An observational study in TBI (Traumatic Brain Injury), sponsored by Clinique Romande de Readaptation. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by Clinique Romande de Readaptation · Observational
Standard neuropsychological evaluations after severe TBI (traumatic brain injury) often minimizes the executive deficits, these latter are known to seriously impair return to work. Therefore, we developed an ecological organization and problem-solving test in a vocational setting called the TEM-PRO. The test consists of 4 activities of variable complexity, collection and redaction of information and demands to follow well defined rules.
While there may be many reasons for obtaining neuropsychological assessement after TBI, predication of the real world functioning is generally the final goal. Among the cognitive deficits, the dysexecutive syndrome is certainly the most disabling in impeding to return to work. The classical neuropsychological tests often fail to asses theses deficits adequately. Several more ecological tests have been previously developed. Based on the multiple errands test and the six elements test, we built up first an ecological test over 60 minutes for activities of the daily living (test des errances multiples, " TEM, version CRR "). Used regularly in the clinical setting, it was able to evaluate the functional aptitudes of the patients and was useful to complete the classical neuropsychological tests. However test duration is too short and activities are far away from real work scenarios to test working aptitudes. Therefore we developed a new executive-ecological test in a vocational setting (TEM-PRO). The adaptation of the original test in a vocational setting induces the addition of 4 activities of variable complexity, research and redaction of information and demands to follow well defined rules. Skills that are solicited are planning, selective and sustained attention, prospective memory, organization, problems solving and behavior adaption over a long period of time. Based on a pilot study with patients without neurological deficit we assessed that our test displayed good sensitivity without ceiling effect. It allowed a quantitative and differentiated evaluation, a classification of various error types (interpretation and judgment failure, rule breaks, task failures and inefficiencies) and provided a qualitative behavioral analysis.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's enrollment of 40 is below the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Clinique Romande de Readaptation is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Patients with a moderate to severe traumatic brain injury returning to work
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
French speaking patients, older than 18 years, able to understand and sign the study , able to answer questionnaires used in the study, suffering from moderate to severe TBI, without invalidate psychiatric comorbidities, without severe memory impairment, capable to participate for 4h in a vocational activity, planning to return to work. Patients still receiving compensation and patients returned to work will be included
Exclusion Criteria:
alcohol or drug abuse, severe physical disability interfering with the test (modified Ranking score >1), under legal custody.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The following data will be collected: (1) sociodemographic variables (2); clinical and psychological data; (3) functional tests (neuropsychological testing, TEM version CRR and TEM-PRO). On day one, patients will undergo standard neuropsychological tests and questionnaires listed hereafter, which are commonly used in the clinical practice at the CRR. * The Patient Competency Rating Scale (PCRS) * TEM (Multiple errands test) * GREFEX * 5 POINTS TEST * TAP 2.3 * Behavioral Assessment of the Dysexecutives Syndrome (BADS) On day two, the patients will perform the TEM-PRO test ambulatory in our vocation rehabilitation unit. "Predictors" variables will be collected before testing: Sociodemographic: age, sex, education, marital status, mother language, time since TBI, severity of the TBI (moderate or severe), type of lesion (contusion, diffuse axonal injury grade 1-3, ischemic or other complications), history of TBI, stroke or meningitis.
Evaluation of the feasibility of the test.
Is it suitable for TBI patients?
Time frame: 2020
Evaluation of the criterion validity of the TEM-PRO
Evaluation of the reproducibility of the test
Time frame: 2020
Comparaison of the diagnostic value of the TEM-PRO with the classical Neuropsychological test and the TEM.
Comparison with existing tests
Time frame: 2020
Evaluation of the association between RTW and TEM-PRO
Can the test be a predictor of RTW?
Time frame: 2022
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Clinique Romande de Readaptation