The Effects of Focal Vibration on Spasticity in Multiple Sclerosis Patients

NCT02848898 | Unknown DMC

• 1 other identifier: 71/15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Focal Vibrations; Neurorehabilitation; Spasticity; Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• Gait Velocity

  evaluation of gait velocity in m/s

  one year

• First step length

  first step length in cm

  one year

• Swing phase

  swing phase measured in seconds

  one year

• Stance phase

  stance phase measured in seconds

  one year

• Double support time

  double support time measured in seconds

  one year

Secondary Outcomes (3)

• H/M ratio

  one year

• Berg Balance Scale

  one year

• Modified Fatigue Scale

  one year

Study Arms (2)

Equistasi Group

EXPERIMENTAL

arm treated with application of devices

Device: Equistasi

Placebo Group

PLACEBO COMPARATOR

arm treated with application of inactivated devices

Other: Placebo

Interventions

Equistasi DEVICE

Equistasi Group

Placebo OTHER

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple Sclerosis affected
• Spasticity
• EDSS (Expanded Disability Status Scale) 0 - 5,5
• Patients able to sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Prof. Giuseppe Orefice

Naples, Campania, 81025, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 29, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)