Validation of an Ecological Organization and Problem Solving Test (TEM-PRO) in Vocational Rehabilitation

Sponsor
Clinique Romande de Readaptation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04087486
Collaborator
(none)
40
1
44.9
0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Implementation of a behavioural test for patients with TBI

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation of an Ecological Organization and Problem Solving Test (TEM-PRO)
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the feasibility of the test. [2020]

    Is it suitable for TBI patients?

Secondary Outcome Measures

  1. Evaluation of the criterion validity of the TEM-PRO [2020]

    Evaluation of the reproducibility of the test

  2. Comparaison of the diagnostic value of the TEM-PRO with the classical Neuropsychological test and the TEM. [2020]

    Comparison with existing tests

  3. Evaluation of the association between RTW and TEM-PRO [2022]

    Can the test be a predictor of RTW?

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

French speaking patients, older than 18 years, able to understand and sign the study informed consent, 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique romande de réadaptation Sion Valais Switzerland 1951

Sponsors and Collaborators

  • Clinique Romande de Readaptation

Investigators

  • Principal Investigator: Andreas Mühl, MD, Clinique romande de réadaptation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinique Romande de Readaptation
ClinicalTrials.gov Identifier:
NCT04087486
Other Study ID Numbers:
  • CliniqueRR-07
First Posted:
Sep 12, 2019
Last Update Posted:
Aug 10, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Clinique Romande de Readaptation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2021