Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429013
Status:
TERMINATED
Last Update Posted:
2016-09-15
First Post:
2007-01-29
Brief Title:
Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
A Prospective Randomised Controlled Open Study Phase II Treatment Equivalent
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
principal criteria was achieved with the intermediate statistical analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 seatskin 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 seatskin 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
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 seatskin 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None