Clinical Trial

Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke

Study acronym: RCT ROBUST
Not Yet Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-17.
Trial Details
NCT Number NCT07547800
Lead Sponsor KU Leuven
Conditions Stroke, Healthy Adult
Enrollment 109 participants
Start Date 2026-04-17
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-11