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Status unknownNCT04277234PSF-SAGUpdated Feb 21, 2020

Functional Characterisation of Post-stroke Fatigue

An observational study in Stroke and Stroke Sequelae, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-21.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Stroke
  • Stroke Sequelae

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Keywords

  • fatigue
  • fatigability
  • functional impairment
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 100 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adults

Inclusion criteria

  • Mini Mental State Evaluation > 24
  • Stroke > 6 months ago

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: assessment during 1 day study visit

Secondary outcomes

  1. 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

    Time frame: assessment during 1 day study visit

  2. 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)

    Time frame: assessment during 1 day study visit

  3. 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

    Time frame: assessment during 1 day study visit

  4. 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.

    Time frame: assessment during 1 day study visit

  5. 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

    Time frame: assessment during 1 day study visit

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Study locations

1 of 1 sites recruiting
  • Cliniques universitaires Saint-Luc
    Bruxelles, 1200, Belgium
    Recruiting
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References and documents

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. PubMed 32740873 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04277234
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Centre Hospitalier Universitaire UCLouvain Namur, CHU Ambroise-Paré - Mons
Responsible party
Sponsor
First posted
Feb 20, 2020
Start date
Oct 25, 2018
Primary completion
Mar 2020 (estimated)
Completion
May 2020 (estimated)
Last update
Feb 21, 2020

Study contacts

Thierry Lejeune, MD
Contact
thierry.lejeune@uclouvain.be
+3227641648

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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