Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
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 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.
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 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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Paraplegia
Intervention
Tongue Display Unit
Location
University Hospital of Grenoble
Grenoble
Cedex 09
France
38043
Status
Terminated
Source
University Hospital, Grenoble
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00429013
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Data Display
The visual display of data in a man-machine system. An example is when data is called from the computer and transmitted to a CATHODE RAY TUBE DISPLAY or LIQUID CRYSTAL display.
Tongue, Hairy
A benign condition of the tongue characterized by hypertrophy of the filiform papillae that give the dorsum of the tongue a furry appearance. The color of the elongated papillae varies from yellowish white to brown or black, depending upon staining by substances such as tobacco, food, or drugs. (Dorland, 27th ed)
Tongue Habits
Acquired responses regularly manifested by tongue movement or positioning.
Tongue Neoplasms
Tumors or cancer of the TONGUE.
Spastic Paraplegia, Hereditary
A group of inherited diseases that share similar phenotypes but are genetically diverse. Different genetic loci for autosomal recessive, autosomal dominant, and x-linked forms of hereditary spastic paraplegia have been identified. Clinically, patients present with slowly progressive distal limb weakness and lower extremity spasticity. Peripheral sensory neurons may be affected in the later stages of the disease. (J Neurol Neurosurg Psychiatry 1998 Jan;64(1):61-6; Curr Opin Neurol 1997 Aug;10(4):313-8)
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