Functional Characterisation of Post-stroke Fatigue

Stroke Clinical Trial

— PSF-SAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04277234
• Other study ID #: PSF-SAG
• Secondary ID: 2017/14SEP/443
• Status: Recruiting
• Start date: October 25, 2018
• Est. completion date: May 2020

Study information

• Verified date: February 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Thierry Lejeune, MD
• Phone: +3227641648
• Email: thierry.lejeune[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Stroke
• Stroke Sequelae

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Bruxelles

Sponsors (3)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Centre Hospitalier Universitaire Dinant Godinne - UCL Namur, CHU Ambroise-Paré - Mons

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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