Back to resultsEffects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness
Primary Purpose
Consciousness Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Erigo + Music
Erigo + Metronome
Erigo + Silence
Sponsored by
About this trial
This is an interventional supportive care trial for Consciousness Disorders
Eligibility Criteria
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
Sites / Locations
- Ospedale Generale di Zona Moriggia PelasciniRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Music
Metronome
Silence
Arm Description
Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music
Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement)
Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation.
Outcomes
Primary Outcome Measures
change in Coma Recovery Scale revised score
Secondary Outcome Measures
change in Levels of Cognitive Functioning score
change in Disability Rating Scale score
change in quantitative EEG parameters
change in Glasgow Coma Scale score
Full Information
NCT ID
NCT02714491
First Posted
March 10, 2016
Last Updated
September 29, 2016
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
1. Study Identification
Unique Protocol Identification Number
NCT02714491
Brief Title
Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Consciousness Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music
Arm Type
Active Comparator
Arm Description
Erigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music
Arm Title
Metronome
Arm Type
Active Comparator
Arm Description
Erigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement)
Arm Title
Silence
Arm Type
Active Comparator
Arm Description
Erigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation.
Intervention Type
Other
Intervention Name(s)
Erigo + Music
Intervention Description
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
Intervention Name(s)
Erigo + Metronome
Intervention Description
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
Intervention Name(s)
Erigo + Silence
Intervention Description
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks), without auditory stimulation.
Primary Outcome Measure Information:
Title
change in Coma Recovery Scale revised score
Time Frame
0 and 35 days
Secondary Outcome Measure Information:
Title
change in Levels of Cognitive Functioning score
Time Frame
0 and 35 days
Title
change in Disability Rating Scale score
Time Frame
0 and 35 days
Title
change in quantitative EEG parameters
Time Frame
0 and 35 days
Title
change in Glasgow Coma Scale score
Time Frame
0 and 35 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Frazzitta, MD
Phone
+39034492111
Email
frazzittag62@gmail.com
Facility Information:
Facility Name
Ospedale Generale di Zona Moriggia Pelascini
City
Gravedona ed Uniti
State/Province
CO
ZIP/Postal Code
22015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Phone
+39034492111
Email
frazzittag62@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness
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