Functional Characterisation of Post-stroke Fatigue

Study Overview
=================
Brief Summary
-----------------
Post-stroke fatigue is highly prevalent and disabling. However, its causes and consequences in the chronic phase are not fully understood. The aim of this cross-sectional study is to explore functional correlates of post-stroke fatigue in the chronic phase.

Official Title
-----------------
Functional Characterisation of Post-stroke Fatigue: a Cross-sectional Study

Conditions
-----------------
Stroke, Stroke Sequelae

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mini Mental State Evaluation > 24 Stroke > 6 months ago Exclusion Criteria: Current active infection Multiple stroke Other affection of the central nervous system Medication potentially inducing severe fatigue Hospital admission during last month Severe Apraxia Severe Aphasia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale (FSS) | 9-item fatigue scale (Score/7) Minimum value = 1, Maximum value = 7 An average score greater than or equal to four signifies pathological fatigue | assessment during 1 day study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep quality index | Sleep assessment. The score of seven components are summed to provide a global score from 0 to 21. A global score greater than five is indicative of poor sleep | assessment during 1 day study visit | 
| ACTIVLIM specific to patients with stroke | Rasch-validated activity assessment. Self-report 20-item questionnaire based on the International Classification of Functioning, Disability and Health and includes activities related to self-care, transfer, mobility, manual ability and balance. Participants have to evaluate the perceived difficulty of performing each activity if realised without technical or human assistance. Each item has three response possibilities (impossible, difficult, easy) | assessment during 1 day study visit | 
| Hospital Anxiety and Depression Scale (HADS) | Mood assessment. Self-report questionnaire with anxiety and depression subscales, each consisting of 7 questions. Score each item from 0 (no symptoms) to 3 points (maximum impairment) The cutoff for a pathological score is ≥ 7 for each subscale | assessment during 1 day study visit | 
| 6-minute walk test | Speed decrement (distance first minute - distance last minute). The distance walked each minute and the total distance walked were measured. Performance fatigability was assessed by the difference of distance walked during the first and sixth minutes. | assessment during 1 day study visit | 
| Neuromuscular Fatigability Index | Decrement in isometric strength of knee extensors during fatiguing task The NMFI is calculated by the difference between the putative torque-versus-time curve if the subject had maintained the maximal torque recorded during the first 5 seconds for 45 seconds, considered as a score of 100 arbitrary units, and the actual area under the torque-versus-time curve. A higher NMFI score indicates higher fatigability | assessment during 1 day study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fatigue, fatigability, functional impairment