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Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.

This study has been terminated.
(principal criteria was achieved with the intermediate statistical analysis)
Sponsor:
Collaborators:
Centre Medico Universitaire Daniel Douady (CMUDD)
TIMC-IMAG
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00429013
First received: January 29, 2007
Last updated: May 25, 2009
Last verified: May 2009

January 29, 2007
May 25, 2009
September 2006
January 2009   (final data collection date for primary outcome measure)
Difference of adapted movement (in term of pressure) between the A and B groups. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Difference of adapted movement (in term of pressure) between the A and B groups.
Complete list of historical versions of study NCT00429013 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Qualitative and quantitative knowledge evaluation
  • Qualitative medical device evaluation
  • Adverse event collection
Not Provided
Not Provided
 
Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Paraplegia
Device: Tongue Display Unit
lingual electric stimulation
  • No Intervention: 2
    no medical device
  • Experimental: 1
    medical device
    Intervention: Device: Tongue Display Unit
Moreau-Gaudry A, Prince A, Demongeot J, Payan Y. A new health strategy to prevent pressure ulcer formation in paraplegics using computer and sensory substitution via the tongue. Stud Health Technol Inform. 2006;124:926-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
March 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patient affiliated to social security or similarly regime
  • paraplegic medullary patient
  • more or equal than 18 years old.

Exclusion Criteria:

patients will be excluded if at least one of the following criteria is present :

  • pregnancy and feeding women
  • persons without liberty by administrative or judiciary decision
  • persons hospitalized without consent
  • persons concerned by a justice protection action
  • dependant major person
  • palatine prosthesis intolerance
  • buttock pressure ulcer evolution
  • acute pathology (particularly mouth level)
  • nickel allergy
  • impossibility to use the medical device, to understand or realize the protocol due to cognitive pathologies.
  • patient with dental troubles incompatible with the realisation or utilisation of orthodontic prothesis.
  • no tactile feeling with tongue,
  • impossibility to set up the orthodontic prothesis due to superior limb deterioration
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00429013
DCIC-05-44
Yes
Dr Alexandre Moreau-Gaudry, University Hospital of Grenoble
University Hospital, Grenoble
  • Centre Medico Universitaire Daniel Douady (CMUDD)
  • TIMC-IMAG
Principal Investigator: Alexandre Moreau-Gaudry, Ph.D. M.D. University Hospital, Grenoble
University Hospital, Grenoble
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP