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Sponsors and Collaborators: |
University Hospital, Grenoble Centre Medico Universitaire Daniel Douady (CMUDD) GMCAO team of TIMC-IMAG-CNRS laboratory |
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Information provided by: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00429013 |
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.
Condition | Intervention | Phase |
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Paraplegia |
Device: Tongue Display Unit |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent. |
Estimated Enrollment: | 24 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | April 2007 |
The objective of this study will be, to validate or not, the possibility to inform, in a suitable way, paraplegic subject by an 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
patients will be excluded if at least one of the following criteria is present :
Contact: Alexandre Moreau-Gaudry, Ph.D M.D. | 33476765040 | Alexandre.Moreau-Gaudry@imag.fr |
France, CEDEX 09 | |
University Hospital of Grenoble | Recruiting |
GRENOBLE, CEDEX 09, France, 38043 | |
Sub-Investigator: Anne Prince, M.D. | |
Sub-Investigator: Thomas Fortin, M.D. Ph.D. | |
Sub-Investigator: Marc Hommel, M.D. | |
Sub-Investigator: Wilfried Vadot, M.D. |
Principal Investigator: | Alexandre Moreau-Gaudry, Ph.D. M.D. | University Hospital, Grenoble |
Study ID Numbers: | DCIC-05-44 |
Study First Received: | January 29, 2007 |
Last Updated: | January 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00429013 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Pressure ulcer Lingual electric stimulation Paraplegic patient Pressure Ulcer/Prevention & control |
Paralysis Signs and Symptoms Skin Diseases Ulcer |
Paraplegia Neurologic Manifestations Skin Ulcer Pressure Ulcer |
Nervous System Diseases |