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PSF-SAG: Functional Characterisation of Post-stroke Fatigue

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Unknown status
CT.gov ID
NCT04277234
Collaborator
Centre Hospitalier Universitaire Dinant Godinne - UCL Namur (Other), CHU Ambroise-Paré - Mons (Other)
100
Enrollment
1
Location
18.2
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Functional Characterisation of Post-stroke Fatigue: a Cross-sectional Study
    Actual Study Start Date :
    Oct 25, 2018
    Anticipated Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    May 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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)

    3. 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

    4. 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.

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cliniques universitaires Saint-Luc Bruxelles Belgium 1200

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    ClinicalTrials.gov Identifier:
    NCT04277234
    Other Study ID Numbers:
    • PSF-SAG
    • 2017/14SEP/443
    First Posted:
    Feb 20, 2020
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    fatigue
    fatigability
    functional impairment
    Additional relevant MeSH terms:
    Stroke
    Fatigue

    Study Results

    No Results Posted as of Feb 21, 2020