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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
Sponsor:
Information provided by (Responsible Party):
Centre for Neuro Skills

Brief Summary:
Investigators will determine the long-lasting effects of post-acute rehabilitation after traumatic brain injury and stroke. Investigators will also evaluate if the beneficial effects of rehabilitation continue after discharge from a rehabilitative program.

Condition or disease Intervention/treatment
Traumatic Brain Injury Stroke Other: Post Acute Rehabiltation

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Effects of rehabilitation on long term occupational Status after injury [ Time Frame: 1 to 10 years ]
    Occupational Status Questionnaire

  2. Effects of rehabilitation on long term cognitive function after injury [ Time Frame: 1 to 10 years ]
    Brief Test of Adult Cognition by Telephone

  3. Effects of rehabilitation on long term disability function after injury [ Time Frame: 1 to 10 years ]
    Supervision Rating Scale and Disability Rating Scale

  4. 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)


Secondary Outcome Measures :
  1. Effects of rehabilitation on long term health after injury [ Time Frame: 1 to 10 years ]
    TBI and Wealth in Adults Questionnaire


Other Outcome Measures:
  1. Effects of rehabilitation on post mortem health after injury [ Time Frame: 1 to 10 years ]
    Post- Mortem health Assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects with a traumatic brain injury or stroke
Criteria

Inclusion Criteria:

  • Endured a traumatic brain injury or stroke
  • Subject or caretaker should be Fluent in English

Exclusion Criteria:

  • Diagnosis of degenerative neurological disease prior to sustaining stroke or traumatic brain injury
  • b) A history of major psychosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) prior to sustaining stroke or traumatic brain injury

Information from the National Library of Medicine

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


Contacts
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Contact: Grace S Griesbach, PhD (818)783-3800 researchcentre@neuroskills.com
Contact: Stefanie Howell, PhD (972)580-8500 showell@neuroskills.com

Locations
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United States, California
Centre for Neuro Skills Recruiting
Encino, California, United States, 91436
Contact: Grace S Griesbach, PhD    818-783-3800    researchcentre@neuroskills.com   
Contact: Stefanie Howell, PhD    (972)580-8500    showell@neuroskills.com   
Sponsors and Collaborators
Centre for Neuro Skills
Investigators
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Principal Investigator: Grace S Griesbach, PhD Centre for Neuro Skills

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Responsible Party: Centre for Neuro Skills
ClinicalTrials.gov Identifier: NCT03399929     History of Changes
Other Study ID Numbers: LTO1
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre for Neuro Skills:
Rehabilitation
Long term outcome

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Stroke
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases