Determining the Incidence of Vestibular Dysfunction in Traumatic Brain Injury Patients

NCT04592575 | Completed

• 1 other identifier: STU00212535
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Injuries, Traumatic

Keywords

Traumatic Brain Injury; Acute TBI; Vestibular Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Vestibular Evaluation by Physical Therapist

  After screening tool completed and referral by physician to vestibular therapist

Study Arms (2)

TBI that are positive on screening tool

Patients that are identified on the AbilityLab Vestibular screening tool as possibly having vestibular dysfunction

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

Other: Vestibular Evaluation

Interventions

Vestibular Evaluation OTHER

Each patient will have a full vestibular evaluation by a physical therapist

TBI patients not positive on screening tool; TBI that are positive on screening tool

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Traumatic brain injury patients admitted to an inpatient rehabilitation facility

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Holly Paczan, PT

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 19, 2020
• Study Start: December 15, 2020
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)