Consciousness Disorders
Conditions
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.
Interventions
OTHERErigo + Silence
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with Erigo (3/week for 5 consecutive weeks), without auditory stimulation.
OTHERErigo + Metronome
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with Erigo (3/week for 5 consecutive weeks) and metronome stimulation.
OTHERErigo + Music
The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with Erigo (3/week for 5 consecutive weeks) and musical stimulation.
Sponsors
Ospedale Generale Di Zona Moriggia-Pelascini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in Coma Recovery Scale revised score | 0 and 35 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactGiuseppe Frazzitta, MD
Outcome results
None listed