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The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Equistasi
Placebo
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Focal Vibrations, Neurorehabilitation, Spasticity, Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prof. Giuseppe Orefice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Equistasi Group

Placebo Group

Arm Description

arm treated with application of devices

arm treated with application of inactivated devices

Outcomes

Primary Outcome Measures

Gait Velocity
evaluation of gait velocity in m/s
First step length
first step length in cm
Swing phase
swing phase measured in seconds
Stance phase
stance phase measured in seconds
Double support time
double support time measured in seconds

Secondary Outcome Measures

H/M ratio
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
Evaluation of balance with a self administered scale, measured in Unit
Modified Fatigue Scale
evaluation of fatigue with a self administered scale, measured in Unit

Full Information

First Posted
July 22, 2016
Last Updated
July 26, 2016
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02848898
Brief Title
The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Focal Vibrations, Neurorehabilitation, Spasticity, Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Equistasi Group
Arm Type
Experimental
Arm Description
arm treated with application of devices
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
arm treated with application of inactivated devices
Intervention Type
Device
Intervention Name(s)
Equistasi
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Gait Velocity
Description
evaluation of gait velocity in m/s
Time Frame
one year
Title
First step length
Description
first step length in cm
Time Frame
one year
Title
Swing phase
Description
swing phase measured in seconds
Time Frame
one year
Title
Stance phase
Description
stance phase measured in seconds
Time Frame
one year
Title
Double support time
Description
double support time measured in seconds
Time Frame
one year
Secondary Outcome Measure Information:
Title
H/M ratio
Description
evaluation of neurophysiological modifications in treated patients vs placebo group, as ratio between H max and M max in tibial posterior nerve, in Unit
Time Frame
one year
Title
Berg Balance Scale
Description
Evaluation of balance with a self administered scale, measured in Unit
Time Frame
one year
Title
Modified Fatigue Scale
Description
evaluation of fatigue with a self administered scale, measured in Unit
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Prof. Giuseppe Orefice
City
Naples
State/Province
Campania
ZIP/Postal Code
81025
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

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