The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Other: Placebo; Device: Equistasi

• Registration Number: NCT02848898
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-29
• Last Update Posted: 2016-07-29
• Study Start: 2016-08
• Primary Completion: 2017-05
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	arm treated with application of inactivated devices
Equistasi Group	Equistasi	arm treated with application of devices

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	one year	Evaluation of balance with a self administered scale, measured in Unit
H/M ratio	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
Modified Fatigue Scale	one year	evaluation of fatigue with a self administered scale, measured in Unit

Trial Locations

Locations (1)

Prof. Giuseppe Orefice; 🇮🇹 Naples, Campania, Italy