Traumatic Brain Injury and Stroke Long Term Outcome

Recruiting

• Conditions: Traumatic Brain Injury; Stroke
• Interventions: Other: Post Acute Rehabiltation

• Registration Number: NCT03399929
• Lead Sponsor: Centre for Neuro Skills

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 Timeline

• Study Start: 2016-05-04
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-17
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Primary Completion: 2026-05-04
• Study Completion: 2028-05-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TBI + Rehabilitation	Post Acute Rehabiltation	Traumatic Brain Injury patients that received post acute rehabilitation
CVA + Rehabilitation	Post Acute Rehabiltation	Stroke patients that received post acute rehabilitation

Primary Outcome Measures

Name	Time	Method
Effects of rehabilitation on long term occupational Status after injury	1 to 10 years	Occupational Status Questionnaire
Effects of rehabilitation on long term disability function after injury	1 to 10 years	Supervision Rating Scale and Disability Rating Scale
Effects of rehabilitation on long term cognitive function after injury	1 to 10 years	Brief Test of Adult Cognition by Telephone
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

Name	Time	Method
Effects of rehabilitation on long term health after injury	1 to 10 years	TBI and Health in Adults Questionnaire

Trial Locations

Locations (1)

Centre for Neuro Skills; 🇺🇸 Encino, California, United States