Traumatic Brain Injury and Stroke Long Term Outcome

July 18, 2022 updated by: Centre for Neuro Skills

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult subjects with a traumatic brain injury or stroke

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TBI + Rehabilitation
Traumatic Brain Injury patients that received post acute rehabilitation
Other: Post Acute Rehabiltation
TBI + No Rehabilitation
Traumatic Brain Injury patients that did not receive post acute rehabilitation
CVA + Rehabilitation
Stroke patients that received post acute rehabilitation
Other: Post Acute Rehabiltation
CVA + No Rehabilitation
Stroke patients that did not received post acute rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of rehabilitation on long term occupational Status after injury
Time Frame: 1 to 10 years
Occupational Status Questionnaire
1 to 10 years
Effects of rehabilitation on long term cognitive function after injury
Time Frame: 1 to 10 years
Brief Test of Adult Cognition by Telephone
1 to 10 years
Effects of rehabilitation on long term disability function after injury
Time Frame: 1 to 10 years
Supervision Rating Scale and Disability Rating Scale
1 to 10 years
Effects of rehabilitation on long term quality of life after injury
Time Frame: 1 to 10 years
Quality of Life in Neurological Disorders Measures (NeuroQOL)
1 to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of rehabilitation on long term health after injury
Time Frame: 1 to 10 years
TBI and Health in Adults Questionnaire
1 to 10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of rehabilitation on post mortem health after injury
Time Frame: 1 to 10 years
Post- Mortem health Assessment
1 to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Neuro Skills

Investigators

  • Principal Investigator: Grace S Griesbach, PhD, Centre for Neuro Skills

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2016

Primary Completion (Anticipated)

May 4, 2026

Study Completion (Anticipated)

May 4, 2028

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 8, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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