Brain Injuries, TraumaticNCT04592575
Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients
An observational study of Brain Injuries, Traumatic, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to determine the incidence of vestibular dysfunction in traumatic brain injury patients admitted to acute inpatient rehabilitation. This study also seeks to validate the AbilityLab Vestibular Screening Tool (AVeST) and the AVeST+, tools designed to quickly screen individuals for vestibular… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Vestibular Evaluation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 18 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Traumatic brain injury patients admitted to an inpatient rehabilitation facility
Who may be able to join
- Patients admitted to an inpatient brain injury service at the Shirley Ryan Ability Lab with a history of moderate to severe traumatic brain injury, defined by an initial Glasgow coma scale (GCS) <13 and/or evidence of intracranial injury on neuroimaging
- Able to complete vestibular screening evaluation
- Age >18
- Fluent in English
Who cannot join
- Those with mild traumatic brain injury, defined by an initial Glasgow coma scale (GCS) >13
- Those who are unable to reliably participate in and complete vestibular screening evaluation
- Age <18
- Individuals who do not speak English
- Prior history of vestibular dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients Admitted to Acute Inpatient Rehabilitation
The purpose of this study is to determine the incidence of vestibular dysfunction in traumatic brain injury patients admitted to acute inpatient rehabilitation. This study also seeks to validate the AbilityLab Vestibular Screening Tool (AVeST) and the AVeST+, tools designed to quickly screen individuals for vestibular dysfunction following traumatic brain injury.
Read the detailed description
There are approximately 2.5 million hospital visits in the US each year for traumatic brain injury. Vestibular dysfunction is a common sequela of traumatic brain injury (TBI) affecting up to 50% of TBI patients at 5 years after injury. It is one of the most distressing problems for caregivers following TBI. Further complicating this issue is the fact that many individuals with TBI underestimate the severity of their balance deficits, which may further increase the risk of falls and subsequent injury. Sitting balance on admission to inpatient rehabilitation following TBI has been found to be one of the strongest predictors of functional status at discharge from inpatient rehabilitation. Due to the multifaceted presentation of vestibular dysfunction, evaluation is challenging, and there is currently no standardized approach to screening. While the incidence of vestibular dysfunction has been studied in mild TBI (mTBI) and sports related concussions, there is a gap in the literature regarding the incidence of vestibular dysfunction in moderate to severe TBI patients in acute inpatient rehabilitation.
The benefits of having an established vestibular dysfunction screening and rehabilitation program are multifold. Vestibular rehabilitation following TBI has demonstrated improvements in cognitive function, ability to return to activities of daily living, ability to return to work, and the need for assistance. While one prior single blind randomized controlled trial aimed to evaluate the effectiveness of a structured vestibular rehabilitation program in TBI individuals, there is a need for a large-scale study to evaluate the effectiveness of screening for vestibular dysfunction in order to create a systematic approach. Many TBI patients are not diagnosed with vestibular dysfunction until much later in their hospital course which impedes participation in therapy and likely has a detrimental effect on their rate of recovery. Identifying these patients earlier in their rehabilitation course will allow interventions that will improve and accelerate patient outcomes. An additional benefit of this study is to determine the incidence of vestibular dysfunction in moderate to severe TBI patients to outline the necessary resources to care for patients with this problem. Data collected will be utilized to validate the AVeST and the AVeST+. Additionally, this study will fill a gap in the literature in delineating the incidence of vestibular impairment in individuals with moderate to severe brain injury, a population heretofore not previously studied.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Vestibular Evaluation
- Keywords
- Traumatic Brain Injury, Acute TBI, Vestibular Dysfunction
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular EvaluationOther
Each patient will have a full vestibular evaluation by a physical therapist
| Study group | Role | What they receive |
|---|---|---|
| TBI that are positive on screening tool | Patients that are identified on the AbilityLab Vestibular screening tool as possibly having vestibular dysfunction Receives: Other: Vestibular Evaluation | |
| TBI patients not positive on screening tool | Patients that are not identified on the Ability Lab Vestibular screening tool as possibly having vestibular dysfunction Receives: Other: Vestibular Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AbilityLab Vestibular Screening Tool (AVEST)
a subjective questionnaire (yes/no questions) completed by a physician or therapist
Measured: within the first few days of admission to acute inpatient rehabilitation
AbilityLab Vestibular Screening Tool + (AVEST+)
Physical examination and screen rated as impaired or not impaired
Measured: within the first few days of admission to acute inpatient rehabilitation
Secondary outcomes (1)
Vestibular Evaluation by Physical Therapist
Full oculomotor and vestibular exam to determine vestibular dysfunction
Measured: After screening tool completed and referral by physician to vestibular therapist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Dec 2020
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ripley, Shirley Ryan AbilityLab
- Investigators
- Holly Paczan, PT, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592575
- Sponsor's protocol ID
- STU00212535
- Status last verified
- Dec 2021
- First submitted
- 24 Sep 2020
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients Admitted to Acute Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT04592575
- Acronym / sponsor ID
- STU00212535
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Traumatic Brain Injury, Acute TBI, Vestibular Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 19 Oct 2020 (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.
