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NCT Number: NCT03399929

Traumatic Brain Injury and Stroke Long Term Outcome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post Acute Rehabiltation

Other

Primary outcomes

  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 outcomes

  1. Effects of rehabilitation on long term health after injury

    Time frame: 1 to 10 years

    TBI and Health in Adults Questionnaire

Other outcomes

  1. Effects of rehabilitation on post mortem health after injury

    Time frame: 1 to 10 years

    Post- Mortem health Assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Grace S Griesbach, PhD

CONTACT

[email protected]

(818)783-3800

Stefanie Howell, PhD

CONTACT

[email protected]

(972)580-8500

Sponsors and collaborators

Lead sponsor

Centre for Neuro Skills

Industry

Registry information

Official study title

Effects of Rehabilitation Following Traumatic Brain Injury and Stroke: A Long Term Outcome Study.

Important dates

Study start
2016
Primary completion
2026
Study completion
2028
First posted
Jan 17, 2018
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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