Functional Characterisation of Post-stroke Fatigue

• Conditions: Stroke Sequelae; Stroke

• Registration Number: NCT04277234
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-25
• Study First Submitted: 2019-02-21
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-19
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-21
• Primary Completion: 2020-03
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep quality index	assessment during 1 day study visit	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
ACTIVLIM specific to patients with stroke	assessment during 1 day study visit	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)
Hospital Anxiety and Depression Scale (HADS)	assessment during 1 day study visit	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
6-minute walk test	assessment during 1 day study visit	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.
Neuromuscular Fatigability Index	assessment during 1 day study visit	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

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium