Evaluate the Frequency of Fatigue After Cerebral Infarction

Symptomatic Cerebral Infarction Clinical Trial

— Fatigue AVC  

Official title:

Fatigue After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288090
• Other study ID #: Béjot 2017
• Status: Completed
• Start date: September 11, 2017
• Est. completion date: November 22, 2018

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 22, 2018
• Est. primary completion date: November 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction
• Symptomatic Cerebral Infarction

Intervention

Other:
• 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).
• Neuropsychological evaluation battery
A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.
• 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

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue evaluated using the Fatigue Severity Scale (FSS)		6 months