The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

Federico II University

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Device: Equistasi; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02848898

71/15

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Equistasi Group

Experimental group

Description:

arm treated with application of devices

Treatment:

Device: Equistasi

Placebo Group

Placebo Comparator group

Description:

arm treated with application of inactivated devices

Treatment:

Other: Placebo