Clinical trial NCT00429013: Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
Official title: A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: PARAPLEGIA
Keywords: Pressure ulcer
Lingual electric stimulation
Paraplegic patient
Pressure Ulcer/Prevention & control
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Centre Medico Universitaire Daniel Douady (CMUDD)
name: TIMC-IMAG
First posted: 2007-01-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference of adapted movement (in term of pressure) between the A and B groups.
timeFrame: 3 weeks
Secondary outcomes:
measure: Qualitative and quantitative knowledge evaluation
timeFrame: 3 weeks
measure: Qualitative medical device evaluation
timeFrame: 3 weeks
measure: Adverse event collection
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
state: Cedex 09
Study officials:
affiliation: University Hospital, Grenoble
name: Alexandre Moreau-Gaudry, Ph.D. M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moreau-Gaudry A, Prince A, Demongeot J, Payan Y. A new health strategy to prevent pressure ulcer formation in paraplegics using computer and sensory substitution via the tongue. Stud Health Technol Inform. 2006;124:926-31.