Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients

Brain Injuries, Traumatic Clinical Trial

Official title:

Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients Admitted to Acute Inpatient Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592575
• Other study ID #: STU00212535
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: December 18, 2021

Study information

• Verified date: December 2021
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 dysfunction following traumatic brain injury.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 18, 2021
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Other:
• Vestibular Evaluation
Each patient will have a full vestibular evaluation by a physical therapist

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AbilityLab Vestibular Screening Tool (AVEST)	a subjective questionnaire (yes/no questions) completed by a physician or therapist	within the first few days of admission to acute inpatient rehabilitation
Primary	AbilityLab Vestibular Screening Tool + (AVEST+)	Physical examination and screen rated as impaired or not impaired	within the first few days of admission to acute inpatient rehabilitation
Secondary	Vestibular Evaluation by Physical Therapist	Full oculomotor and vestibular exam to determine vestibular dysfunction	After screening tool completed and referral by physician to vestibular therapist