Traumatic Brain InjuryNCT03399929
Traumatic Brain Injury and Stroke Long Term Outcome
An observational study of Traumatic Brain Injury and Stroke, run by Centre for Neuro Skills at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Stroke
- What is being tested?
- Post Acute Rehabiltation
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2016to 4 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with a traumatic brain injury or stroke
Who may be able to join
- Endured a traumatic brain injury or stroke
- Subject or caretaker should be Fluent in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Centre for Neuro Skills
Encino, California, 91436
Grace S Griesbach, PhD, 818-783-3800, researchcentre@neuroskills.com
Stefanie Howell, PhD, (972)580-8500, showell@neuroskills.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Stroke
- Being tested
- Post Acute Rehabiltation
- Keywords
- Rehabilitation, Long term outcome
- Medical subject headings
- Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Acute RehabiltationOther
| Study group | Role | What they receive |
|---|---|---|
| TBI + Rehabilitation | Traumatic Brain Injury patients that received post acute rehabilitation Receives: 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 Receives: Other: Post Acute Rehabiltation | |
| CVA + No Rehabilitation | Stroke patients that did not received post acute rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of rehabilitation on long term occupational Status after injury
Occupational Status Questionnaire
Measured: 1 to 10 years
Effects of rehabilitation on long term cognitive function after injury
Brief Test of Adult Cognition by Telephone
Measured: 1 to 10 years
Effects of rehabilitation on long term disability function after injury
Supervision Rating Scale and Disability Rating Scale
Measured: 1 to 10 years
Effects of rehabilitation on long term quality of life after injury
Quality of Life in Neurological Disorders Measures (NeuroQOL)
Measured: 1 to 10 years
Secondary outcomes (1)
Effects of rehabilitation on long term health after injury
TBI and Health in Adults Questionnaire
Measured: 1 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start4 May 2016
- Primary completion4 May 2026 (estimated)
- Study completion4 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Neuro Skills
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grace S Griesbach, PhD, Principal investigator, Centre for Neuro Skills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399929
- Sponsor's protocol ID
- LTO1
- Status last verified
- Jul 2022
- First submitted
- 8 Jan 2018
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rehabilitation Following Traumatic Brain Injury and Stroke: A Long Term Outcome Study.
- ClinicalTrials.gov ID
- NCT03399929
- Acronym / sponsor ID
- LTO1
- Conditions
- Traumatic Brain Injury, Stroke
- Keywords
- Rehabilitation, Long term outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Centre for Neuro SkillsIndustry (pharma, biotech, devices)
- Study start
- 4 May 2016 (actual)
- Primary completion
- 4 May 2026 (estimated)
- Study completion
- 4 May 2028 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TBI + Rehabilitation | – | Other: Post Acute RehabiltationTraumatic Brain Injury patients that received post acute rehabilitation |
| TBI + No Rehabilitation | – | –Traumatic Brain Injury patients that did not receive post acute rehabilitation |
| CVA + Rehabilitation | – | Other: Post Acute RehabiltationStroke patients that received post acute rehabilitation |
| CVA + No Rehabilitation | – | –Stroke patients that did not received post acute rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with a traumatic brain injury or stroke
Key inclusion criteria (2 listed)
- Endured a traumatic brain injury or stroke
- Subject or caretaker should be Fluent in English
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post Acute Rehabiltation | Other | CVA + Rehabilitation, TBI + Rehabilitation |
Primary outcome
Effects of rehabilitation on long term occupational Status after injury
Time frame: 1 to 10 years
Occupational Status Questionnaire
Effects of rehabilitation on long term cognitive function after injury
Time frame: 1 to 10 years
Brief Test of Adult Cognition by Telephone
Effects of rehabilitation on long term disability function after injury
Time frame: 1 to 10 years
Supervision Rating Scale and Disability Rating Scale
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 secondary outcome
Effects of rehabilitation on long term health after injury
Time frame: 1 to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grace S Griesbach, PhD principal investigator
Centre for Neuro Skills
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Stroke, run by Centre for Neuro Skills at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace S Griesbach, PhD ((818)783-3800, researchcentre@neuroskills.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of rehabilitation on long term occupational Status after injury (time frame: 1 to 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.