Traumatic Brain Injury and Stroke Long Term Outcome

NCT ID: NCT03399929

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-04

Study Completion Date

2028-05-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TBI + Rehabilitation

Traumatic Brain Injury patients that received post acute rehabilitation

Post Acute Rehabiltation

Intervention Type OTHER

TBI + No Rehabilitation

Traumatic Brain Injury patients that did not receive post acute rehabilitation

No interventions assigned to this group

CVA + Rehabilitation

Stroke patients that received post acute rehabilitation

Post Acute Rehabiltation

Intervention Type OTHER

CVA + No Rehabilitation

Stroke patients that did not received post acute rehabilitation

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Post Acute Rehabiltation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre for Neuro Skills

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Grace S Griesbach, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Neuro Skills

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre for Neuro Skills

Encino, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Grace S Griesbach, PhD

Role: CONTACT

(818)783-3800

Stefanie Howell, PhD

Role: CONTACT

(972)580-8500

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Grace S Griesbach, PhD

Role: primary

818-783-3800

Stefanie Howell, PhD

Role: backup

(972)580-8500

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LTO1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognition and Motor Learning Post-stroke
NCT04829071 RECRUITING EARLY_PHASE1