Functional Characterisation of Post-stroke Fatigue (PSF-SAG)

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Stroke Sequelae

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Maxime Valet, MD; Phone Number: +32 2 764 53 75; Email: maxime.valet@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adults

Description

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 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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborators: Centre Hospitalier Universitaire Dinant Godinne - UCL Namur; CHU Ambroise-Paré - Mons

Publications and helpful links

General Publications

• Rahamatali M, De Bont N, Valet M, Halkin V, Hanson P, Deltombe T, Lejeune T, Selves C. Post-stroke fatigue: how it relates to motor fatigability and other modifiable factors in people with chronic stroke. Acta Neurol Belg. 2021 Feb;121(1):181-189. doi: 10.1007/s13760-020-01453-9. Epub 2020 Aug 1.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: fatigue; fatigability; functional impairment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Fatigue
• Other Study ID Numbers: PSF-SAG; 2017/14SEP/443 (Other Identifier: CEHF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No