VANISE DOUBLE FACE

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.

TRICOT JERSEY SIMPLE

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital gériatrique les Bateliers

Lille, France

Location

Study Officials

• François Puisieux, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: October 31, 2019
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 31, 2019

Record last verified: 2019-01

Locations

FR (1)