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This trial consists of application of little devices (named Equistasi®) generating focal vibrations to treat spasticity in neurological patients, affected by multiple sclerosis. The expected effects are on gait and postural instability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Equistasi Group | Experimental | arm treated with application of devices |
|
| Placebo Group | Placebo Comparator | arm treated with application of inactivated devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equistasi | Device |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Velocity | evaluation of gait velocity in m/s | one year |
| First step length | first step length in cm | one year |
| Swing phase | swing phase measured in seconds | one year |
| Stance phase | stance phase measured in seconds | one year |
| Double support time | double support time measured in seconds | one year |
| Measure | Description | Time Frame |
|---|---|---|
| H/M ratio | evaluation of neurophysiological modifications in treated patients vs placebo group, as ratio between H max and M max in tibial posterior nerve, in Unit | one year |
| Berg Balance Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Giuseppe Orefice | Naples | Campania | 81025 | Italy |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
Evaluation of balance with a self administered scale, measured in Unit
| one year |
| Modified Fatigue Scale | evaluation of fatigue with a self administered scale, measured in Unit | one year |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |