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Clinical Trials/NCT02848898
NCT02848898UnknownNot Applicable

The Effects of Focal Vibration on Central and Peripheral Spasticity in Multiple Sclerosis Patients. A Randomized, Multicenter, Double Blinded vs Placebo Study

Federico II University2 sites in 1 country60 target enrollmentStarted: August 1, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Double support time
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Double support time

Time Frame: one year

double support time measured in seconds

Stance phase

Time Frame: one year

stance phase measured in seconds

Gait Velocity

Time Frame: one year

evaluation of gait velocity in m/s

First step length

Time Frame: one year

first step length in cm

Swing phase

Time Frame: one year

swing phase measured in seconds

Secondary Outcomes

  • Berg Balance Scale(one year)
  • H/M ratio(one year)
  • Modified Fatigue Scale(one year)

Investigators

Sponsor
Federico II University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emanuele Spina

Resident

Federico II University

Study Sites (2)

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