Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients

December 20, 2021 updated by: David Ripley, Shirley Ryan AbilityLab

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

100

Contacts and Locations

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

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Shirley Ryan AbilityLab

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 to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Traumatic brain injury patients admitted to an inpatient rehabilitation facility

Description

Inclusion Criteria:

  1. 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
  2. Able to complete vestibular screening evaluation
  3. Age >18
  4. Fluent in English

Exclusion Criteria:

  1. Those with mild traumatic brain injury, defined by an initial Glasgow coma scale (GCS) >13
  2. Those who are unable to reliably participate in and complete vestibular screening evaluation
  3. Age <18
  4. Individuals who do not speak English
  5. Prior history of vestibular dysfunction

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

  • 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
Each patient will have a full vestibular evaluation by a physical therapist
TBI patients not positive on screening tool
Patients that are not identified on the Ability Lab Vestibular screening tool as possibly having vestibular dysfunction
Each patient will have a full vestibular evaluation by a physical therapist

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
a subjective questionnaire (yes/no questions) completed by a physician or therapist
within the first few days of admission to acute inpatient rehabilitation
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
within the first few days of admission to acute inpatient rehabilitation

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
Full oculomotor and vestibular exam to determine vestibular dysfunction
After screening tool completed and referral by physician to vestibular therapist

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Holly Paczan, PT, Shirley Ryan AbilityLab

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)

December 15, 2020

Primary Completion (Actual)

December 18, 2021

Study Completion (Actual)

December 18, 2021

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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