Status:
TERMINATED
Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Centre Medico Universitaire Daniel Douady (CMUDD)
TIMC-IMAG
Conditions:
PARAPLEGIA
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 sub...
Eligibility Criteria
Inclusion
- patient affiliated to social security or similarly regime
- paraplegic medullary patient
- more or equal than 18 years old.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00429013
Start Date
September 1 2006
End Date
March 1 2009
Last Update
September 15 2016
Active Locations (1)
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1
University Hospital of Grenoble
Grenoble, Cedex 09, France, 38043