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
  Purpose

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.


Condition Intervention Phase
Paraplegia
Device: Tongue Display Unit
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Difference of adapted movement (in term of pressure) between the A and B groups. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: September 2006
Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
no medical device
Experimental: 1
medical device
Device: Tongue Display Unit
lingual electric stimulation

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429013

Locations
France
University Hospital of Grenoble
Grenoble, Cedex 09, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Centre Medico Universitaire Daniel Douady (CMUDD)
TIMC-IMAG
Investigators
Principal Investigator: Alexandre Moreau-Gaudry, Ph.D. M.D. University Hospital, Grenoble
  More Information

Additional Information:
Publications:
Responsible Party: Dr Alexandre Moreau-Gaudry, University Hospital of Grenoble
ClinicalTrials.gov Identifier: NCT00429013     History of Changes
Other Study ID Numbers: DCIC-05-44
Study First Received: January 29, 2007
Last Updated: May 25, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Pressure ulcer
Lingual electric stimulation
Paraplegic patient
Pressure Ulcer/Prevention & control

Additional relevant MeSH terms:
Pressure Ulcer
Paraplegia
Skin Ulcer
Skin Diseases
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014