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Functional Characterisation of Post-stroke Fatigue

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04277234
Acronym
PSF-SAG
Enrollment
100
Registered
2020-02-20
Start date
2018-10-25
Completion date
2020-05-31
Last updated
2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Stroke Sequelae

Keywords

fatigue, fatigability, functional impairment

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire UCLouvain Namur
CollaboratorOTHER
CHU Ambroise-Paré - Mons
CollaboratorUNKNOWN
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fatigue Severity Scale (FSS)assessment during 1 day study visit9-item fatigue scale (Score/7) Minimum value = 1, Maximum value = 7 An average score greater than or equal to four signifies pathological fatigue

Secondary

MeasureTime frameDescription
6-minute walk testassessment during 1 day study visitSpeed 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.
Pittsburgh Sleep quality indexassessment during 1 day study visitSleep 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 strokeassessment during 1 day study visitRasch-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 visitMood 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
Neuromuscular Fatigability Indexassessment during 1 day study visitDecrement 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

Countries

Belgium

Contacts

Primary ContactThierry Lejeune, MD
thierry.lejeune@uclouvain.be+3227641648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026