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Spatial Cognitive Training for Chronic Vestibular Disorders

Primary Purpose

Vestibular Abnormality, Cognitive Training

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spatial Cognitive Training
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Abnormality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Spatial Cognitive Training

    Arm Description

    map reading and route-learning skills

    Outcomes

    Primary Outcome Measures

    Change from baseline in Dizziness Handicap Inventory
    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
    Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100
    Change from baseline in Dynamic Gait Index
    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
    Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.
    Change from baseline in Four Square Step Test
    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
    Assesses dynamic balance, spatial, & sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)

    Secondary Outcome Measures

    Change from baseline in Money Road Map Test
    Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.
    Change from immediate post-training to 3-months post-training in Money Road Map Test
    Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.
    Change from baseline in Benton Visual Retention Test
    visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.
    Change from immediate post-training to 3-months post-training in Benton Visual Retention Test
    visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.
    Change from baseline in modified Clinical Test of Sensory Organization and Balance
    Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.
    Change from immediate post-training to 3-months post-training in modified Clinical Test of Sensory Organization and Balance
    Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.
    Change from baseline in Activities-specific Balance Confidence Scale
    Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)
    Change from immediate post-training to 3-months post-training in Activities-specific Balance Confidence Scale
    Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)
    Change from baseline in Santa Barbara Sense of Direction Scale
    15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.
    Change from immediate post-training to 3-months post-training in Santa Barbara Sense of Direction Scale
    15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.

    Full Information

    First Posted
    May 11, 2019
    Last Updated
    September 8, 2020
    Sponsor
    University of Pittsburgh
    Collaborators
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03950648
    Brief Title
    Spatial Cognitive Training for Chronic Vestibular Disorders
    Official Title
    Spatial Cognitive Training for Chronic Vestibular Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    COVID-19
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2020 (Anticipated)
    Study Completion Date
    August 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pittsburgh
    Collaborators
    Johns Hopkins University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vestibular Abnormality, Cognitive Training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Spatial Cognitive Training
    Arm Type
    Experimental
    Arm Description
    map reading and route-learning skills
    Intervention Type
    Behavioral
    Intervention Name(s)
    Spatial Cognitive Training
    Intervention Description
    map reading and route-learning skills
    Primary Outcome Measure Information:
    Title
    Change from baseline in Dizziness Handicap Inventory
    Description
    Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100
    Time Frame
    Baseline vs immediately post-training
    Title
    Change from immediate post-training to 3-months post-training in Dizziness Handicap Inventory
    Description
    Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100
    Time Frame
    Immediately post-training to 3 months post-training
    Title
    Change from baseline in Dynamic Gait Index
    Description
    Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.
    Time Frame
    Baseline vs immediately post-training
    Title
    Change from immediate post-training to 3-months post-training in Dynamic Gait Index
    Description
    Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.
    Time Frame
    Immediately post-training to 3 months post-training
    Title
    Change from baseline in Four Square Step Test
    Description
    Assesses dynamic balance, spatial, & sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)
    Time Frame
    Baseline vs immediately post-training
    Title
    Change from immediate post-training to 3-months post-training in Four Square Step Test
    Description
    Assesses dynamic balance, spatial, & sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)
    Time Frame
    Immediately post-training to 3 months post-training
    Secondary Outcome Measure Information:
    Title
    Change from baseline in Money Road Map Test
    Description
    Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.
    Time Frame
    Baseline vs immediately post-training
    Title
    Change from immediate post-training to 3-months post-training in Money Road Map Test
    Description
    Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.
    Time Frame
    Immediately post-training to 3 months post-training
    Title
    Change from baseline in Benton Visual Retention Test
    Description
    visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.
    Time Frame
    Baseline vs immediately post-training
    Title
    Change from immediate post-training to 3-months post-training in Benton Visual Retention Test
    Description
    visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.
    Time Frame
    Immediately post-training to 3 months post-training
    Title
    Change from baseline in modified Clinical Test of Sensory Organization and Balance
    Description
    Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.
    Time Frame
    Baseline vs immediately post-training
    Title
    Change from immediate post-training to 3-months post-training in modified Clinical Test of Sensory Organization and Balance
    Description
    Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.
    Time Frame
    Immediately post-training to 3 months post-training
    Title
    Change from baseline in Activities-specific Balance Confidence Scale
    Description
    Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)
    Time Frame
    Baseline vs immediately post-training
    Title
    Change from immediate post-training to 3-months post-training in Activities-specific Balance Confidence Scale
    Description
    Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)
    Time Frame
    Immediately post-training to 3 months post-training
    Title
    Change from baseline in Santa Barbara Sense of Direction Scale
    Description
    15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.
    Time Frame
    Baseline vs immediately post-training
    Title
    Change from immediate post-training to 3-months post-training in Santa Barbara Sense of Direction Scale
    Description
    15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.
    Time Frame
    Immediately post-training to 3 months post-training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brooke Klatt, PhD, PT
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    dissemination of study findings in manuscript publication in scientific journal
    IPD Sharing Time Frame
    1 year

    Learn more about this trial

    Spatial Cognitive Training for Chronic Vestibular Disorders

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