- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06271694
Activity and Participation in Vestibular Disorders (APV)
March 27, 2026 updated by: Brooke Klatt, University of Pittsburgh
Impairments and Personal Factors Associated With Activity and Participation in Vestibular Rehabilitation
This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy.
Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Adults aged 18-years and older with symptomatic complaints of dizziness and/or imbalance and a medical diagnosis of unilateral vestibular hypofunction will be recruited at the time of their entry into vestibular rehabilitation.
The investigators will analyze what factors (impairments and personal factors) are related to activity and participation in people with vestibular disorders and see if change in activity and participation is related to recovery from vestibulopathy.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15206
- UPMC-Rehab Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18-years and older with symptomatic complaints of dizziness and/or imbalance and a medical diagnosis of unilateral vestibular hypofunction
Exclusion Criteria:
- 1. Cognition <18 on Montreal Cognitive Assessment (MoCA)
- 2. Visual acuity worse than 20/40 with corrected lenses
- 3. Loss of protective distal sensation (defined as the inability to feel a 4.31 size monofilament on the plantar surface of the foot)
- 4. Inability to engage in community mobility
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Standard Vestibular Rehabilitation
All participants will receive standard vestibular rehabilitation
|
Standard vestibular rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Late-life Function and Disability Instrument
Time Frame: 8-weeks
|
Activity and Participation (raw 16-80; scale 0-100 min-max scores); higher is better
|
8-weeks
|
|
Dizziness Handicap Inventory
Time Frame: 8-weeks
|
Dizziness disability; 0-100 (min-max score); higher is greater disability.
|
8-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brooke Klatt, PhD, Assistant Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2024
Primary Completion (Actual)
February 6, 2026
Study Completion (Actual)
February 6, 2026
Study Registration Dates
First Submitted
January 11, 2024
First Submitted That Met QC Criteria
February 20, 2024
First Posted (Actual)
February 22, 2024
Study Record Updates
Last Update Posted (Actual)
March 30, 2026
Last Update Submitted That Met QC Criteria
March 27, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY22020027
- 1K23DC020215-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified participant data that underlie the results reported in the article could be shared with researchers who provide a methodologically sound proposal.
IPD Sharing Time Frame
Immediately following article publication.
No end date.
IPD Sharing Access Criteria
To gain access to data requestors will need to sign a data access agreement and proposals should be directed at klattresearch@pitt.edu
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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