NCT06870682Completed
Potential Effects of Novel Sensorimotor Upper Limb Rehabilitation Paradigm
Potential Effects of a Robot-based Upper Limb Rehabilitation Paradigm in Different Subgroups After Stroke: a Pilot Study
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal intervention combining both motor and sensory function, with focus on sensory processing (one of the most important sensory functions), does not exists. However, the research team has developed a novel therapy paradigm combining robot-based training, a transfer package to daily life activities, and a home program. As a first step, the investigators will examine the feasibility and potential benefits of this novel therapy approach within this pilot study by recruiting 10 persons with chronic stroke. The investigators hypothesize that this therapy approach is feasible and potentially effective in chronic stroke.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 6 Mar 2025
- Start date
- 18 Feb 2025
- Primary completion date
- 2 Oct 2025
- Lead sponsor
- KU Leuven
- Diseases
- Stroke
- NCT number
- NCT06870682
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 18 Feb 2025 to the primary completion date, 2 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having musculoskeletal and/or other neurological disorders impacting care or prognosis
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP
- Contraindications for robot-based therapy (e.g., uncontrolled epilepsy)
- Having any contra-indications for MRI, only relevant if participant is willing to receive the additional MRI assessments:
- Pacemaker
- Implantable Cardioverter Defibrillator (ICD)
- Cochlear implant
- Internal Insulin-pump
- Deep brain stimulation
- Any other metal device in 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)
- Use (or history of use) of drugs/alcohol
- Being pregnant
Other
- Having severe communication or cognitive deficits that interfere with the protocol
- Participation in another clinical investigation
- Having uncontrolled head movements (e.g. tremor), only relevant if participant is willing to receive the additional fNIRS assessments
Who the study is looking for
- 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 years old
- 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 score \<24 out of 25
- Impaired functionality, defined as Action Research Arm Test score \<52 out of 57
- Manageable spasticity for KINARM tasks
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KU Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
Related publications
- Feasibility of ROBUST: An Integrated Sensorimotor Upper Limb Therapy for People in the Chronic Phase After Stroke.Brain Sci · 2026 · PMID 42651154
This page is information, not medical advice. Discuss any trial with your doctor.