Multiple Sclerosis
Conditions
Keywords
Focal Vibrations, Neurorehabilitation, Spasticity, Multiple Sclerosis
Brief summary
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.
Interventions
DEVICEEquistasi
OTHERPlacebo
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Multiple Sclerosis affected * Spasticity * EDSS (Expanded Disability Status Scale) 0 - 5,5 * Patients able to sign informed consent
Exclusion criteria
* Age less than 18 years old and more than 65 years old * Pacemaker * Pregnancy * Comorbidities as: cancer, hypertension not controlled by drugs * concurrent therapies with antidepressant or corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Double support time | one year | double support time measured in seconds |
| First step length | one year | first step length in cm |
| Swing phase | one year | swing phase measured in seconds |
| Stance phase | one year | stance phase measured in seconds |
| Gait Velocity | one year | evaluation of gait velocity in m/s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| H/M ratio | one year | evaluation of neurophysiological modifications in treated patients vs placebo group, as ratio between H max and M max in tibial posterior nerve, in Unit |
| Berg Balance Scale | one year | Evaluation of balance with a self administered scale, measured in Unit |
| Modified Fatigue Scale | one year | evaluation of fatigue with a self administered scale, measured in Unit |
Countries
Italy
Outcome results
None listed