Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke (NCT07547800) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke
Belgium109 participantsStarted 2026-04-17
Plain-language summary
Sensorimotor function of the upper limb is commonly impaired after stroke, even in the chronic phase (\>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. It is important that those three components will each be addressed in the upper limb rehabilitation. Unfortunately, there is still no optimal therapy to address sensory processing. Therefore, the investigators developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, the investigators did a pilot study (S69003) including 10 persons with chronic stroke to investigate the potential effectiveness and feasibility of this novel rehabilitation. The median change score of motor, sensory and sensorimotor assessments was exceeding the minimal clinical important difference (MCID), and the total amount of therapy was feasible as well. The investigated protocols to measure potential changes in brain function (activity and connectivity) and structure accompanying the novel therapy appeared feasible as well. Based on this first pilot study, the investigators finalized the protocol for this RCT to investigate the effectiveness of the ROBUST intervention.
Who can participate
Age range
18 Years – 85 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
. Written informed consent must be obtained prior to any screening procedures;
. 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);
. ≥18 and ≤85 years old;
. Being a Dutch speaker;
. Being in the chronic phase after stroke, i.e. \> 6 months post stroke;
. 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);
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
Action Research Arm Test
Timeframe: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).