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

Primary Purpose

PARAPLEGIA

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Tongue Display Unit

About this trial

This is an interventional prevention trial for PARAPLEGIA focused on measuring Pressure ulcer, Lingual electric stimulation, Paraplegic patient, Pressure Ulcer/Prevention & control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

no medical device

medical device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Qualitative and quantitative knowledge evaluation

Qualitative medical device evaluation

Adverse event collection

Full Information

NCT ID

NCT00429013

First Posted

January 29, 2007

Last Updated

September 14, 2016

Sponsor

University Hospital, Grenoble

Collaborators

Centre Medico Universitaire Daniel Douady (CMUDD), TIMC-IMAG

1. Study Identification

Unique Protocol Identification Number

NCT00429013

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

principal criteria was achieved with the intermediate statistical analysis

Study Start Date

September 2006 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Grenoble

Collaborators

Centre Medico Universitaire Daniel Douady (CMUDD), TIMC-IMAG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PARAPLEGIA

Keywords

Pressure ulcer, Lingual electric stimulation, Paraplegic patient, Pressure Ulcer/Prevention & control

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

no medical device

Arm Title

Arm Type

Experimental

Arm Description

medical device

Intervention Type

Device

Intervention Name(s)

Tongue Display Unit

Intervention Description

lingual electric stimulation

Primary Outcome Measure Information:

Title

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

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Qualitative and quantitative knowledge evaluation

Time Frame

3 weeks

Title

Qualitative medical device evaluation

Time Frame

3 weeks

Title

Adverse event collection

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

University Hospital, Grenoble

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Grenoble

City

Grenoble

State/Province

Cedex 09

ZIP/Postal Code

38043

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

17108630

Citation

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.

Results Reference

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

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