Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without… (NCT03259932) | Clinical Trial Compass
WithdrawnNot Applicable
Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without Physical Training
Stopped: The study could not be set up due to recruitment and feasibility problems
0Started 2017-10
Plain-language summary
After a minor stroke, patients frequently report complaints such as fatigue and difficulty with certain everyday motor tasks, leading to a marked deterioration in their quality of life. The aim of this study is to show that the implementation of a personalised physical activity programme, starting 1 month after the hospitalisation for minor stroke, significantly decreases the frequency of fatigue in these patients, in comparison with usual management "in real life"..
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years
* National health insurance cover
* 1st minor ischaemic stroke (initial NIH score ≤ 4)
* Satisfactory neurological recovery at discharge from hospital (modified Rankin score ≤2)
* Patient living close to the participating centre (\<50 km)
* With early post-stroke fatigue (FFS score ≥ 4 at the definitive inclusion visit (W3))
Exclusion Criteria:
* haemorrhagic stroke
* History of ischaemic or haemorrhagic stroke with clinical manifestations
* History of TIA
* MMS ≤ 24
* Pre-existing dementia (defined according to DSM IV criteria)
* Neurosensory or orthopaedic disorders requiring permanent technical support before the stroke and making reconditioning impossible
* Aggravation of the neurological status after the initial hospitalisation (NIH score ≥ 6)
* Recurrence of the cerebrovascular event or onset of an acute cardio-vascular event between the screening and definitive inclusion
* Pre-stroke Rankin score ≥ 3
* Pregnant patient
* Patient under guardianship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue relief (assessed by the Fatigue Severity Scale)