The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

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.

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).