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Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness

NCT ID: NCT02714491

Last Updated: 2016-09-30

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.

Detailed Description

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Conditions

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Consciousness Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Music

Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music

Group Type ACTIVE_COMPARATOR

Erigo + Music

Intervention Type OTHER

The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and musical stimulation.

Metronome

Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement)

Group Type ACTIVE_COMPARATOR

Erigo + Metronome

Intervention Type OTHER

The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and metronome stimulation.

Silence

Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation.

Group Type ACTIVE_COMPARATOR

Erigo + Silence

Intervention Type OTHER

The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks), without auditory stimulation.

Interventions

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Erigo + Music

The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and musical stimulation.

Intervention Type OTHER

Erigo + Metronome

The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and metronome stimulation.

Intervention Type OTHER

Erigo + Silence

The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks), without auditory stimulation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Vegetative State or Minimally Conscious State diagnosis
* \>3 months from acute brain injury

Exclusion Criteria

* No clinical stability
* Sepsis
* Orthopaedic contraindications for verticalization
* Deep Vein Thrombosis
* weight \>130 Kg
* height \>210 cm
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role lead

Responsible Party

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Ilaria Zivi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale Generale di Zona Moriggia Pelascini

Gravedona Ed Uniti, CO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Frazzitta, MD

Role: CONTACT

Phone: +39034492111

Email: [email protected]

Facility Contacts

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Giuseppe Frazzitta, MD

Role: primary

Other Identifiers

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Erigo.stim

Identifier Type: -

Identifier Source: org_study_id