Vestibular AbnormalityNCT03950648
Spatial Cognitive Training for Chronic Vestibular Disorders
A study testing Spatial Cognitive Training in people with Vestibular Abnormality and Cognitive Training, run by University of Pittsburgh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Abnormality, Cognitive Training
- What is being tested?
- Spatial Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic vestibular disorder (>6months \& diagnosis from laboratory testing by neuro-otologist)
Who cannot join
- Participants with dementia, or with blindness or deafness who cannot participate in cognitive training procedures.
About this study
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).
Read the 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.
- Conditions
- Vestibular Abnormality, Cognitive Training
- Being tested
- Spatial Cognitive Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial Cognitive TrainingBehavioural
map reading and route-learning skills
| Study group | Role | What they receive |
|---|---|---|
| Spatial Cognitive Training | Experimental | map reading and route-learning skills Receives: Behavioral: Spatial Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Dizziness Handicap Inventory
Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100
Measured: Baseline vs immediately post-training
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
Measured: Immediately post-training to 3 months post-training
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.
Measured: Baseline vs immediately post-training
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.
Measured: Immediately post-training to 3 months post-training
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)
Measured: Baseline vs immediately post-training
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)
Measured: Immediately post-training to 3 months post-training
Secondary outcomes (10)
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.
Measured: Baseline vs immediately post-training
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.
Measured: Immediately post-training to 3 months post-training
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.
Measured: Baseline vs immediately post-training
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.
Measured: Immediately post-training to 3 months post-training
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.
Measured: Baseline vs immediately post-training
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.
Measured: Immediately post-training to 3 months post-training
Change from baseline in Activities-specific Balance Confidence Scale
Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)
Measured: Baseline vs immediately post-training
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%)
Measured: Immediately post-training to 3 months post-training
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.
Measured: Baseline vs immediately post-training
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.
Measured: Immediately post-training to 3 months post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jun 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion22 Apr 2026
Why it stopped: covid-19 and other priorities have emerged
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular AbnormalityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Brooke Klatt, University of Pittsburgh
- Investigators
- Brooke Klatt, PhD, PT, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950648
- Sponsor's protocol ID
- STUDY19030436
- Status last verified
- Apr 2026
- First submitted
- 11 May 2019
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: dissemination of study findings in manuscript publication in scientific journal
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Cognitive Training for Chronic Vestibular Disorders
- ClinicalTrials.gov ID
- NCT03950648
- Acronym / sponsor ID
- STUDY19030436
- Conditions
- Vestibular Abnormality, Cognitive Training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: covid-19 and other priorities have emerged
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spatial Cognitive Training | Experimental | Behavioral: Spatial Cognitive Trainingmap reading and route-learning skills |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of chronic vestibular disorder (>6months \& diagnosis from laboratory testing by neuro-otologist)
Key exclusion criteria (1 listed)
- Participants with dementia, or with blindness or deafness who cannot participate in cognitive training procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatial Cognitive Trainingmap reading and route-learning skills | Behavioural | Spatial Cognitive Training |
Primary outcome
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)
10 secondary outcomes
Change from baseline in Money Road Map Test
Time frame: Baseline vs immediately post-training
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
Change from baseline in Benton Visual Retention Test
Time frame: Baseline vs immediately post-training
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
Change from baseline in modified Clinical Test of Sensory Organization and Balance
Time frame: Baseline vs immediately post-training
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
Change from baseline in Activities-specific Balance Confidence Scale
Time frame: Baseline vs immediately post-training
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
Change from baseline in Santa Barbara Sense of Direction Scale
Time frame: Baseline vs immediately post-training
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. dissemination of study findings in manuscript publication in scientific journal
Related trials for Vestibular Abnormality
Recruiting
A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration
Vestibulopathy, Moderate to Severe Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooke Klatt, PhD, PT principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing Spatial Cognitive Training in people with Vestibular Abnormality and Cognitive Training, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Dizziness Handicap Inventory (time frame: Baseline vs immediately post-training). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.