StrokePSF-SAGNCT04277234
Functional Characterisation of Post-stroke Fatigue
An observational study of Stroke and Stroke Sequelae, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Stroke Sequelae
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Oct 2018to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults
Who may be able to join
- Mini Mental State Evaluation > 24
- Stroke > 6 months ago
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Maxime Valet, MD, +32 2 764 53 75, maxime.valet@uclouvain.be
About this study
Official title: 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.
- Conditions
- Stroke, Stroke Sequelae
- Keywords
- fatigue, fatigability, functional impairment
- Medical subject headings
- Stroke, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: assessment during 1 day study visit
Secondary outcomes (5)
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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: assessment during 1 day study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start25 Oct 2018
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur, CHU Ambroise-Paré - Mons
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277234
- Sponsor's protocol ID
- PSF-SAG
- Other IDs
- 2017/14SEP/443
- Acronym
- PSF-SAG
- Status last verified
- Feb 2020
- First submitted
- 21 Feb 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Characterisation of Post-stroke Fatigue: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04277234
- Acronym / sponsor ID
- PSF-SAG / PSF-SAG
- Conditions
- Stroke, Stroke Sequelae
- Keywords
- fatigue, fatigability, functional impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur, CHU Ambroise-Paré - Mons
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults
Key inclusion criteria (2 listed)
- Mini Mental State Evaluation > 24
- Stroke > 6 months ago
Key exclusion criteria (7 listed)
- Current active infection
- Multiple stroke
- Other affection of the central nervous system
- Medication potentially inducing severe fatigue
- Hospital admission during last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue Severity Scale (FSS)
Time frame: 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
5 secondary outcomes
Pittsburgh Sleep quality index
Time frame: assessment during 1 day study visit
ACTIVLIM specific to patients with stroke
Time frame: assessment during 1 day study visit
Hospital Anxiety and Depression Scale (HADS)
Time frame: assessment during 1 day study visit
6-minute walk test
Time frame: assessment during 1 day study visit
Neuromuscular Fatigability Index
Time frame: assessment during 1 day study visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 32740873Rahamatali 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.
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Stroke Sequelae, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thierry Lejeune, MD (+3227641648, thierry.lejeune@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (FSS) (time frame: assessment during 1 day study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04277234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.