the efficacy of upper limb rehabilitation with exoskeleton in patients with subacute stroke.

Conditions: Stroke; Upper Extremity Paresis

Summary: loss of arm function is a common and distressing consequence of stroke. neurotechnology-aided rehabilitation could be a promising approach to accelerate the recovery of upper limb functional impairments. this multicentre randomized controlled trial is aimed at assessing the efficacy of robot-assisted upper limb rehabilitation in subjects with sub-acute stroke following a stroke, compared to the traditional upper limb rehabilitation.

stroke is the most common cause of complex adult disability in high-income countries \[1\]. loss of arm function affects 69% of people who have a stroke \[2\]. only 12% of people with arm weakness at the onset of stroke make a full recovery \[3\]. improving arm function has been identified as a research priority by stroke survivors, carers, and health professionals who report that current rehabilitation pays insufficient attention to arm recovery \[4\]. robot-assisted training enables a greater number of repetitive tasks to be practiced in a consistent and controllable manner. repetitive task training is known to drive hebbian plasticity, where the wiring of pathways that are coincidently active is strengthened \[5, 6\]. a dose of greater than 20 h of repetitive task training improves upper limb motor recovery following a stroke \[7\] and, therefore, robot-assisted training has the potential to improve arm motor recovery after stroke. we anticipate that hebbian neuroplasticity, which is learning dependent, will operate regardless of the post-stroke phase. we, hereby, describe the protocol for a multicentre randomized controlled trial to determine whether robot-assisted training improves upper limb function following a stroke in the sub-acute stage.

Eligibility criteria:
inclusion criteria: * age between 18 and 85 years; * first stroke with neurological outcomes affecting the upper limb; * patients with severe or moderate hemiparesis (fm-ul≤44), stratified according to severe (fm-ul ≤ 22) or moderate (22 \<fm-ul ≤ 44) motor deficit; * patients in the sub-acute phase within 90 days of the acute event, stratified by the distance from the acute event (oai≤30; oai\> 30); * modified ashworth scale (mas) of the main components (shoulder, elbow, and wrist) of the upper limb \<3; * sufficient cognitive and linguistic level to understand the instructions and provide consent; * signed informed consent. exclusion criteria: * unstable general clinical conditions; * severe visual impairment; * inability to maintain the sitting position; * mild motor deficit of the arm (fm-ul\> 44) at baseline; * recent botox injection in the upper limb or planned botox injection during the study period, including the follow-up; * inability to don the orthosis on the impaired upper limb; * bone instability in relevant areas of the upper extremity (unconsolidated fractures, fractures due to osteoporosis); * fixed contractures involving the impaired upper limb (e.g. frozen shoulder); * shoulder instability; * severe pain syndromes caused or intensified by rehabilitation with armeo power; * patients who need isolation for infectious diseases ; * epileptic disorder with frequent attacks that carry the risk of having a seizure during rehabilitation with armeo power; * history of physical or neurological conditions that interfere with study procedures or assessment of motor function; * interruption of treatment for 1 week, or 5 consecutive sessions; * participation in other innovative treatment protocols for the upper limb rehabilitation (e.g. robotics, virtual reality, aot ... etc).

Keywords: stroke subacute upper limb motor function robot-assisted rehabilitation armeo power exoskeleton fugle-meyer assessment