Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke: a Ran… (NCT07547800) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke: a Randomized Controlled Trial
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, we developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, we 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, we finalized the protocol for this RCT to investigate the effectiveness of the ROBUST intervention.
Who can participate
Age range18 Years – 85 Years
SexALL
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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);
✓. Residual sensory upper limb impairment, defined as Tactile Discrimination Test (Area Under Curve) \<73.10%;
✓. Impaired functionality, defined as sensorimotor Action Research Arm Test score \<52 out of 57;
Exclusion criteria
What they're measuring
1
Action Research Arm Test
Timeframe: From first measuring moment to last measuring moment after 9-18 weeks (depending on group allocation).