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

NCT ID: NCT00429013

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-03-31

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.

Conditions

PARAPLEGIA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

2

no medical device

Group Type: NO_INTERVENTION

No interventions assigned to this group

1

medical device

Group Type: EXPERIMENTAL

Tongue Display Unit

Intervention Type: DEVICE

lingual electric stimulation

Interventions

Tongue Display Unit

lingual electric stimulation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Medico Universitaire Daniel Douady (CMUDD)

OTHER

Sponsor Role: collaborator

TIMC-IMAG

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital of Grenoble

Grenoble, Cedex 09, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 17108630 (View on PubMed)

Other Identifiers

DCIC-05-44

Identifier Type: -

Identifier Source: org_study_id