Clinical trial NCT03950648: Spatial Cognitive Training for Chronic Vestibular Disorders
Official title: Spatial Cognitive Training for Chronic Vestibular Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vestibular Abnormality
Cognitive Training
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2019-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the investigators propose to apply cognitive training, which has been largely used in the realm of age-related cognitive decline, dementia, and Alzheimer's disease, in a novel clinical context to individuals with vestibular impairment. In prior work the investigators observed that individuals with vestibular loss have evidence of spatial cognitive impairment. The investigators plan to evaluate the preliminary efficacy and feasibility of a cognitive training program in a sample of participants with chronic vestibular impairment who display deficits in spatial ability. The cognitive training program will focus on visuospatial skills and will be used as an adjunct to traditional vestibular physical therapy (VPT).

Detailed description: Patients with chronic vestibular dysfunction with report symptoms of spatial cognitive impairment will be offered cognitive training. The intervention will consist of a well-validated cognitive training protocol that specifically targets spatial navigation skills. The protocol was developed by Willis et al. for the Adult Development and Enrichment Trial (ADEPT) trial, which trains map reading and route-learning skills through mental rotation training tasks over the course of 5 weeks. Patients will be assessed by study staff pre-intervention, immediately post-intervention and at 3 months post-intervention using spatial cognitive outcomes, quality of life measures, and gait and balance outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic vestibular disorder (\>6months \& diagnosis from laboratory testing by neuro-otologist)

Exclusion Criteria:

* Participants with dementia, or with blindness or deafness who cannot participate in cognitive training procedures.

Primary outcomes:
measure: Change from baseline in Dizziness Handicap Inventory
timeFrame: Baseline vs immediately post-training
measure: Change from immediate post-training to 3-months post-training in Dizziness Handicap Inventory
timeFrame: Immediately post-training to 3 months post-training
measure: Change from baseline in Dynamic Gait Index
timeFrame: Baseline vs immediately post-training
measure: Change from immediate post-training to 3-months post-training in Dynamic Gait Index
timeFrame: Immediately post-training to 3 months post-training
measure: Change from baseline in Four Square Step Test
timeFrame: Baseline vs immediately post-training
measure: Change from immediate post-training to 3-months post-training in Four Square Step Test
timeFrame: Immediately post-training to 3 months post-training
Secondary outcomes:
measure: Change from baseline in Money Road Map Test
timeFrame: Baseline vs immediately post-training
measure: Change from immediate post-training to 3-months post-training in Money Road Map Test
timeFrame: Immediately post-training to 3 months post-training
measure: Change from baseline in Benton Visual Retention Test
timeFrame: Baseline vs immediately post-training
measure: Change from immediate post-training to 3-months post-training in Benton Visual Retention Test
timeFrame: Immediately post-training to 3 months post-training
measure: Change from baseline in modified Clinical Test of Sensory Organization and Balance
timeFrame: Baseline vs immediately post-training
measure: Change from immediate post-training to 3-months post-training in modified Clinical Test of Sensory Organization and Balance
timeFrame: Immediately post-training to 3 months post-training
measure: Change from baseline in Activities-specific Balance Confidence Scale
timeFrame: Baseline vs immediately post-training
measure: Change from immediate post-training to 3-months post-training in Activities-specific Balance Confidence Scale
timeFrame: Immediately post-training to 3 months post-training
measure: Change from baseline in Santa Barbara Sense of Direction Scale
timeFrame: Baseline vs immediately post-training
measure: Change from immediate post-training to 3-months post-training in Santa Barbara Sense of Direction Scale
timeFrame: Immediately post-training to 3 months post-training
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Brooke Klatt, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: