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

PARAPLEGIA Clinical Trial

Official title:

A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00429013
• Other study ID #: DCIC-05-44
• Status: Terminated
• Phase: Phase 2
• First received: January 29, 2007
• Last updated: September 14, 2016
• Start date: September 2006
• Est. completion date: March 2009

Study information

• Verified date: September 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• PARAPLEGIA
• Pressure Ulcer

Intervention

Device:
• Tongue Display Unit
lingual electric stimulation

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble	Cedex 09

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Centre Medico Universitaire Daniel Douady (CMUDD), TIMC-IMAG

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of adapted movement (in term of pressure) between the A and B groups.		3 weeks	No
Secondary	Qualitative and quantitative knowledge evaluation		3 weeks	No
Secondary	Qualitative medical device evaluation		3 weeks	Yes
Secondary	Adverse event collection		3 weeks	Yes

External Links

•   First works on sensory substitution