Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.

Conditions
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PARAPLEGIA

Intervention / Treatment
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* Device: Tongue Display Unit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient affiliated to social security or similarly regime paraplegic medullary patient more or equal than 18 years old. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2<br>no medical device | |
| Experimental: 1<br>medical device | Device: Tongue Display Unit<br>* lingual electric stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of adapted movement (in term of pressure) between the A and B groups. |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative and quantitative knowledge evaluation |  | 3 weeks | 
| Qualitative medical device evaluation |  | 3 weeks | 
| Adverse event collection |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcer, Lingual electric stimulation, Paraplegic patient, Pressure Ulcer/Prevention & control