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Clinical Trials/NCT00163878
NCT00163878
Unknown
Phase 4

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

Bayside Health2 sites in 1 countryNovember 2004

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Bayside Health
Locations
2
Primary Endpoint
Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups
Last Updated
19 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2004
End Date
December 2006
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bayside Health

Eligibility Criteria

Inclusion Criteria

  • admitted with severe brain injury
  • GCS of 9 or less. A GCS score of 9 or less is indicative of a severe brain injury
  • medically stable, as documented by medical staff
  • age 18 to 65 years
  • controlled intracranial pressure no sedation
  • no previous brain injury
  • Exclusion Criteria
  • patient declared brain dead
  • next of kin withdraws patient from the study
  • withdrawal of consent by patient on waking

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups

Secondary Outcomes

  • Fucntional status at six months, assessed using the modified Barthel

Study Sites (2)

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