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The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

NCT ID: NCT02848898

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Focal Vibrations Neurorehabilitation Spasticity Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Equistasi Group

arm treated with application of devices

Group Type EXPERIMENTAL

Equistasi

Intervention Type DEVICE

Placebo Group

arm treated with application of inactivated devices

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Equistasi

Intervention Type DEVICE

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Emanuele Spina

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prof. Giuseppe Orefice

Naples, Campania, Italy

Site Status

Countries

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Italy

Other Identifiers

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71/15

Identifier Type: -

Identifier Source: org_study_id