Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
|ClinicalTrials.gov Identifier: NCT00429013|
Recruitment Status : Terminated (principal criteria was achieved with the intermediate statistical analysis)
First Posted : January 30, 2007
Last Update Posted : September 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|PARAPLEGIA||Device: Tongue Display Unit||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.|
|Study Start Date :||September 2006|
|Primary Completion Date :||January 2009|
|Study Completion Date :||March 2009|
No Intervention: 2
no medical device
Device: Tongue Display Unit
lingual electric stimulation
- Difference of adapted movement (in term of pressure) between the A and B groups. [ Time Frame: 3 weeks ]
- Qualitative and quantitative knowledge evaluation [ Time Frame: 3 weeks ]
- Qualitative medical device evaluation [ Time Frame: 3 weeks ]
- Adverse event collection [ Time Frame: 3 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429013
|University Hospital of Grenoble|
|Grenoble, Cedex 09, France, 38043|
|Principal Investigator:||Alexandre Moreau-Gaudry, Ph.D. M.D.||University Hospital, Grenoble|