Robot therapy aims to restore arm movement after stroke
NCT ID NCT07547800
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new robot-based therapy designed to improve arm movement and sensation in people who had a stroke more than six months ago. The therapy focuses on helping the brain better process sensory information from the arm. The trial will include 109 participants and compare the robot therapy to standard care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 109 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria stroke participants: 1. Written informed consent must be obtained prior to any screening procedures; 2. A first-ever unilateral, supra-tentorial stroke, as defined by WHO (rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than vascular origin); 3. ≥18 and ≤85 years old; 4. Being a Dutch speaker; 5. Being in the chronic phase after stroke, i.e. \> 6 months post stroke; 6. Motor impairment in the upper limb, defined as Fugl-Meyer score \>22 out of 66 to demonstrate moderate to full upper limb motor function (patients scoring \<23 out of 66 will not be able to comply with the Kinarm protocol); 7. Residual sensory upper limb impairment, defined as Tactile Discrimination Test (Area Under Curve) \<73.10%; 8. Impaired functionality, defined as sensorimotor Action Research Arm Test score \<52 out of 57; 9. Manageable spasticity for Kinarm tasks. Inclusion Criteria healthy participants: 1. Written informed consent must be obtained prior to any screening procedures; 2. ≥18 and ≤85 years old; 3. Being a Dutch or English speaker; 4. No history of stroke or transient ischemic attack; 5. No recent brain/head injury; 6. No major upper limb sensory or motor impairments. Exclusion Criteria: 1. Having musculoskeletal and/or other neurological disorders impacting care or prognosis; 2. Having severe communication or cognitive deficits that interfere with the protocol; 3. Having severe spasticity (cannot handle Kinarm robot); 4. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP; 5. Contraindications for robot-based therapy (e.g., uncontrolled epilepsy); 6. Participation in another clinical investigation; 7. Having any contraindications for fNIRS\*: * Uncontrolled head movements (e.g. tremor) * Scalp lesion at optode sites (wound/incision/infection/hematoma) * Decompressive craniectomy or large skull defect over target regions * Persistent hair-optode coupling failure despite best practices, or non-removable obstructions preventing adequate coupling 8. Having any contraindications for MRI\*\*: * Pacemaker * Implantable Cardioverter Defibrillator (ICD) * Cochlear implant * Internal Insulin-pump * Deep brain stimulation * Any other metal device in the body * Claustrophobia * Having a history of a neuropsychiatric or neurologic disorder before the diagnosis of stroke (e.g., depression, traumatic brain injury) * Use of psychoactive medication before the diagnosis of stroke (e.g., anti-depressive medication) * Misuse (or history of misuse) of drugs/alcohol 9. Currently undergoing a structured arm and/or hand training (e.g. engaging in playing a musical instrument)\*\*. * Stroke patients and healthy participants showing these exclusion criteria will be included in the RCT protocol, but will not be measured with fNIRS. * Stroke patients showing these exclusion criteria will be included in the RCT protocol, but will not be measured with MRI. Healthy adults showing these exclusion criteria will not be included in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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KU Leuven, Gebouw De Nayer
Leuven, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Moving patterns may help stroke survivors read faster
- Vibrating wearables put stroke walking to the test
- Robot plus electrical stimulation aims to rebuild arm movement after stroke
- Two estradiol dosing schedules put brain effects to the test
- Can a checklist and heart monitor stop repeat strokes?