The purpose of this study is to determine the incidence of vestibular dysfunction in traumatic brain injury patients admitted to acute inpatient rehabilitation. This study also seeks to validate the AbilityLab Vestibular Screening Tool (AVeST) and the AVeST+, tools designed to quickly screen individuals for vestibular dysfunction following traumatic brain injury.
Detailed description
There are approximately 2.5 million hospital visits in the US each year for traumatic brain injury. Vestibular dysfunction is a common sequela of traumatic brain injury (TBI) affecting up to 50% of TBI patients at 5 years after injury. It is one of the most distressing problems for caregivers following TBI. Further complicating this issue is the fact that many individuals with TBI underestimate the severity of their balance deficits, which may further increase the risk of falls and subsequent injury. Sitting balance on admission to inpatient rehabilitation following TBI has been found to be one of the strongest predictors of functional status at discharge from inpatient rehabilitation. Due to the multifaceted presentation of vestibular dysfunction, evaluation is challenging, and there is currently no standardized approach to screening. While the incidence of vestibular dysfunction has been studied in mild TBI (mTBI) and sports related concussions, there is a gap in the literature regarding the incidence of vestibular dysfunction in moderate to severe TBI patients in acute inpatient rehabilitation.
The benefits of having an established vestibular dysfunction screening and rehabilitation program are multifold. Vestibular rehabilitation following TBI has demonstrated improvements in cognitive function, ability to return to activities of daily living, ability to return to work, and the need for assistance. While one prior single blind randomized controlled trial aimed to evaluate the effectiveness of a structured vestibular rehabilitation program in TBI individuals, there is a need for a large-scale study to evaluate the effectiveness of screening for vestibular dysfunction in order to create a systematic approach. Many TBI patients are not diagnosed with vestibular dysfunction until much later in their hospital course which impedes participation in therapy and likely has a detrimental effect on their rate of recovery. Identifying these patients earlier in their rehabilitation course will allow interventions that will improve and accelerate patient outcomes. An additional benefit of this study is to determine the incidence of vestibular dysfunction in moderate to severe TBI patients to outline the necessary resources to care for patients with this problem. Data collected will be utilized to validate the AVeST and the AVeST+. Additionally, this study will fill a gap in the literature in delineating the incidence of vestibular impairment in individuals with moderate to severe brain injury, a population heretofore not previously studied.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI that are positive on screening tool | – | Other: Vestibular EvaluationPatients that are identified on the AbilityLab Vestibular screening tool as possibly having vestibular dysfunction |
| TBI patients not positive on screening tool | – | Other: Vestibular EvaluationPatients that are not identified on the Ability Lab Vestibular screening tool as possibly having vestibular dysfunction |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Traumatic brain injury patients admitted to an inpatient rehabilitation facility
Key inclusion criteria (4 listed)
- Patients admitted to an inpatient brain injury service at the Shirley Ryan Ability Lab with a history of moderate to severe traumatic brain injury, defined by an initial Glasgow coma scale (GCS) <13 and/or evidence of intracranial injury on neuroimaging
- Able to complete vestibular screening evaluation
- Age >18
- Fluent in English
Key exclusion criteria (5 listed)
- Those with mild traumatic brain injury, defined by an initial Glasgow coma scale (GCS) >13
- Those who are unable to reliably participate in and complete vestibular screening evaluation
- Age <18
- Individuals who do not speak English
- Prior history of vestibular dysfunction
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 |
|---|---|---|
| Vestibular EvaluationEach patient will have a full vestibular evaluation by a physical therapist | Other | TBI patients not positive on screening tool, TBI that are positive on screening tool |
Primary outcome
AbilityLab Vestibular Screening Tool (AVEST)
Time frame: within the first few days of admission to acute inpatient rehabilitation
a subjective questionnaire (yes/no questions) completed by a physician or therapist
AbilityLab Vestibular Screening Tool + (AVEST+)
Time frame: within the first few days of admission to acute inpatient rehabilitation
Physical examination and screen rated as impaired or not impaired
1 secondary outcome
Vestibular Evaluation by Physical Therapist
Time frame: After screening tool completed and referral by physician to vestibular therapist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Holly Paczan, PT principal investigator
Shirley Ryan AbilityLab
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 Brain Injuries, Traumatic, run by Shirley Ryan AbilityLab 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 21 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AbilityLab Vestibular Screening Tool (AVEST) (time frame: within the first few days of admission to acute inpatient rehabilitation). The study lists 2 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 21 Dec 2021.