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Traumatic Brain Injury and Stroke Long Term Outcome

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03399929
Enrollment
240
Registered
2018-01-17
Start date
2016-05-04
Completion date
2028-05-04
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Traumatic Brain Injury

Keywords

Rehabilitation, Long term outcome

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.

Interventions

OTHERPost Acute Rehabiltation

Sponsors

Centre for Neuro Skills
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Effects of rehabilitation on long term occupational Status after injury1 to 10 yearsOccupational Status Questionnaire
Effects of rehabilitation on long term cognitive function after injury1 to 10 yearsBrief Test of Adult Cognition by Telephone
Effects of rehabilitation on long term disability function after injury1 to 10 yearsSupervision Rating Scale and Disability Rating Scale
Effects of rehabilitation on long term quality of life after injury1 to 10 yearsQuality of Life in Neurological Disorders Measures (NeuroQOL)

Secondary

MeasureTime frameDescription
Effects of rehabilitation on long term health after injury1 to 10 yearsTBI and Health in Adults Questionnaire

Other

MeasureTime frameDescription
Effects of rehabilitation on post mortem health after injury1 to 10 yearsPost- Mortem health Assessment

Countries

United States

Contacts

Primary ContactGrace S Griesbach, PhD
researchcentre@neuroskills.com(818)783-3800
Backup ContactStefanie Howell, PhD
showell@neuroskills.com(972)580-8500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026