- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02971774
Development of a Multimodal Approach to Assess Stroke Patients Daily Life Activities
Development of a Multimodal Approach to Assess Stroke Persons Daily Life Activities and Development of a New Tool to Evaluate the Impact of Functional Activites on Quality of Life
Studie Overzicht
Toestand
Gedetailleerde beschrijving
- To conduct the research, a sociologist will collaborate with Doctor Nicolas Roche, the study director. The contribution of a sociologist will offer a viewpoint from outside the medical aspect, which will allow more global identification of the areas of the lives of patients that are affected by hemiparesis. Furthermore, the sociological perspective will seek to demonstrate the social aspects, which have heretofore been explored little or not at all in medical and public health studies, such as, for example, in terms of intimacy or self-image. It must delicately capture the practices, logic of action and though of the patients, by placing them in the social contexts in which they evolve and develop. Therefore, attention will be paid to certain "social determinants" (such as sociocultural setting, age or gender) and certain resources (particularly economic, relational and material), which can have an effect on the ways in which patients perceive and cope with the consequences of their hemiparesis. The role of loved ones (partner, family members, friends) will also be examined, since many sociological works have shown that they are usually on the front line to accompany, shape and manage the effects of the motor impairment.
- The study will target adults regularly followed in the department of physical medicine and rehabilitation of the Raymond-Poincaré hospital. These individuals must present with hemiparesis secondary to a single, hemispheric cerebrovascular accident, be living at home and be able to move inside and outside of the home.
Patients having several severe cognitive disorders or aphasia will not be interviewed.
The study will include an exploration phase (a corpus of approximatively 30 examinations) and a quantitative component (approximatively 100 questionnaires).
Once the examinations have been completed, the preparation of the questionnaire will be done with the validation of clinical experts. The questionnaire will include approximately 20 items, distributed over several dimensions of patients' lives. The participants' response time to the questionnaire should be in a range from 8 to 12 minutes, in order to facilitate its insertion in the professional practices when the patients are at a hospital visit.
The researcher will be in charge of completion of the questionnaire. This will be performed around or during the consultation of patients at Raymond-Poincaré hospital. The first completions will be recorded (with the written approval of surveyed patients) in order to be able to work on possible improvements, particularly in terms of the order of questions or in their understanding and response options. After ten completions, the questionnaire will be slightly revised if modifications appear necessary, then will remain the same until the desired volume of questionnaires is received (approximatively 100).
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Garches, Frankrijk, 92380
- Werving
- Raymond Poincaré Hospital
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Contact:
- Nicolas Roche, MD PhD
- Telefoonnummer: 0033147105409
- E-mail: roche.nicolas@aphp.fr
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patient older than 18 years old
- patient with hemiparesis secondary to a single hemispheric cerebrovascular accident
- be living at home
- be able to move inside and outside of the home
Exclusion Criteria:
- Patients having several severe cognitive disorders
- Patients having severe aphasia
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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questionnary
self administered questionnary
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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daily life questionnary
Tijdsspanne: 45 minutes
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45 minutes
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2005997
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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