NCT06271694

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

January 11, 2024

Last Update Submit

March 27, 2026

Conditions

Keywords

Vestibular RehabilitationActivity and Participation

Outcome Measures

Primary Outcomes (2)

  • Late-life Function and Disability Instrument

    Activity and Participation (raw 16-80; scale 0-100 min-max scores); higher is better

    8-weeks

  • Dizziness Handicap Inventory

    Dizziness disability; 0-100 (min-max score); higher is greater disability.

    8-weeks

Study Arms (1)

Standard Vestibular Rehabilitation

OTHER

All participants will receive standard vestibular rehabilitation

Other: Vestibular Rehabilitation

Interventions

Standard vestibular rehabilitation

Standard Vestibular Rehabilitation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 18-years and older with symptomatic complaints of dizziness and/or imbalance and a medical diagnosis of unilateral vestibular hypofunction

You may not qualify if:

  • \. Cognition \<18 on Montreal Cognitive Assessment (MoCA)
  • \. Visual acuity worse than 20/40 with corrected lenses
  • \. Loss of protective distal sensation (defined as the inability to feel a 4.31 size monofilament on the plantar surface of the foot)
  • \. Inability to engage in community mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC-Rehab Institute

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Vestibular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesBehavior

Study Officials

  • Brooke Klatt, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2024

First Posted

February 22, 2024

Study Start

January 12, 2024

Primary Completion

February 6, 2026

Study Completion

February 6, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified participant data that underlie the results reported in the article could be shared with researchers who provide a methodologically sound proposal.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Immediately following article publication. No end date.
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

Locations