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出境医 / 临床实验 / Spatial Cognitive Training for Chronic Vestibular Disorders

Spatial Cognitive Training for Chronic Vestibular Disorders

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).

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.
Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: Spatial Cognitive Training
map reading and route-learning skills
 Behavioral: Spatial Cognitive Training
map reading and route-learning skills
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Sponsors and Collaborators
University of Pittsburgh
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Brooke Klatt, PhD, PT University of Pittsburgh
Tracking Information
First Submitted Date  ICMJE May 11, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date September 10, 2020
Estimated Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2019)
  • 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 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.
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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%)
  • 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%)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spatial Cognitive Training for Chronic Vestibular Disorders
Official Title  ICMJE Spatial Cognitive Training for Chronic Vestibular Disorders
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vestibular Abnormality
  • Cognitive Training
Intervention  ICMJE Behavioral: Spatial Cognitive Training
map reading and route-learning skills
Study Arms  ICMJE Experimental: Spatial Cognitive Training
map reading and route-learning skills
Intervention: Behavioral: Spatial Cognitive Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 8, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2019) 		25
Estimated Study Completion Date  ICMJE August 31, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03950648
Other Study ID Numbers  ICMJE STUDY19030436
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: dissemination of study findings in manuscript publication in scientific journal
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 1 year
Responsible Party Brooke Klatt, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Brooke Klatt, PhD, PT University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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