Making INformed Decisions in Gaze and Postural Stability: A Pilot Feasibility Study
ConditionVestibular Hypofunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Montana
About this trial
The proposed research is relevant to vestibular science and the general public because age-related vestibular hypofunction is a major contributor to poor balance, falls, and other adverse health outcomes. In this investigation the investigators will: 1) assess the preliminary efficacy of a novel intervention system for improving vestibular function and dizziness in community-dwelling older adults, 2) assess the safety and feasibility of the this system, and 3) assess the acceptability and implementation potential of this system, prior to a large-scale, R01-level investigation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Reports issues with dizziness or imbalance
Ability to stand independently
Presence of peripheral vestibular hypofunction as indicated by examination with video nystagmography, video head impulse testing, or dynamic visual acuity testing.
Disqualifiers
cervical spine disorders
vertebral or carotid artery dissection
blindness
peripheral or central oculomotor palsy
Trial design
Design model
Single group
Treatments tested in this trial
MINDGAPS
BehavioralUtilize wearable sensor technology to provide simple, precise measures of gaze and postural stability, as well as remote monitoring of patient adherence to vestibular exercises during a 6-week training period. Additionally, NIH Toolbox data will be used to display patient status compared to normative values and to indicate progress over time relative to measurement error.
Treatment groups
No treatment groups listed
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
Activities-specific Balance Confidence Scale (ABC)
The Activity Specific Balance Confidence Scale (ABC) is a 16-item self-reported measure of balance confidence in performing various activities of daily living. Each question requires an individual to grade his or her self on a scale of 0 to 100 percent for their level of confidence and higher scores indicate greater balance confidence in performing these activities.
Time frame
through study completion, an average of 12 weeksOther outcomes
1
Two minute walk test (2MWT)
Maximal distance walked along a 50 foot course in two minutes. During the test head and/or body motion will be assessed using body-worn 3D inertial measurement units.
Time frame
through study completion, an average of 12 weeks2
Community Ambulatory Task (CAT)
Walking task that simulates community ambulation. During the task 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 weeks3
Life Space Mobility Assessment (LSA)
patient reported questionnaire examining community mobility. The maximum possible score is 40 with higher scores indicating better life space mobility.
Time frame
through study completion, an average of 12 weeks4
Role Participation Questionnaire
patient reported questionnaire assessing participant role in society. The questionnaire asks 17 questions with lower scores indicating greater societal role.
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
Johns Hopkins University
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov