Traumatic Brain Injury and Stroke Long Term Outcome
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|ClinicalTrials.gov Identifier: NCT03399929|
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 30, 2018
|Condition or disease||Intervention/treatment|
|Traumatic Brain Injury Stroke||Other: Post Acute Rehabiltation|
The long-term effects of rehabilitation will be evaluated on 60 patients with traumatic brain injury (TBI) and 60 patients that suffered a cerebrovascular accident (CVA) that underwent an comprehensive rehabilitative. These patients will be matched with subjects that received limited or no rehabilitation rehabilitative therapy. Thus, the total number of subjects in this study will be 240. Subjects will be contacted at least 1 year after discharge and will be lowed up every two-years thereafter for a total period of 10 years. Procedures will be performed in-person whenever possible. However, it is highly likely that the majority of participants will be contacted via phone interviews.
Aim 1: Determine if rehabilitation improves vocational status and living status after TBI and CVA.
Aim 2: Determine if rehabilitation improves life quality after TBI and CVA.
Aim 3: Determine if rehabilitation improves cognitive function after TBI and CVA.
Aim 4: Determine if rehabilitative benefits are sustained.
Aim 5: Determine if long-term outcome is dependent on the duration of rehabilitation.
Aim 6: Determine if long-term outcome is dependent on the nature of the rehabilitative treatment by comparing the effects of different types of rehabilitation. These will include the following: residential-multidisciplinary, day-treatment (i.e. full time multidisciplinary outpatient), outpatient (part-time), skilled nursing and no post-acute rehabilitation.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Effects of Rehabilitation Following Traumatic Brain Injury and Stroke: A Long Term Outcome Study.|
|Actual Study Start Date :||May 4, 2016|
|Estimated Primary Completion Date :||May 4, 2026|
|Estimated Study Completion Date :||May 4, 2028|
TBI + Rehabilitation
Traumatic Brain Injury patients that received post acute rehabilitation
Other: Post Acute Rehabiltation
TBI + No Rehabilitation
Traumatic Brain Injury patients that did not receive post acute rehabilitation
CVA + Rehabilitation
Stroke patients that received post acute rehabilitation
Other: Post Acute Rehabiltation
CVA + No Rehabilitation
Stroke patients that did not received post acute rehabilitation
- Effects of rehabilitation on long term occupational Status after injury [ Time Frame: 1 to 10 years ]Occupational Status Questionnaire
- Effects of rehabilitation on long term cognitive function after injury [ Time Frame: 1 to 10 years ]Brief Test of Adult Cognition by Telephone
- Effects of rehabilitation on long term disability function after injury [ Time Frame: 1 to 10 years ]Supervision Rating Scale and Disability Rating Scale
- Effects of rehabilitation on long term quality of life after injury [ Time Frame: 1 to 10 years ]Quality of Life in Neurological Disorders Measures (NeuroQOL)
- Effects of rehabilitation on long term health after injury [ Time Frame: 1 to 10 years ]TBI and Wealth in Adults Questionnaire
- Effects of rehabilitation on post mortem health after injury [ Time Frame: 1 to 10 years ]Post- Mortem health Assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399929
|Contact: Grace S Griesbach, PhD||(818)email@example.com|
|Contact: Stefanie Howell, PhD||(972)firstname.lastname@example.org|
|United States, California|
|Centre for Neuro Skills||Recruiting|
|Encino, California, United States, 91436|
|Contact: Grace S Griesbach, PhD 818-783-3800 email@example.com|
|Contact: Stefanie Howell, PhD (972)580-8500 firstname.lastname@example.org|
|Principal Investigator:||Grace S Griesbach, PhD||Centre for Neuro Skills|