Traumatic Brain Injury and Stroke Long Term Outcome

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03399929
• Other study ID #: LTO1
• Status: Recruiting
• Start date: May 4, 2016
• Est. completion date: May 4, 2028

Study information

• Verified date: July 2022
• Source: Centre for Neuro Skills
• Contact: Grace S Griesbach, PhD
• Phone: (818)783-3800
• Email: researchcentre[@]neuroskills.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 4, 2028
• Est. primary completion date: May 4, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Post Acute Rehabiltation

Locations

Country	Name	City	State
United States	Centre for Neuro Skills	Encino	California

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Neuro Skills

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effects of rehabilitation on post mortem health after injury	Post- Mortem health Assessment	1 to 10 years
Primary	Effects of rehabilitation on long term occupational Status after injury	Occupational Status Questionnaire	1 to 10 years
Primary	Effects of rehabilitation on long term cognitive function after injury	Brief Test of Adult Cognition by Telephone	1 to 10 years
Primary	Effects of rehabilitation on long term disability function after injury	Supervision Rating Scale and Disability Rating Scale	1 to 10 years
Primary	Effects of rehabilitation on long term quality of life after injury	Quality of Life in Neurological Disorders Measures (NeuroQOL)	1 to 10 years
Secondary	Effects of rehabilitation on long term health after injury	TBI and Health in Adults Questionnaire	1 to 10 years