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Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music | Active Comparator | Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music |
|
| Metronome | Active Comparator | Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement) |
|
| Silence | Active Comparator | Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erigo + Music | Other | The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and musical stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| change in Coma Recovery Scale revised score | 0 and 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| change in Levels of Cognitive Functioning score | 0 and 35 days | |
| change in Disability Rating Scale score | 0 and 35 days | |
| change in quantitative EEG parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Frazzitta, MD | Contact | +39034492111 | frazzittag62@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Generale di Zona Moriggia Pelascini | Recruiting | Gravedona Ed Uniti | CO | 22015 | Italy |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Erigo + Metronome | Other | The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and metronome stimulation. |
|
| Erigo + Silence | Other | The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks), without auditory stimulation. |
|
| 0 and 35 days |
| change in Glasgow Coma Scale score | 0 and 35 days |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |