Clinical Trial: Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.
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 Summary:
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.
Sponsor: University Hospital, Grenoble
Current Primary Outcome: Difference of adapted movement (in term of pressure) between the A and B groups. [ Time Frame: 3 weeks ]
Original Primary Outcome: Difference of adapted movement (in term of pressure) between the A and B groups.
Current Secondary Outcome:
- Qualitative and quantitative knowledge evaluation [ Time Frame: 3 weeks ]
- Qualitative medical device evaluation [ Time Frame: 3 weeks ]
- Adverse event collection [ Time Frame: 3 weeks ]
Original Secondary Outcome:
- Qualitative and quantitative knowledge evaluation
- Qualitative medical device evaluation
- Adverse event collection
Information By: University Hospital, Grenoble
Dates:
Date Received: January 29, 2007
Date Started: September 2006
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016
