Effects of Using Advanced NEUROrehabilitation TECHnologies in Upper Limb Motor Function and Capacity Recovery in People With Stroke

Stroke is the second leading cause of death and the third leading cause of disability worldwide. The prevalence of upper limb motor deficits ranges approximately from 50-80% in the acute phase and from 40-50% in the chronic phase, six months after the event.

The most common upper limb impairments following stroke include paresis, altered muscle tone, reduced sensation, and loss of coordination. These deficits compromise the ability to perform activities of daily living, such as opening a door, grasping a key, or using a computer. Consequently, the recovery of upper limb motor function and capacity represents one of the primary goals of post-stroke rehabilitation.

The literature further highlights that treatment intensity, defined as a high number of repetitions, and task-oriented approaches are among the main determinants of rehabilitation effectiveness after stroke. In this context, rehabilitation technologies enable automation and intensification of treatment paradigms, improve access to therapy, and provide physiotherapists with innovative tools.

The application of these technologies in neurorehabilitation, particularly for upper limb motor recovery in adults with stroke, has led to numerous clinical studies investigating their effectiveness. Robotic rehabilitation has generally been associated with improvements in upper limb motor function. Overall, evidence indicates that technology-based interventions, such as robot-assisted therapy, virtual reality, and telerehabilitation, can enhance motor recovery when used alongside conventional treatment, particularly in individuals with moderate to severe impairments. More recent summaries of the literature further support the added value of robot-assisted approaches compared with conventional therapy alone.

Despite the growing body of evidence, several challenges remain, including population heterogeneity, variability in devices, non-standardized treatment dosage, and the lack of specific intervention parameters.

In the Italian rehabilitation landscape, rehabilitation technologies have been included in the Essential Levels of Care (LEA) of the National Health Service (SSN) since 2018 (9), promoting their adoption in clinical practice across accredited healthcare facilities. In this context, the Ausl Piacenza-Fiorenzuola Hospital represents a consolidated example of integration of technologies within rehabilitation pathways for patients with neurological conditions (e.g., stroke, spinal cord injury, traumatic brain injury). Technology-based treatments are delivered as adjuncts to conventional interventions, such as physiotherapy, hydrotherapy, occupational therapy, speech therapy, and neuropsychology, with the aim of enhancing rehabilitation effectiveness and addressing patients' functional needs.

For upper limb rehabilitation, four complementary devices are currently available:

* Intensive Visual Stimulation - IVS3 (Dessintey Co., France), a system for mirror therapy and motor imagery targeting motor planning and movement control; * Gloreha Professional 2 + Active Package (BTL Robotics, Italy), a soft robotic glove for hand rehabilitation; * PABLO® (Tyromotion, Austria), a multifunctional rehabilitation device based on sensors and interactive interfaces; * DIEGO® (Tyromotion, Austria), an end-effector device designed for assistive and interactive therapies.

In light of current evidence and the rehabilitation context of Fiorenzuola Hospital, the aim of this preliminary study is to evaluate the effect of a personalized technology-based treatment approach on upper limb motor function and capacity recovery in PwS.

Primary Objective The primary objective of the study is to estimate the expected effect of technology-based rehabilitation on upper limb recovery in adults with stroke.

Secondary Objective The secondary objective is to estimate technology-induced changes through instrumental assessments and explore their relationship with clinical outcomes.

Primary Endpoint The primary endpoint is the improvement in upper limb motor function and capacity, measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and the Action Research Arm Test (ARAT).

Clinically meaningful improvement is defined as reaching the Minimal Clinically Important Difference (MCID) of:

* 10 points on the FMA-UE (10) * 12 points on the ARAT (11)

The secondary endpoint is the improvement in active range of motion and grasp and pinches strength, assessed instrumentally using the PABLO® system (Tyromotion, Austria).

Statistical Analysis Plan

The distributions of the variables will be tested using the Shapiro-Wilk test. Depending on the distributional properties, the data will be summarised and described using the mean and standard deviation or the median and interquartile range. To assess the comparison between measurements taken before and after the intervention, either the Student's t-test for paired samples (normal distribution) or the Wilcoxon signed-rank test (non-normal distribution) will be used. The effect size will be calculated for the FMA-UE and ARAT scales using Cohen's d. In order to explore the relationships between rehabilitation dosage and motor recovery of the upper limb, correlation tests will be carried out. In particular, the Pearson correlation coefficient (or Spearman's in the case of non-normal distributions) will be calculated between the quantitative measures of rehabilitation dose (e.g. number of sessions, total hours of treatment) and functional improvement, measured by the change in scores: (ΔFMA-UE) and (ΔARAT).

The analyses will be conducted using STATA software, with a significance level set at p\<0.05. Any missing data for the observed variables may be handled using multiple imputation.

• Instrumented Active Range of Motion (AROM) of affected Upper Limb [Срок оценки: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)]
• Instrumental gross and fine motor grip strength of hand affected [Срок оценки: Baseline (T0) at enrollment, and after 4-5 weeks of observation (T1)]