- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04592575
Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients
Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients Admitted to Acute Inpatient Rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Shirley Ryan AbilityLab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TBI that are positive on screening tool
Patients that are identified on the AbilityLab Vestibular screening tool as possibly having vestibular dysfunction
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Each patient will have a full vestibular evaluation by a physical therapist
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TBI patients not positive on screening tool
Patients that are not identified on the Ability Lab Vestibular screening tool as possibly having vestibular dysfunction
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Each patient will have a full vestibular evaluation by a physical therapist
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AbilityLab Vestibular Screening Tool (AVEST)
Time Frame: within the first few days of admission to acute inpatient rehabilitation
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a subjective questionnaire (yes/no questions) completed by a physician or therapist
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within the first few days of admission to acute inpatient rehabilitation
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AbilityLab Vestibular Screening Tool + (AVEST+)
Time Frame: within the first few days of admission to acute inpatient rehabilitation
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Physical examination and screen rated as impaired or not impaired
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within the first few days of admission to acute inpatient rehabilitation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vestibular Evaluation by Physical Therapist
Time Frame: After screening tool completed and referral by physician to vestibular therapist
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Full oculomotor and vestibular exam to determine vestibular dysfunction
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After screening tool completed and referral by physician to vestibular therapist
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Holly Paczan, PT, Shirley Ryan AbilityLab
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00212535
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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