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

September 14, 2016 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Cedex 09
      • Grenoble, Cedex 09, France, 38043
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
no medical device
Experimental: 1
medical device
Device: Tongue Display Unit
lingual electric stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference of adapted movement (in term of pressure) between the A and B groups.
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Qualitative and quantitative knowledge evaluation
Time Frame: 3 weeks
3 weeks
Qualitative medical device evaluation
Time Frame: 3 weeks
3 weeks
Adverse event collection
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

TIMC-IMAG
Centre Medico Universitaire Daniel Douady (CMUDD)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 29, 2007

First Submitted That Met QC Criteria

January 29, 2007

First Posted (Estimate)

January 30, 2007

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC-05-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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