DizzinessED-VeRTNCT05122663
Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo
An observational study of Dizziness and Vertigo, run by Northwestern University at 1 site in United States.
Trial summary
ED-VeRT will enroll up to 125 adult emergency department (ED) patients presenting with a chief complaint of dizziness or vertigo to collect longitudinal outcomes over 3 months of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Vestibular Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to 1 May 2023
- Phase
- Observational
- 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
Study population: ED patients presenting with a chief complaint relating to dizziness or vertigo.
Who may be able to join
- Chief complaint relating to dizziness or vertigo
- Ability to complete follow-up data collection electronically or by telephone
- English-speaking
Who cannot join
- Severe neurologic deficit concerning for ischemic or hemorrhagic stroke
- Known pregnancy, under police custody, unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Pilot Feasibility Trial of Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo
ED-VeRT will enroll up to 125 adult emergency department (ED) patients presenting with a chief complaint of dizziness or vertigo to collect longitudinal outcomes over 3 months of follow-up. This will include 50 patients who were evaluated by an ED physical therapist (ie, vestibular rehabilitation) during their ED visit and 50 patients who received usual care. The aims of this trial are to: (1) obtain initial estimates of participant recruitment and retention, intra-cluster correlation, and between-group outcome differences that will inform sample size calculation for a future randomized clinical trial, and (2) assess feasibility and fidelity of a clinical classification protocol for undifferentiated dizziness among patients receiving ED vestibular rehabilitation.
- Being tested
- Vestibular Rehabilitation, Usual Care
- Medical subject headings
- Dizziness, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular RehabilitationBehavioural
Vestibular Rehabilitation refers to the specific interventions that physical therapists provide to patients with dizziness and vertigo symptoms. These interventions can involve repositioning maneuvers, habituation exercises, gaze stabilization, and/or balance training exercises, depending on the specific etiology of dizziness and vertigo per an established clinical protocol utilizing a patient's history and exam findings. Physical therapists instruct patients in how to perform these exercises at home and provide instructions and referral for patients to follow-up with an outpatient physical therapist for further care.
Usual CareOther
Usual Care refers to any combination of diagnostic testing, medications, and patient education or counseling provided by a patient's treating ED physician.
| Study group | Role | What they receive |
|---|---|---|
| ED Physical Therapy | Patients in the ED physical therapy group will have been evaluated by an emergency department physical therapist for dizziness/vertigo during their index ED visit. Receives: Behavioral: Vestibular Rehabilitation | |
| Usual Care | Patients in the usual care group will NOT have received an evaluation by an ED physical therapist for dizziness/vertigo symptoms during their index ED visit. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory (DHI)
The DHI contains 25 items quantifying self-perceived handicapping effects of dizziness symptoms.
Measured: Three months after the index ED visit.
Secondary outcomes (4)
Vestibular Activities Avoidance Instrument (VAAI-9)
The VAAI-9 identifies fear avoidance beliefs in persons with dizziness. The VAAI-9 is the 9-item short form version of the VAAI.
Measured: Three months after the index ED visit.
ED Diagnostic Imaging Utilization
The proportion of ED visits in which any diagnostic imaging of the brain was performed, including computed tomography and magnetic resonance imaging.
Measured: Index ED visit (one day)
ED Length of Stay
Total length of stay, inclusive of hospitalizations and observation stays.
Measured: Index ED visit (up to one week)
Patient-Reported Medication Use in Last 24 Hours
Patient-reported medication use for dizziness will be collected using a standardized instrument assess whether participants have taken any dizziness medication in the last 24 hours (binary yes/no). The 24-hour timeframe was selected to maximize accuracy in patient recall. In brief, dizziness medications are listed by brand and generic names; a "yes" response to any medication triggers an additional query asking the participant to specify the medication dose (e.g., meclizine 25mg) and quantity (e.g., one pill).
