The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

July 26, 2016 updated by: Emanuele Spina, Federico II University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Campania
      • Naples, Campania, Italy, 81025
        • Prof. Giuseppe Orefice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Equistasi Group
arm treated with application of devices
Device: Equistasi
Placebo Comparator: Placebo Group
arm treated with application of inactivated devices
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Velocity
Time Frame: one year
evaluation of gait velocity in m/s
one year
First step length
Time Frame: one year
first step length in cm
one year
Swing phase
Time Frame: one year
swing phase measured in seconds
one year
Stance phase
Time Frame: one year
stance phase measured in seconds
one year
Double support time
Time Frame: one year
double support time measured in seconds
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H/M ratio
Time Frame: 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
one year
Berg Balance Scale
Time Frame: one year
Evaluation of balance with a self administered scale, measured in Unit
one year
Modified Fatigue Scale
Time Frame: one year
evaluation of fatigue with a self administered scale, measured in Unit
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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