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Clinical Trials/NCT02971774
NCT02971774
Unknown
Not Applicable

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

Centre d'Investigation Clinique et Technologique 8051 site in 1 country100 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke in Patients: New Tool to Evaluate the Impact in Their Life
Sponsor
Centre d'Investigation Clinique et Technologique 805
Enrollment
100
Locations
1
Primary Endpoint
daily life questionnary
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
December 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

daily life questionnary

Time Frame: 45 minutes

Study Sites (1)

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