Making INformed Decisions in Gaze and Postural Stability: A Pilot Feasibility Study

NCT05391932 | Recruiting

• 2 other identifiers: IRB #10-22R21DC020251
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Hypofunction

Keywords

Rehabilitation; dynamic visual acuity; gaze stability; postural stability; dizziness

Outcome Measures

Primary Outcomes (1)

• Computerized Dynamic Visual Acuity (cDVA)

  computerized measure of functional gaze stability

  through study completion, an average of 12 weeks

Secondary Outcomes (6)

• Instrumented postural sway assessment

  through study completion, an average of 12 weeks

• Video head impulse testing (vHIT)

  through study completion, an average of 12 weeks

• Functional Gait Assessment (FGA)

  through study completion, an average of 12 weeks

• Activities-specific Balance Confidence Scale (ABC)

  through study completion, an average of 12 weeks

• Dizziness Handicap Inventory (DHI)

  through study completion, an average of 12 weeks

Other Outcomes (9)

• Two minute walk test (2MWT)

  through study completion, an average of 12 weeks

• Community Ambulatory Task (CAT)

  through study completion, an average of 12 weeks

• Life Space Mobility Assessment (LSA)

  through study completion, an average of 12 weeks

Interventions

MINDGAPS BEHAVIORAL

Utilize 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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Montana: lead
• Johns Hopkins University: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

RECRUITING

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Brian J Loyd, PhD

CONTACT

406-243-4015; Brian.loyd@umontana.edu

Andy Kittelson, PhD

CONTACT

406-243-4015; Andy.kittelson@umontana.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-cohort double-baseline design

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 26, 2022
• Study Start: May 11, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)