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| Name | Class |
|---|---|
| Azienda Ospedaliero, Universitaria Pisana | OTHER |
| Villa Beretta Rehabilitation Center | OTHER |
| Fondazione Don Carlo Gnocchi ETS | OTHER |
| Ospedale Policlinico San Martino |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left hemisphere lesion group | Experimental | The stroke patients with left hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment |
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| Right hemisphere lesion group | Experimental | The stroke patients with right hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral robotic treatment for the upper limbs | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Fugl-Meyer for the upper limb functional scale (UEFM) | The scale ranges from 0 to 66, with higher scores indicating better performance | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Bimanual Activity Test scale (BAT) | The scale ranges from 0 to 100, with higher scores indicating better performance | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| Changes in the modified Ashworth scale (MAS) |
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Inclusion Criteria:
Exclusion Criteria:
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all IPD that underlie results in a publication
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
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| Standard physiotherapy | Behavioral | 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. |
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The scale ranges from 0 to 6, with lower scores indicating better performance |
| From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| Changes in the Stroke Impact Scale (SIS) | The scale ranges from 0 to 100, with higher scores indicating better performance | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| Changes in the Visual Analogue Scale (VAS) | The scale ranges from 0 to 10, with higher scores indicating higher pain | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| Changes in the Quick Dash scale | The scale ranges from 0 to 100, with higher scores indicating higher level of disability | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| Changes in weighted Phase Lag Index (wPLI) cortico-cortical brain connectivity (EEG) | The investigators will be measuring variations in the weighted Phase Lag Index (wPLI) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| Changes in weighted Symbolic Mutual Information (wSMI) cortico-cortical brain connectivity (EEG) | The investigators will be measuring variations in the weighted Symbolic Mutual Information (wSMI) | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| Changes in muscular synergies (EMG) | The investigators wil be measuring changes in muscle synergy patterns using the non-negative matrix factorization (NMF) algorithm | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| Changes in kinematic movement smoothness (SPARC) | The investigators will measure changes in movement smoothness using the SPARC parameter | From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |