Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via th… (NCT00429013) | Clinical Trial Compass
TerminatedPhase 2
Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
Stopped: principal criteria was achieved with the intermediate statistical analysis
France12 participantsStarted 2006-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference of adapted movement (in term of pressure) between the A and B groups.