Clinical trial NCT02971774: Development of a Multimodal Approach to Assess Stroke Patients Daily Life Activities
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke in Patients: New Tool to Evaluate the Impact in Their Life
Keywords: stroke
botulinum toxin injection
daily life
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The aim of the study consists in enriching knowledge of health professionals, on the functional difficulties encountered by hemiplegic patients outside the hospital, in particular on hobbies, going out with friends or family, work, daily life and the personal projects. Another objective is to evaluate the diversity of the attitudes and representations of the patients about their body damage. Lastly, the study seeks to develop a new grid of evaluation of the quality of life of the patients, which determines more fields of the existence significantly impacted by the hemiparesy, from the point of view of the patients. It is a question of improving the therapeutic care of the patients and to determine if various therapeutic approaches (occupational, pharmacological, surgical) have an impact on these various fields. The study will be based on qualitative data (interviews) and quantitative (questionnaires).

Detailed description: 1. 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.
2. 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).

Eligibility criteria: 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

Primary outcomes:
measure: daily life questionnary
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincaré Hospital
Study officials:
affiliation: Raymond Poincare Hospital
name: Nicolas ROCHE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: