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

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Brief Title

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

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 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Difference of adapted movement (in term of pressure) between the A and B groups.

Secondary Outcome

 Qualitative and quantitative knowledge evaluation

Condition

PARAPLEGIA

Intervention

Tongue Display Unit

Study Arms / Comparison Groups

 2
Description:  no medical device

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

12

Start Date

September 2006

Completion Date

March 2009

Primary Completion Date

January 2009

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alexandre Moreau-Gaudry, Ph.D. M.D., , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00429013

Organization ID

DCIC-05-44


Responsible Party

Sponsor

Study Sponsor

University Hospital, Grenoble

Collaborators

 Centre Medico Universitaire Daniel Douady (CMUDD)

Study Sponsor

Alexandre Moreau-Gaudry, Ph.D. M.D., Principal Investigator, University Hospital, Grenoble


Verification Date

September 2016