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Clinical Trials/NCT03950648
NCT03950648
Withdrawn
Not Applicable

Spatial Cognitive Training for Chronic Vestibular Disorders

University of Pittsburgh0 sitesJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Spatial Cognitive Training
Conditions
Vestibular Abnormality
Sponsor
University of Pittsburgh
Primary Endpoint
Change from baseline in Dizziness Handicap Inventory
Status
Withdrawn
Last Updated
8 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
April 22, 2026
Last Updated
8 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brooke Klatt

Postdoctoral Research Fellow

University of Pittsburgh

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.

Arms & Interventions

Spatial Cognitive Training

map reading and route-learning skills

Intervention: Spatial Cognitive Training

Outcomes

Primary Outcomes

Change from baseline in Dizziness Handicap Inventory

Time Frame: Baseline vs immediately post-training

Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100

Change from immediate post-training to 3-months post-training in Dizziness Handicap Inventory

Time Frame: Immediately post-training to 3 months post-training

Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100

Change from baseline in Four Square Step Test

Time Frame: Baseline vs immediately post-training

Assesses dynamic balance, spatial, \& sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)

Change from immediate post-training to 3-months post-training in Four Square Step Test

Time Frame: Immediately post-training to 3 months post-training

Assesses dynamic balance, spatial, \& sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)

Change from baseline in Dynamic Gait Index

Time Frame: Baseline vs immediately post-training

Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.

Change from immediate post-training to 3-months post-training in Dynamic Gait Index

Time Frame: Immediately post-training to 3 months post-training

Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.

Secondary Outcomes

  • Change from baseline in Money Road Map Test(Baseline vs immediately post-training)
  • Change from baseline in Santa Barbara Sense of Direction Scale(Baseline vs immediately post-training)
  • Change from immediate post-training to 3-months post-training in Santa Barbara Sense of Direction Scale(Immediately post-training to 3 months post-training)
  • Change from immediate post-training to 3-months post-training in Money Road Map Test(Immediately post-training to 3 months post-training)
  • Change from baseline in Benton Visual Retention Test(Baseline vs immediately post-training)
  • Change from baseline in modified Clinical Test of Sensory Organization and Balance(Baseline vs immediately post-training)
  • Change from baseline in Activities-specific Balance Confidence Scale(Baseline vs immediately post-training)
  • Change from immediate post-training to 3-months post-training in Activities-specific Balance Confidence Scale(Immediately post-training to 3 months post-training)
  • Change from immediate post-training to 3-months post-training in modified Clinical Test of Sensory Organization and Balance(Immediately post-training to 3 months post-training)
  • Change from immediate post-training to 3-months post-training in Benton Visual Retention Test(Immediately post-training to 3 months post-training)

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