Clinical trial NCT05391932: Making INformed Decisions in Gaze and Postural Stability: A Pilot Feasibility Study
Official title: Making INformed Decisions in Gaze and Postural Stability (MINDGAPS): A Novel System for Improving Personalized Care and Patient Adherence in Vestibular Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Hypofunction
Keywords: Rehabilitation
dynamic visual acuity
gaze stability
postural stability
dizziness
Lead sponsor: University of Montana
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-05-26
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-cohort double-baseline design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Deficits in gaze and postural stability are closely linked with vestibular hypofunction. These deficits result in dizziness and poor balance, increasing the risk for falls and other poor health outcomes. Vestibular hypofunction occurs with several conditions and is increasingly prevalent with advancing age. An estimated 85% of people over the age of 80 experience vestibular hypofunction. As with many age-related health challenges (e.g. sarcopenia, osteoporosis, cardiovascular disease), exercise is widely recommended to remediate the effects of vestibular hypofunction. Vestibular rehabilitation has demonstrated efficacy at improving vestibular hypofunction in tightly controlled clinical trials, but the effectiveness in practice is limited by two major barriers: 1) reduced patient adherence to the exercise program, and 2) inability to precisely assess vestibular function. These are overlapping challenges; lack of access to vestibular function assessments impedes effective dosing of rehabilitation as well as monitoring of patient adherence and progress. Thus, personalization and monitoring-essential ingredients of nearly any health or exercise regimen-are functionally missing in vestibular rehabilitation practice.

For this proposal, the investigators have developed the Making INformed Decisions in Gaze and Postural Stability (MINDGAPS) system, which utilizes wearable sensor technology to provide simple, precise measures of gaze and postural stability, as well as remote monitoring of patient adherence to vestibular exercises. Additionally, MINDGAPS leverages NIH Toolbox data to display patient status compared to normative values and to indicate progress over time relative to measurement error. This enables the application of two innovative behavioral science principles aimed at facilitating patient adherence: 1) social norming; comparison of a patient to her or his peers, and 2) frequent monitoring of progress and outcomes. This study is designed to examine the preliminary efficacy of the MINDGAPS system, along with the feasibility, safety, and acceptability of its use in practice. This study will use a single cohort, double-baseline design (n=30 older adults with vestibular hypofunction). Following, the baseline (control) phase, all participants will complete 6 weeks of individualized vestibular rehabilitation informed by the MINDGAPS system. Preliminary efficacy of the intervention will be examined by comparing computerized Dynamic Visual Acuity (cDVA) scores during the intervention phase to cDVA scores during the baseline phase. Feasibility and safety of the intervention will be examined relative to a priori thresholds for recruitment, retention and adherence rates, as well as recording of adverse events. Finally, the acceptability and remote/telehealth capability of the system will be explored using a mixed methods analysis, which will inform system refinement in preparation for a future R01 submission (phase II clinical trial).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* cervical spine disorders
* vertebral or carotid artery dissection
* blindness
* peripheral or central oculomotor palsy
* centrally mediated vestibular dysfunction

Primary outcomes:
measure: Computerized Dynamic Visual Acuity (cDVA)
timeFrame: through study completion, an average of 12 weeks
Secondary outcomes:
measure: Instrumented postural sway assessment
timeFrame: through study completion, an average of 12 weeks
measure: Video head impulse testing (vHIT)
timeFrame: through study completion, an average of 12 weeks
measure: Functional Gait Assessment (FGA)
timeFrame: through study completion, an average of 12 weeks
measure: Activities-specific Balance Confidence Scale (ABC)
timeFrame: through study completion, an average of 12 weeks
measure: Dizziness Handicap Inventory (DHI)
timeFrame: through study completion, an average of 12 weeks
measure: Mini- Balance Evaluation Systems Test (BESTest)
timeFrame: through study completion, an average of 12 weeks
Other outcomes:
measure: Two minute walk test (2MWT)
timeFrame: through study completion, an average of 12 weeks
measure: Community Ambulatory Task (CAT)
timeFrame: through study completion, an average of 12 weeks
measure: Life Space Mobility Assessment (LSA)
timeFrame: through study completion, an average of 12 weeks
measure: Role Participation Questionnaire
timeFrame: through study completion, an average of 12 weeks
measure: General Well Being Scale
timeFrame: through study completion, an average of 12 weeks
measure: Visual Analog Scale of Dizziness and Unsteadiness
timeFrame: through study completion, an average of 12 weeks
measure: Physical Activity Tracker
timeFrame: through study completion, an average of 12 weeks
measure: National Aeronautics and Space Administration (NASA) task load index
timeFrame: through study completion, an average of 12 weeks
measure: System Usability Scale
timeFrame: through study completion, an average of 12 weeks
Locations:
city: Missoula
country: United States
facility: University of Montana
state: Montana
Study officials:
References: