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Spatial Cognitive Training for Chronic Vestibular Disorders

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ClinicalTrials.gov Identifier: NCT03950648
Recruitment Status : Withdrawn (COVID-19)
First Posted : May 15, 2019
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Brooke Klatt, University of Pittsburgh

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).

Condition or disease Intervention/treatment Phase
Vestibular Abnormality Cognitive Training Behavioral: Spatial Cognitive Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spatial Cognitive Training for Chronic Vestibular Disorders
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: Spatial Cognitive Training
map reading and route-learning skills
Behavioral: Spatial Cognitive Training
map reading and route-learning skills




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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)

  6. 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)


Secondary Outcome Measures :
  1. Change from baseline in Money Road Map Test [ Time Frame: Baseline vs immediately post-training ]
    Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.

  2. Change from immediate post-training to 3-months post-training in Money Road Map Test [ Time Frame: Immediately post-training to 3 months post-training ]
    Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.

  3. Change from baseline in Benton Visual Retention Test [ Time Frame: Baseline vs immediately post-training ]
    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.

  4. Change from immediate post-training to 3-months post-training in Benton Visual Retention Test [ Time Frame: Immediately post-training to 3 months post-training ]
    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.

  5. Change from baseline in modified Clinical Test of Sensory Organization and Balance [ Time Frame: Baseline vs immediately post-training ]
    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.

  6. Change from immediate post-training to 3-months post-training in modified Clinical Test of Sensory Organization and Balance [ Time Frame: Immediately post-training to 3 months post-training ]
    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.

  7. Change from baseline in Activities-specific Balance Confidence Scale [ Time Frame: Baseline vs immediately post-training ]
    Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)

  8. Change from immediate post-training to 3-months post-training in Activities-specific Balance Confidence Scale [ Time Frame: Immediately post-training to 3 months post-training ]
    Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)

  9. Change from baseline in Santa Barbara Sense of Direction Scale [ Time Frame: Baseline vs immediately post-training ]
    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.

  10. Change from immediate post-training to 3-months post-training in Santa Barbara Sense of Direction Scale [ Time Frame: Immediately post-training to 3 months post-training ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950648


Sponsors and Collaborators
University of Pittsburgh
Johns Hopkins University
Investigators
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Principal Investigator: Brooke Klatt, PhD, PT University of Pittsburgh
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Responsible Party: Brooke Klatt, Postdoctoral Research Fellow, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03950648    
Other Study ID Numbers: STUDY19030436
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: dissemination of study findings in manuscript publication in scientific journal
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 1 year

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases