Evaluate the Frequency of Fatigue After Cerebral Infarction

NCT ID: NCT03288090

Last Updated: 2022-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-11

Study Completion Date

2018-11-22

Brief Summary

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Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among these sequelae, fatigue is frequently reported by patients. It is therefore important for doctors to understand why patients suffer from fatigue after cerebral infarction and to determine whether treatments given for the cerebral infarction may have an impact on this fatigue.

The aim of this research was to study the frequency of fatigue after cerebral infarction, the associated factors, in particular the impact of treatments administered in the acute phase.

Detailed Description

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Conditions

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Symptomatic Cerebral Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treated

FSS: Fatigue Severity Scale

Intervention Type OTHER

Fatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category).

Neuropsychological evaluation battery

Intervention Type OTHER

A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.

Other functional scores

Intervention Type OTHER

Rankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale

Non-treated

FSS: Fatigue Severity Scale

Intervention Type OTHER

Fatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category).

Neuropsychological evaluation battery

Intervention Type OTHER

A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.

Other functional scores

Intervention Type OTHER

Rankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale

Interventions

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FSS: Fatigue Severity Scale

Fatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category).

Intervention Type OTHER

Neuropsychological evaluation battery

A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.

Intervention Type OTHER

Other functional scores

Rankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients presenting recent symptomatic cerebral infarction (\< 1 week) defined according to World Health Organization (WHO) criteria and hospitalised at the Stroke Unit in Dijon University.
* Patients aged 18 years or older.
* Patients who have been informed about the study, or their person of trust for patients unable to express their consent.

Exclusion Criteria

* Patients (or their person of trust) who refuse to participate in the study.
* Subjects in custody.
* Patients presenting prior co-morbidity as a cause of significant fatigue in the opinion of the investigator
* Patients with dementia or aphasia before the stroke
* Patients (or their person of trust) who may be difficult to contact by telephone during the follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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Béjot 2017

Identifier Type: -

Identifier Source: org_study_id

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