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The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02848898
Recruitment Status : Unknown
Verified July 2016 by Emanuele Spina, Federico II University.
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Information provided by (Responsible Party):
Emanuele Spina, Federico II University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Equistasi Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Focal Vibration on Central and Peripheral Spasticity in Multiple Sclerosis Patients. A Randomized, Multicenter, Double Blinded vs Placebo Study
Study Start Date : August 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Gait Velocity [ Time Frame: one year ]
    evaluation of gait velocity in m/s

  2. First step length [ Time Frame: one year ]
    first step length in cm

  3. Swing phase [ Time Frame: one year ]
    swing phase measured in seconds

  4. Stance phase [ Time Frame: one year ]
    stance phase measured in seconds

  5. Double support time [ Time Frame: one year ]
    double support time measured in seconds

Secondary Outcome Measures :
  1. 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

  2. Berg Balance Scale [ Time Frame: one year ]
    Evaluation of balance with a self administered scale, measured in Unit

  3. Modified Fatigue Scale [ Time Frame: one year ]
    evaluation of fatigue with a self administered scale, measured in Unit

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02848898

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Prof. Giuseppe Orefice
Naples, Campania, Italy, 81025
Sponsors and Collaborators
Federico II University
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Responsible Party: Emanuele Spina, Resident, Federico II University Identifier: NCT02848898    
Other Study ID Numbers: 71/15
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Emanuele Spina, Federico II University:
Focal Vibrations
Multiple Sclerosis
Additional relevant MeSH terms:
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Muscle Spasticity
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms