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

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 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
• 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
• 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.

Other

• Having severe communication or cognitive deficits that interfere with the protocol;
• Having severe spasticity (cannot handle Kinarm robot);
• Participation in another clinical investigation;

• 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;
• Manageable spasticity for Kinarm tasks.
• Written informed consent must be obtained prior to any screening procedures;
• ≥18 and ≤85 years old;
• Being a Dutch or English speaker;
• No history of stroke or transient ischemic attack;
• No recent brain/head injury;
• No major upper limb sensory or motor impairments.