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Withdrawn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
About this trial
This is an interventional treatment trial for Vestibular Abnormality
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.
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
NCT ID
NCT03950648
First Posted
May 11, 2019
Last Updated
September 8, 2020
Sponsor
University of Pittsburgh
Collaborators
Johns Hopkins University
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
We'll reach out to this number within 24 hrs