Improving Psychological and Vestibular Health: MINDGAPS
ConditionVestibular Hypofunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Montana
About this trial
The purpose of this study is twofold: 1) Develop norms for measures of inner ear function and psychological health, and 2) Examine the feasibility of using the MINDGAPS system (a remote monitoring system) to track progress during physical therapy or rehabilitation for inner ear problems following a concussion or mild Traumatic Brain Injury.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Veteran or Active Duty Military Service Member
Ability to stand independently
Legally autonomous and able to self-consent
Disqualifiers
Acute head injury (within the previous 2 months)
History of moderate or severe head injury (i.e., loss of consciousness greater than 30 minutes or post-traumatic amnesia greater than 1 day)
Current diagnosis of spine disorders in the neck
Diagnosis of problems with the arteries in your neck
Trial design
Design model
Parallel
Treatments tested in this trial
Rehab
Other intervention6 weeks of vestibular rehabilitation guided by the MINDGAPS decision support system
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: RehabExperimental treatment 1 intervention
Group B: ObservationalNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Computerized Dynamic Visual Acuity (cDVA)
computerized measure of functional gaze stability
Time frame
through study completion, an average of 12 weeksSecondary outcomes
1
Instrumented postural sway assessment
instrumented assessment of static postural stability
Time frame
through study completion, an average of 12 weeks2
Video head impulse testing (vHIT)
computerized assessment of vestibulo-ocular reflex function
Time frame
through study completion, an average of 12 weeks3
Functional Gait Assessment (FGA)
The Functional Gait Assessment (FGA) is a 10-item measure that examines dynamic stability during various walking tasks on a marked 6-m (20-ft) length and 12-inch wide walkway. Each item is rated from 0-3 with higher scores indicating better dynamic stability. Tasks within the FGA require head and/or body motion during walking activities which will be assessed using body-worn 3D inertial measurement units
Time frame
through study completion, an average of 12 weeks4
Dizziness Handicap Inventory (DHI)
The DHI is a self assessment inventory designed to evaluate the self-perceived handicap effects imposed by dizziness or unsteadiness and has documented test-retest and internal consistency reliability. The DHI consists of 25 questions subgroup into functional, emotional, and physical components. The total score ranges from 0-100, with higher scores indicating greater handicap.
Time frame
through study completion, an average of 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Montana
Lead sponsor
United States Naval Medical Center, San Diego
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov