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| Name | Class |
|---|---|
| Azienda USL Toscana Nord Ovest | OTHER |
| Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna | OTHER |
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This is a phase-II clinical study to assess whether intense passive mobilization of the elbow during the early stage is effective in preventing spasticity from occurring at a later stage. A group of subacute stroke patients was treated with the device named NEUROExos Elbow Module (NEEM) on a daily basis, in addition to traditional physical therapy. The outcome was assessed in terms of (i) system safety, (ii) system usability and (iii) treatment efficacy.
Investigators expected that intense therapy performed in the sub-acute phase following the stroke would be effective in preventing elbow spasticity from occurring at a later stage (i.e. 3-4 months after the stroke), the latter being quantified by means of the Modified Ashworth Scale (MAS). Similarly to other phase-II studies in the field of post-stroke rehabilitation, the present study will include only one group of patients. As a secondary objective, similarly to other studies with robot-assisted therapy, investigators wiil test the ability of this system to be used for assessing rehabilitation outcome. Investigators will introduce novel evaluation metrics based on the kinematics and kinetics variables recorded by the NEEM and compared them with MAS values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subacute stroke patients | Experimental | Elbow passive/active robotic treatment provided by NEUROExos Elbow Module |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic treatment | Device | Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale | Impairmente level maesure according to ICF | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion | Impairmente level maesure according to ICF | 2 weeks |
| Maximum Extension Torque | Paramenter directly exterted by the device |
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Exclusion Criteria:
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| 2 weeks |
| Zero-Torque Angle | Paramenter directly exterted by the device | 2 weeks |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |