Pressure Ulcer Formation Prevention in Paraplegics Using... | NCT00429013

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

NCT00429013

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Sep 15, 2016Estimated

Enrollment

12Actual

Phase

Phase 2

Conditions

PARAPLEGIA

Interventions

Tongue Display Unit

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

principal criteria was achieved with the intermediate statistical analysis

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jan 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jan 29, 2007

First Submission Date that Met QC Criteria

Jan 29, 2007

First Posted Date

Jan 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2016

Last Update Posted Date

Sep 15, 2016Estimated

Name	Class
Centre Medico Universitaire Daniel Douady (CMUDD)	OTHER
TIMC-IMAG	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	No Intervention	no medical device
1	Experimental	medical device	Device: Tongue Display Unit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tongue Display Unit	Device	lingual electric stimulation	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre Moreau-Gaudry, Ph.D. M.D.	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Grenoble		Grenoble	Cedex 09	38043	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17108630	Background	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.

ID	Term
D010243	Paralysis
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

ID	Term
D010264	Paraplegia
D003668	Pressure Ulcer