Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 10, 2016
CompletedFirst Posted
Study publicly available on registry
March 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedSeptember 30, 2016
September 1, 2016
2 years
March 10, 2016
September 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
change in Coma Recovery Scale revised score
0 and 35 days
Secondary Outcomes (4)
change in Levels of Cognitive Functioning score
0 and 35 days
change in Disability Rating Scale score
0 and 35 days
change in quantitative EEG parameters
0 and 35 days
change in Glasgow Coma Scale score
0 and 35 days
Study Arms (3)
Music
ACTIVE COMPARATORErigo + Music: During each stepping verticalization session the patient receives auditory stimulation (earphones) with previously preferred music
Metronome
ACTIVE COMPARATORErigo + Metronome: During each stepping verticalization session the patient receives auditory stimulation (earphones) with a metronome (rhythmic with the stepping movement)
Silence
ACTIVE COMPARATORErigo + Silence: During each stepping verticalization session the patient does note receive any auditory stimulation.
Interventions
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and musical stimulation.
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks) and metronome stimulation.
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with "Erigo" (3/week for 5 consecutive weeks), without auditory stimulation.
Eligibility Criteria
You may qualify if:
- Vegetative State or Minimally Conscious State diagnosis
- \>3 months from acute brain injury
You may not qualify if:
- No clinical stability
- Sepsis
- Orthopaedic contraindications for verticalization
- Deep Vein Thrombosis
- weight \>130 Kg
- height \>210 cm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale Generale di Zona Moriggia Pelascini
Gravedona Ed Uniti, CO, 22015, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 10, 2016
First Posted
March 21, 2016
Study Start
June 1, 2015
Primary Completion
June 1, 2017
Last Updated
September 30, 2016
Record last verified: 2016-09