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The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

F

Federico II University

Status

Unknown

Conditions

Multiple Sclerosis

Treatments

Device: Equistasi
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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