Measured: Three months after the index ED visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start16 Nov 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Kim, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122663
- Sponsor's protocol ID
- STU00215925
- Acronym
- ED-VeRT
- Status last verified
- Jul 2024
- First submitted
- 12 Nov 2021
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HS, Schauer JM, Kan AK, Alinger JB, Strickland KJ, Garreau A, McCarthy DM, Taylor ZB, Fishman IL, Muschong KM, Roth HR. Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459567. doi: 10.1001/jamanetworkopen.2024.59567.
PubMed 39951266
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Trial of Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo
- ClinicalTrials.gov ID
- NCT05122663
- Acronym / sponsor ID
- ED-VeRT / STU00215925
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 17 Nov 2021 (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.
ED-VeRT will enroll up to 125 adult emergency department (ED) patients presenting with a chief complaint of dizziness or vertigo to collect longitudinal outcomes over 3 months of follow-up. This will include 50 patients who were evaluated by an ED physical therapist (ie, vestibular rehabilitation) during their ED visit and 50 patients who received usual care. The aims of this trial are to: (1) obtain initial estimates of participant recruitment and retention, intra-cluster correlation, and between-group outcome differences that will inform sample size calculation for a future randomized clinical trial, and (2) assess feasibility and fidelity of a clinical classification protocol for undifferentiated dizziness among patients receiving ED vestibular rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED Physical Therapy | – | Behavioral: Vestibular RehabilitationPatients in the ED physical therapy group will have been evaluated by an emergency department physical therapist for dizziness/vertigo during their index ED visit. |
| Usual Care | – | Other: Usual CarePatients in the usual care group will NOT have received an evaluation by an ED physical therapist for dizziness/vertigo symptoms during their index ED visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ED patients presenting with a chief complaint relating to dizziness or vertigo.
Key inclusion criteria (3 listed)
- Chief complaint relating to dizziness or vertigo
- Ability to complete follow-up data collection electronically or by telephone
- English-speaking
Key exclusion criteria (2 listed)
- Severe neurologic deficit concerning for ischemic or hemorrhagic stroke
- Known pregnancy, under police custody, unable to consent
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 |
|---|---|---|
| Vestibular RehabilitationVestibular Rehabilitation refers to the specific interventions that physical therapists provide to patients with dizziness and vertigo symptoms. These interventions can involve repositioning maneuvers, habituation exercises, gaze stabilization, and/or balance training exercises, depending on the specific etiology of dizziness and vertigo per an established clinical protocol utilizing a patient's history and exam findings. Physical therapists instruct patients in how to perform these exercises at home and provide instructions and referral for patients to follow-up with an outpatient physical therapist for further care. | Behavioural | ED Physical Therapy |
| Usual CareUsual Care refers to any combination of diagnostic testing, medications, and patient education or counseling provided by a patient's treating ED physician. | Other | Usual Care |
Primary outcome
Dizziness Handicap Inventory (DHI)
Time frame: Three months after the index ED visit.
The DHI contains 25 items quantifying self-perceived handicapping effects of dizziness symptoms.
4 secondary outcomes
Vestibular Activities Avoidance Instrument (VAAI-9)
Time frame: Three months after the index ED visit.
ED Diagnostic Imaging Utilization
Time frame: Index ED visit (one day)
ED Length of Stay
Time frame: Index ED visit (up to one week)
Patient-Reported Medication Use in Last 24 Hours
Time frame: Three months after the index ED visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 39951266Kim HS, Schauer JM, Kan AK, Alinger JB, Strickland KJ, Garreau A, McCarthy DM, Taylor ZB, Fishman IL, Muschong KM, Roth HR. Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459567. doi: 10.1001/jamanetworkopen.2024.59567.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dizziness and Vertigo, run by Northwestern University at 1 site in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dizziness Handicap Inventory (DHI) (time frame: Three months after the index ED visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122663, which also lists 1 linked publication.
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 12 Jul 2024.