Efficacy of a Bilateral Robotic Treatment in Chronic Patients

N/ANot Yet RecruitingNCT07259876

University of Pisa60 enrolled

Overview

The goal of this clinical trial is to evaluate how manual dominance influences the effectiveness of bilateral robotic treatment in right-handed patients with chronic stroke. Researchers will compare the outcome of a bilateral robotic treatment for the upper limbs in left vs right hemisphere lesions following stroke. Participants will: * perform a bilateral robotic treatment for the upper limb (15 sessions in three weeks) followed by 20-minutes standard manual rehabilitative sessions * be evaluated before and after treatment with clinical scales, resting- state EEG and kinematic measurements

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke

Interventions

Bilateral robotic treatment for the upper limbsDEVICE

Patients will perform a specific sequence of exercises with the exoskeleton for the upper limbs ALEx-RS, including passive and active-assisted movements, unilateral and bilateral reaching tasks with visual feedback, and symmetric and asymmetric bimanual coordination tasks.

Standard physiotherapyBEHAVIORAL

After the robotic treatment, patients will undergo 20 minutes of conventional treatment consisting of passive and active-assisted mobilization with the help of a physiotherapist.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects aged between 18 and 80 years, of either sex * Subjects able to understand and provide, or have provided on their behalf, informed consent * History of a single unilateral ischemic or hemorrhagic cerebrovascular event in the chronic phase (\> 6 months) * Subjects with mild to moderate functional impairment of the right or left upper limb (ability to perform antigravity active movements) Exclusion Criteria: * Subjects with cognitive deficits that impair understanding of the required tasks (MMSE score corrected for age and education \< 24/30) * Subjects with severe visual deficits * Subjects with upper limb spasticity preventing the use of robotic devices (spasticity measured using the Modified Ashworth Scale \> 3) * Inability or unwillingness to provide informed consent * Left-handed subjects