Stroke
Conditions
Brief summary
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
Interventions
DEVICEBilateral robotic treatment for the upper limbs
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.
BEHAVIORALStandard physiotherapy
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.
Sponsors
University of Pisa
Azienda Ospedaliero, Universitaria Pisana
Villa Beretta Rehabilitation Center
Fondazione Don Carlo Gnocchi Onlus
Ospedale Policlinico San Martino
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Fugl-Meyer for the upper limb functional scale (UEFM) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The scale ranges from 0 to 66, with higher scores indicating better performance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Bimanual Activity Test scale (BAT) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The scale ranges from 0 to 100, with higher scores indicating better performance |
| Changes in the modified Ashworth scale (MAS) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The scale ranges from 0 to 6, with lower scores indicating better performance |
| Changes in the Stroke Impact Scale (SIS) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The scale ranges from 0 to 100, with higher scores indicating better performance |
| Changes in the Visual Analogue Scale (VAS) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The scale ranges from 0 to 10, with higher scores indicating higher pain |
| Changes in the Quick Dash scale | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The scale ranges from 0 to 100, with higher scores indicating higher level of disability |
| Changes in weighted Phase Lag Index (wPLI) cortico-cortical brain connectivity (EEG) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The investigators will be measuring variations in the weighted Phase Lag Index (wPLI) |
| Changes in weighted Symbolic Mutual Information (wSMI) cortico-cortical brain connectivity (EEG) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The investigators will be measuring variations in the weighted Symbolic Mutual Information (wSMI) |
| Changes in muscular synergies (EMG) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The investigators wil be measuring changes in muscle synergy patterns using the non-negative matrix factorization (NMF) algorithm |
| Changes in kinematic movement smoothness (SPARC) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 | The investigators will measure changes in movement smoothness using the SPARC parameter |
Outcome results
None listed