Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Traumatic Brain Injury and Stroke Long Term Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date January 8, 2018
First Posted Date January 17, 2018
Last Update Posted Date January 30, 2018
Actual Study Start Date May 4, 2016
Estimated Primary Completion Date May 4, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2018)
  • 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)
Original Primary Outcome Measures
 (submitted: January 8, 2018)
  • Effects of rehabilitation on long term occupational sStatus 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 ]
    NeuroQOL
Change History Complete list of historical versions of study NCT03399929 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 16, 2018)
Effects of rehabilitation on long term health after injury [ Time Frame: 1 to 10 years ]
TBI and Wealth in Adults Questionnaire
Original Secondary Outcome Measures
 (submitted: January 8, 2018)
Effects of rehabilitation on long term health after injury [ Time Frame: 1 to 10 years ]
MIDUS
Current Other Pre-specified Outcome Measures
 (submitted: January 8, 2018)
Effects of rehabilitation on post mortem health after injury [ Time Frame: 1 to 10 years ]
Post- Mortem health Assessment
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Traumatic Brain Injury and Stroke Long Term Outcome
Official Title Effects of Rehabilitation Following Traumatic Brain Injury and Stroke: A Long Term Outcome Study.
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult subjects with a traumatic brain injury or stroke
Condition
  • Traumatic Brain Injury
  • Stroke
Intervention Other: Post Acute Rehabiltation
Study Groups/Cohorts
  • TBI + Rehabilitation
    Traumatic Brain Injury patients that received post acute rehabilitation
    Intervention: 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
    Intervention: Other: Post Acute Rehabiltation
  • CVA + No Rehabilitation
    Stroke patients that did not received post acute rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 8, 2018)
240
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 4, 2028
Estimated Primary Completion Date May 4, 2026   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Grace S Griesbach, PhD (818)783-3800 researchcentre@neuroskills.com
Contact: Stefanie Howell, PhD (972)580-8500 showell@neuroskills.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03399929
Other Study ID Numbers LTO1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Centre for Neuro Skills
Study Sponsor Centre for Neuro Skills
Collaborators Not Provided
Investigators
Principal Investigator: Grace S Griesbach, PhD Centre for Neuro Skills
PRS Account Centre for Neuro Skills
Verification Date January 2018