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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02714491
Other study ID # Erigo.stim
Secondary ID
Status Recruiting
Phase N/A
First received March 10, 2016
Last updated September 29, 2016
Start date June 2015

Study information

Verified date September 2016
Source Ospedale Generale Di Zona Moriggia-Pelascini
Contact Giuseppe Frazzitta, MD
Phone +39034492111
Email frazzittag62@gmail.com
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
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.
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.
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.

Locations

Country Name City State
Italy Ospedale Generale di Zona Moriggia Pelascini Gravedona ed Uniti CO

Sponsors (1)

Lead Sponsor Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in Coma Recovery Scale revised score 0 and 35 days No
Secondary change in Levels of Cognitive Functioning score 0 and 35 days No
Secondary change in Disability Rating Scale score 0 and 35 days No
Secondary change in quantitative EEG parameters 0 and 35 days No
Secondary change in Glasgow Coma Scale score 0 and 35 days No
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