Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02848898
NCT02848898
Unknown
Not 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 University1 site in 1 country60 target enrollmentAugust 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsMultiple Sclerosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Federico II University
Enrollment
60
Locations
1
Primary Endpoint
Double support time
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
July 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Emanuele Spina

Resident

Federico II University

Eligibility Criteria

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)

Study Sites (1)

Loading locations...

Similar Trials

Not yet recruiting
Not Applicable
Focal Microvibration and Chronic Lumbosacral Radicular PainPain, ChronicLumbosacral RadiculopathyRadicular; Neuropathic
NCT06301061Federico II University150
Completed
Not Applicable
Vibratory Stimuli, A Novel Rehabilitation Method for Preventing Post - Traumatic Knee OsteoarthritisKnee Osteoarthritis
NCT02605876University of North Carolina, Chapel Hill75
Completed
Not Applicable
Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized PatientsCritically IllPost Intensive Care Syndrome
NCT03479008University of Michigan36
Withdrawn
Not Applicable
Testing of a New Therapeutic Vibration Device to Reduce Neuromuscular Weakness in Hospitalized Patients (Hospital Testing)Critically Ill
NCT05352100University of Michigan
Completed
Not Applicable
The Effect of Vibration Therapy on Pain, Functionality and Proprioception in İndividuals With Cervical Disc HerniationCervical Disc HerniationVibration TherapyPainFunctionalityProprioception
NCT06139263Medipol University44