NCT00429013

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

January 29, 2007

Last Update Submit

September 14, 2016

Conditions

PARAPLEGIA

Keywords

Pressure ulcerLingual electric stimulationParaplegic patientPressure Ulcer/Prevention & control

Outcome Measures

Primary Outcomes (1)

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

    3 weeks

Secondary Outcomes (3)

  • Qualitative and quantitative knowledge evaluation

    3 weeks

  • Qualitative medical device evaluation

    3 weeks

  • Adverse event collection

    3 weeks

Study Arms (2)

2

NO INTERVENTION

no medical device

1

EXPERIMENTAL

medical device

Device: Tongue Display Unit

Interventions

Tongue Display UnitDEVICE

lingual electric stimulation

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient affiliated to social security or similarly regime
  • paraplegic medullary patient
  • more or equal than 18 years old.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, Cedex 09, 38043, France

Location

Related 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.

    PMID: 17108630BACKGROUND

MeSH Terms

Conditions

ParaplegiaPressure Ulcer

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

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

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 30, 2007

Study Start

September 1, 2006

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

FR(1)