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The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

This study is not yet open for participant recruitment.
Verified July 2016 by Emanuele Spina, Federico II University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02848898
First Posted: July 29, 2016
Last Update Posted: July 29, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Emanuele Spina, Federico II University
  Purpose
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 Intervention
Multiple Sclerosis Device: Equistasi Other: Placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Emanuele Spina, Federico II University:

Primary Outcome Measures:
  • 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

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

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


Secondary Outcome Measures:
  • 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

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

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


Estimated Enrollment: 60
Study Start Date: August 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Equistasi Group
arm treated with application of devices
Device: Equistasi
Placebo Comparator: Placebo Group
arm treated with application of inactivated devices
Other: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02848898


Locations
Italy
Prof. Giuseppe Orefice
Naples, Campania, Italy, 81025
Sponsors and Collaborators
Federico II University
  More Information

Responsible Party: Emanuele Spina, Resident, Federico II University
ClinicalTrials.gov Identifier: NCT02848898     History of Changes
Other Study ID Numbers: 71/15
First Submitted: July 22, 2016
First Posted: July 29, 2016
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
Neurorehabilitation
Spasticity
Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Muscle Spasticity
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