Clinical trial NCT03399929: Traumatic Brain Injury and Stroke Long Term Outcome
Official title: Effects of Rehabilitation Following Traumatic Brain Injury and Stroke: A Long Term Outcome Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Stroke
Keywords: Rehabilitation
Long term outcome
Lead sponsor: Centre for Neuro Skills
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects with a traumatic brain injury or stroke

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.

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

Primary outcomes:
measure: Effects of rehabilitation on long term occupational Status after injury
timeFrame: 1 to 10 years
measure: Effects of rehabilitation on long term cognitive function after injury
timeFrame: 1 to 10 years
measure: Effects of rehabilitation on long term disability function after injury
timeFrame: 1 to 10 years
measure: Effects of rehabilitation on long term quality of life after injury
timeFrame: 1 to 10 years
Secondary outcomes:
measure: Effects of rehabilitation on long term health after injury
timeFrame: 1 to 10 years
Other outcomes:
measure: Effects of rehabilitation on post mortem health after injury
timeFrame: 1 to 10 years
Locations:
city: Encino
country: United States
facility: Centre for Neuro Skills
state: California
Study officials:
affiliation: Centre for Neuro Skills
name: Grace S Griesbach, PhD
role: PRINCIPAL_INVESTIGATOR
References: