Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.|
- Difference of adapted movement (in term of pressure) between the A and B groups. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Qualitative and quantitative knowledge evaluation [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Qualitative medical device evaluation [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Adverse event collection [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2006|
|Study Completion Date:||March 2009|
|Estimated Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
No Intervention: 2
no medical device
Device: Tongue Display Unit
lingual electric stimulation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429013
|University Hospital of Grenoble|
|Grenoble, Cedex 09, France, 38043|
|Principal Investigator:||Alexandre Moreau-Gaudry, Ph.D. M.D.||University Hospital, Grenoble|