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| Name | Class |
|---|---|
| Universitat Politècnica de València | OTHER |
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Precise description of behavioral signs denoting transition from unresponsive wakefulness syndrome/vegetative state (UWS/VS) to minimally conscious state (MCS) or emergence from MCS after severe brain injury is crucial for prognostic purposes. A few studies have attempted this goal but involved either non-standardized instruments, limited temporal accuracy or samples, or focused on (sub)acute patients. The objective of this study is to describe the behavioral signs that led to a change of diagnosis, as well as the factors influencing this transition, in a large sample of patients with chronic disorders of consciousness after severe brain injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disorders of consciousness | Patients diagnosed as either in a Vegetative State or in a Minimally Conscious State |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Behavioral | Multidisciplinary rehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline score in the Coma Recovery Scale-Revised until study completion | The Coma Recovery Scale-Revised consists of 29 hierarchically organised items divided into 6 subscales addressing auditory, visual, motor, oromotor, communication, and arousal processes. | From inclusion in the study until discharge or death, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline score in the Functional Independence Measure until study completion | The Functional Independence Measure is an 18-item measurement tool that explores an individual's physical, psychological and social function | From inclusion in the study until discharge or death, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants were subjects who were diagnosed as with UWS or in a MCS after a brain injury
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Noé | Hospitales Nisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA | Valencia | 46011 | Spain |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Change from baseline score in the Disability Rating Scale until study completion |
The Disability Rating Scale is an 8-item measure that assesses disability of individuals with moderate to severe traumatic brain injury at a wide range of functional levels from coma through community living |
| rom inclusion in the study until discharge or death, assessed up to 24 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |