Pilot Study for the Evaluation of a T-shirt "Balance" Containing Ceramic Fibers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Variation of the Tinetti score between the two group
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TRICOT JERSEY VANISE DOUBLE FACE
干预措施: TRICOT JERSEY VANISE DOUBLE FACE (Device)
TRICOT JERSEY SIMPLE
干预措施: TRICOT JERSEY SIMPLE (Device)
结局指标
主要结局
Variation of the Tinetti score between the two group
时间窗: 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.
次要结局
- variation of the posturography technique(Baseline)
- variation of motion analysis (the optoelectronic system (VICON®)(Baseline)