Exploring Motor Learning in Acute Stroke Through Robotics (NCT04171856) | Clinical Trial Compass
RecruitingNot Applicable
Exploring Motor Learning in Acute Stroke Through Robotics
Belgium245 participantsStarted 2020-01-01
Plain-language summary
The acute phase of stroke is characterized by an enhancement of neural plasticity which supports rapid motor recovery. It is unclear whether acute stroke patients can acquire new motor skills with their affected upper limb. The aims of this research program are:
1. To test the capacity of acute stroke patients (\< 21 days) to learn and retain a complex unimanual motor skill.
2. To explore whether acute stroke to different brain regions (quantified with brain MRI) induces specific deficits in motor skill learning.
3. To compare acute stroke patients with healthy individuals and with chronic stroke patients.
Who can participate
Age range
18 Years – 90 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.
ACUTE STROKE PATIENTS:
Inclusion Criteria:
* acute stroke (\> 21 days)
* aged 18-90 years
* with a stroke lesion on brain imaging
Exclusion Criteria:
* " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophoby, etc ...)
* difficulty in understanding or executing commands
* drug/alcohol abuse
* severe aphasia / cognitive deficits interfering with study
* inability to voluntarily move the affected arm (i.e. complete paralysis of the arm)
* multiple strokes / dementia / psychiatric condition
PATIENTS WITH TRANSIENT GLOBAL AMNESIA:
Clinical diagnosis, criteria of Hodge \& Warlow (1990):
* Anterograde amnesia observed by a witness
* No alteration of consciousness or loss of identity
* Cognitive dysfunction limited to amnesia
* Lack of focused neurological deficit or argument for a comitiality
* Absence of head trauma
* Symptom resolution within 24 hours
* Possible existence of vegetative symptoms
Inclusion criteria:
* Transient global amnesia
* 8-90 years old
* Be able to perform 3 consecutive sessions on a rehabilitation robot
Exclusion criteria:
* Severe aphasia / cognitive deficits interfering with study
* Psychiatric disorders
* Alcohol / drug addiction
* Exclusion criteria related to MRI
HEALTHY INDIVIDUALS:
Inclusion Criteria:
• 18-90 years
Exclusion Criteria:
* medical history with a previous stroke/neurological deficit
* drug/alcohol abuse
* psychiatric condition/ dementia
CHRONIC STR…
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
change in SAT (CIRCUIT)
Timeframe: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
2
total distance travelled (EASY)
Timeframe: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)