Sensory and Cognitive Outcomes of Robotic Exercises in Stroke (SCORES)

The study aims to investigate whether an upper limb robotic treatment could have a greater impact than a conventional approach on specific cognitive domains in patients with stroke, as well as in restoring the somatosensory impairment in patients with stroke.

For this aim, 126 consecutive subjects with stroke in the sub-acute phase (within 6 months after stroke) will be enrolled and randomized to either the robotic (RG) or the conventional group (CG). The sample size was calculated by means of a 2- sided, 2-sample t-test assuming: 80% power; type I error of 0.05; a mean difference of 2.15 units on the MoCA, a common standard deviation of 3.77 points (Wu 2019). Considering a dropout rate of 20%, the final sample size required was estimated to be 126 subjects.

Randomization will be stratified according to a cut-off of 18.28 on the MoCA demographically adjusted total score (inner confidence limit of the 5th centile of the normal population) indicating a borderline performance, to ensure that the subjects' characteristics in each group will be closely matched. In the RG, patients will undergo robotic therapy, while a conventional approach will be used in the CG. The rehabilitation treatments, either robotic or conventional, will be performed daily for 45 minutes, 5 days/week, for a total of 30 sessions. Patients in the RG will be treated using a set of devices that allow bi- and three-dimensional movements of the shoulder, elbow, wrist, and fingers (Aprile et al, 2019). Motor and cognitive tasks, carefully selected among those available, will be performed during the treatment, following a protocol already proposed in a previous pilot study (Aprile et al, 2021). Visual and auditory feedback will be provided to help the patients. In the RG, treatment will focus on reprogramming sensorimotor function, hypertonus inhibition, and functional improvement. Patients will be evaluated at baseline (T0), the end of the rehabilitation protocol (T1), and a 6-month follow-up (T2).

• Changes in Montreal Cognitive Assessment [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Symbol Digit Modalities Test [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Tower of London [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Rey-Osterrieth Complex Figure test [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Visual search test [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Fugl-Meyer Assessment of the Upper Extremity (motor score) [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Thumb Localizing Test [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Semmes Weinstein filament test [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Fugl-Meyer Assessment of the Upper Extremity (sensation score) [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Box and Block test [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Motricity Index [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]
• Changes in Modified Barthel Index [Срок оценки: Baseline, up to 7 days after the enrollment; up to 3 days after the intervention; 6 months after the end of the intervention]