- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05056324
Web-based Rehab After Acute Vertigo
March 25, 2025 updated by: Umeå University
Internet-based Vestibular Rehabilitation Versus Standard Care After Acute Onset Vertigo
Acute onset vertigo is common and entails much suffering with persisting symptoms at 3 months after onset in up to half of those afflicted.
Vestibular rehabilitation to aid recovery is not readily available.
The purpose of this study is to investigate the effects on vertigo symptoms of a 6-week online vestibular rehabilitation tool compared with standard care (written instructions leaflet) after acute onset vertigo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
184
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
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-
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Borås, Sweden
- Södra Älvsborg Hospital
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Göteborg, Sweden
- Sahlgrenska University Hospital
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Linköping, Sweden
- University Hospital Linköping
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Sollefteå, Sweden
- Sollefteå Hospital
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Stockholm, Sweden
- Karolinska University Hospital
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Stockholm, Sweden
- Capio Sankt Görans Hospital
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Sundsvall, Sweden
- Sundsvall Hospital
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Södra Sunderbyn, Sweden
- Sunderby Hospital
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Umeå, Sweden
- University Hospital Umeå
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ≥18 years old; and
- The subject has given written consent to participate in the study; and
- New acute onset dizziness or vertigo since ≥24 hours with pathological spontaneous or gaze-evoked nystagmus (i.e. an acute vestibular syndrome, AVS). The nystagmus as described above must be present at investigation between 24 hours and 7 days from onset, spontaneously, gaze-evoked or head-shake evoked and documented; and
- Screening and inclusion within 7 days of onset of continuous symptoms; and
- Symptomatic at inclusion
Exclusion Criteria:
- Pre-existing vestibular disease or neurological disease anticipated to affect the ability to participate in the study or the effect of the intervention. N.B: Recurring AVS with no set diagnosis before inclusion is accepted, as is past transient neurological diseases such as TIA or migraine; or
- Inability to use the online rehabilitation tool, e.g. due to not having access to a computer, tablet or smartphone, not having access to the internet or lacking in experience with such tools; or
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation; or
- Medical and/or physical contraindications to making the required head movements (e.g. vertebral dissection) or otherwise participating in the training and testing exercises or data collection; or
- Medication or other substance intake which can affect the ability to participate in the study or the reliability of the measurement methods. These medications include regular use of: Anticonvulsants, antiemetics/motion sickness medications, benzodiazepines, neuroleptics. Transient corticosteroid and/or antiemetic treatment related to the current vertigo is accepted.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
For those randomized to the intervention group, a 6 weeks duration vestibular rehabilitation will be delivered using an online tool (YrselTräning)
|
|
Active Comparator: Control group
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For those randomized to the control group, a 6 weeks duration standard vestibular rehabilitation will be delivered using a written instructions leaflet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The between group mean Vertigo Symptom Scale Short Form (VSS-SF) score difference
Time Frame: 6 weeks after vertigo onset
|
VSS-SF uses a five-point Likert scale: 0 (never), 1 (a few times), 2 (several times), 3 (quite often [every week]), and 4 (very often [most days]).
The score ranges from 0 to 60.
A higher score indicates worse symptoms.
|
6 weeks after vertigo onset
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The between groups mean Dizziness Handicap Inventory (DHI) score
Time Frame: 6 weeks and 3 months after vertigo onset
|
The Dizziness Handicap Inventory (DHI) uses a three-point scale to rate each item: 0 (no), 2 (sometimes), and 4 (always).
The score ranges from 0 to 100.
A higher overall score indicates more severe handicap.
|
6 weeks and 3 months after vertigo onset
|
|
The between groups changes in timed 25-foot walk test (T25-FW)); body sway during standing and walking; and the mobility
Time Frame: From baseline to 6 weeks and 3 months
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From baseline to 6 weeks and 3 months
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|
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The between groups changes in video head impulse test (vHIT, site-dependent)
Time Frame: 6 weeks and 3 months after vertigo onset
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6 weeks and 3 months after vertigo onset
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|
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The between groups changes in video head impulse test (vHIT, site-dependent) measured lateral canal VOR gain and saccades
Time Frame: From baseline to 6 weeks and 3 months
|
From baseline to 6 weeks and 3 months
|
|
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The between groups mean vertigo symptom scale short form (VSS-SF) score
Time Frame: 12 months after vertigo onset
|
VSS-SF uses a five-point Likert scale: 0 (never), 1 (a few times), 2 (several times), 3 (quite often [every week]), and 4 (very often [most days]).
The score ranges from 0 to 60.
A higher score indicates worse symptoms.
|
12 months after vertigo onset
|
|
The between group pedometer-derived mean weekly number of steps walked since last visit
Time Frame: 3 months after vertigo onset
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3 months after vertigo onset
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|
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The between groups mean number of weekly training sessions
Time Frame: 6 weeks after vertigo onset
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6 weeks after vertigo onset
|
|
|
Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave)
Time Frame: 12 months
|
12 months
|
|
|
The difference in kinematic output between measurement systems (i.e., multi-sensor and mobile app)
Time Frame: Three months after symptom onset
|
Three months after symptom onset
|
|
|
The reliability of the Swedish VSS-SF translation
Time Frame: Six weeks after symptom onset
|
Six weeks after symptom onset
|
|
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The frequency of BPPV at 6 weeks and 3 months after AVS onset using a BPPV specific questionnaire and positional nystagmus tests
Time Frame: 6 weeks and 3 months after vertigo onset
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6 weeks and 3 months after vertigo onset
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The proportion of participants who has experienced falls/fractures since study start
Time Frame: 6 weeks, 3 months and 12 months
|
6 weeks, 3 months and 12 months
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The number of falls/fractures in each study arm
Time Frame: 6 weeks, 3 months and 12 months
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6 weeks, 3 months and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonatan Salzer, MD, PhD, Umeå University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Surano S, Faergemann E, Granasen G, Salzer J. The reliability and validity of the Swedish translation of the Vertigo Symptom Scale - short form in a cohort with acute vestibular syndrome. Ann Med. 2025 Dec;57(1):2457517. doi: 10.1080/07853890.2025.2457517. Epub 2025 Feb 10.
- Surano S, Grip H, Ohberg F, Karlsson M, Faergemann E, Bjurman M, Davidsson H, Ledin T, Lindell E, Mathe J, Tjernstrom F, Tomanovic T, Granasen G, Salzer J. Internet-based vestibular rehabilitation versus standard care after acute onset vertigo: a study protocol for a randomized controlled trial. Trials. 2022 Jun 16;23(1):496. doi: 10.1186/s13063-022-06460-0.
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)
October 1, 2021
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
March 12, 2025
Study Registration Dates
First Submitted
September 7, 2021
First Submitted That Met QC Criteria
September 15, 2021
First Posted (Actual)
September 24, 2021
Study Record Updates
Last Update Posted (Actual)
March 30, 2025
Last Update Submitted That Met QC Criteria
March 25, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Web-based vertigo rehab
- CIV-21-05-036744 (Other Identifier: Swedish Medical Products Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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