Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163878
Status:
UNKNOWN
Last Update Posted:
2006-10-04
First Post:
2005-09-12
Brief Title:
Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
A Randomised Control Trial to Determine the Effectiveness of Sensory Stimulation Program in Reducing the Length of Time Spent by Severely Brain Injured Patients in a Vegetative State in the Acute Hospital Environment
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state The experimental group would receive in addition to their normal occuaptional therapy sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique SMART
Detailed Description:
A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state The experimental group would receive in addition to their normal occupational therapy sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique SMART
The SMART is both an assessment and treatment too Patients in both groups will have baseline assessments conducted using the SMART with further assessments conducted every ten days for thrity days The SMART is designed to provide quantitative data in the assessment of the patients cognitive function and potential awareness It is a five point hierarchical scale from level 1 no response to level 5 discriminating
The SMART is both an assessment and treatment too Patients in both groups will have baseline assessments conducted using the SMART with further assessments conducted every ten days for thrity days The SMART is designed to provide quantitative data in the assessment of the patients cognitive function and potential awareness It is a five point hierarchical scale from level 1 no response to level 5 discriminating
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None