Traumatic Brain Injury and Stroke Long Term Outcome

Sponsor
Centre for Neuro Skills (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03399929
Collaborator
(none)
240
1
144
1.7

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Primary Completion Date :
May 4, 2026
Anticipated Study Completion Date :
May 4, 2028

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Effects of rehabilitation on long term occupational Status after injury [1 to 10 years]

    Occupational Status Questionnaire

  2. Effects of rehabilitation on long term cognitive function after injury [1 to 10 years]

    Brief Test of Adult Cognition by Telephone

  3. Effects of rehabilitation on long term disability function after injury [1 to 10 years]

    Supervision Rating Scale and Disability Rating Scale

  4. Effects of rehabilitation on long term quality of life after injury [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 [1 to 10 years]

    TBI and Health in Adults Questionnaire

Other Outcome Measures

  1. Effects of rehabilitation on post mortem health after injury [1 to 10 years]

    Post- Mortem health Assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

    1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Neuro Skills Encino California United States 91436

Sponsors and Collaborators

  • Centre for Neuro Skills

Investigators

  • Principal Investigator: Grace S Griesbach, PhD, Centre for Neuro Skills

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre for Neuro Skills
ClinicalTrials.gov Identifier:
NCT03399929
Other Study ID Numbers:
  • LTO1
First Posted:
Jan 17, 2018
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022