A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference of adapted movement (in term of pressure) between the A and B groups.
研究概览
简要总结
Will the use of sensory substitution by lingual electric stimulation improve in a suitable way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin interface in order to prevent the formation of pressure ulcer? We will try to demonstrate that paraplegic subject move in an appropriate matter, in term of pressure, after a movement way advised by periodical electric stimuli on the tongue.
详细描述
The objective of this study will be, to validate or not, the possibility to inform, in a suitable way, paraplegic subject by a lingual electric stimulation.
Two A and B study groups of paraplegic subjects will be built-up in a randomized way. Under standardized conditions, the A study group subject will modify his usual behavior by using the cosmetically acceptable interface to get back information for moving his chest in a suitable way in order to correct identified maxima of pressure at the seat/skin interface. Under the same conditions but without the developed device, the B study group subject will have an usual behavior.
The analysis of the different behavior in these two groups will enable to evaluate, in an objective way, the potential interest of this new medical device for the prevention of pressure ulcer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient affiliated to social security or similarly regime
- •paraplegic medullary patient
- •more or equal than 18 years old.
排除标准
- •patients will be excluded if at least one of the following criteria is present :
- •pregnancy and feeding women
- •persons without liberty by administrative or judiciary decision
- •persons hospitalized without consent
- •persons concerned by a justice protection action
- •dependant major person
- •palatine prosthesis intolerance
- •buttock pressure ulcer evolution
- •acute pathology (particularly mouth level)
- •nickel allergy
- •impossibility to use the medical device, to understand or realize the protocol due to cognitive pathologies.
- •patient with dental troubles incompatible with the realisation or utilisation of orthodontic prothesis.
- •no tactile feeling with tongue,
- •impossibility to set up the orthodontic prothesis due to superior limb deterioration
结局指标
主要结局
Difference of adapted movement (in term of pressure) between the A and B groups.
时间窗: 3 weeks
次要结局
- Qualitative and quantitative knowledge evaluation(3 weeks)
- Qualitative medical device evaluation(3 weeks)
- Adverse event collection(3 weeks)