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Acute Vestibular SyndromeNCT05056324

Web-based Rehab After Acute Vertigo

A study testing Online vestibular rehabilitation tool in people with Acute Vestibular Syndrome, run by Umeå University at 9 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Vestibular Syndrome
What is being tested?
Online vestibular rehabilitation tool
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
9 sitesSweden
Study dates
1 Oct 2021to 12 Mar 2025
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

  • ≥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

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Sweden9 sites

  • Södra Älvsborg Hospital

    Borås

  • Sahlgrenska University Hospital

    Gothenburg

  • University Hospital Linköping

    Linköping

  • Sunderby Hospital

    Södra Sunderbyn

  • Sollefteå Hospital

    Sollefteå

  • Capio Sankt Görans Hospital

    Stockholm

  • Karolinska University Hospital

    Stockholm

  • Sundsvall Hospital

    Sundsvall

  • University Hospital Umeå

    Umeå

Other trials in Sweden

About this study

Official title: 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.

Being tested
Online vestibular rehabilitation tool, Standard care (written instructions leaflet)
Keywords
acute vestibular syndrome, vertigo, vestibular rehabilitation
Medical subject headings
Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online vestibular rehabilitation toolDevice

    For those randomized to the intervention group, a 6 weeks duration vestibular rehabilitation will be delivered using an online tool (YrselTräning)

  • Standard care (written instructions leaflet)Other

    For those randomized to the control group, a 6 weeks duration standard vestibular rehabilitation will be delivered using a written instructions leaflet

Study groups in NCT05056324
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Device: Online vestibular rehabilitation tool
Control groupActive comparatorNot described
Receives: Other: Standard care (written instructions leaflet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The between group mean Vertigo Symptom Scale Short Form (VSS-SF) score difference

    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.

    Measured: 6 weeks after vertigo onset

Secondary outcomes (11)

  1. The between groups mean Dizziness Handicap Inventory (DHI) score

    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.

    Measured: 6 weeks and 3 months after vertigo onset

  2. The between groups changes in timed 25-foot walk test (T25-FW)); body sway during standing and walking; and the mobility

    Measured: From baseline to 6 weeks and 3 months

  3. The between groups changes in video head impulse test (vHIT, site-dependent)

    Measured: 6 weeks and 3 months after vertigo onset

  4. The between groups changes in video head impulse test (vHIT, site-dependent) measured lateral canal VOR gain and saccades

    Measured: From baseline to 6 weeks and 3 months

  5. The between groups mean vertigo symptom scale short form (VSS-SF) score

    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.

    Measured: 12 months after vertigo onset

  6. The between group pedometer-derived mean weekly number of steps walked since last visit

    Measured: 3 months after vertigo onset

  7. The between groups mean number of weekly training sessions

    Measured: 6 weeks after vertigo onset

  8. Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave)

    Measured: 12 months

  9. The difference in kinematic output between measurement systems (i.e., multi-sensor and mobile app)

    Measured: Three months after symptom onset

  10. The reliability of the Swedish VSS-SF translation

    Measured: Six weeks after symptom onset

  11. The frequency of BPPV at 6 weeks and 3 months after AVS onset using a BPPV specific questionnaire and positional nystagmus tests

    Measured: 6 weeks and 3 months after vertigo onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2021
  2. Study start1 Oct 2021
  3. Primary completion1 Feb 2024
  4. Study completion12 Mar 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05056324
Sponsor's protocol ID
Web-based vertigo rehab
Other IDs
CIV-21-05-036744
Status last verified
Aug 2024
First submitted
7 Sep 2021
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35710448

  • 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.

    PubMed 39928092

  • Surano S, Lindell E, Mathe J, Davidsson H, Tomanovic T, Bjurman M, Faergemann E, Ledin T, Rostmark A, Grip H, Ohberg F, Granasen G, Salzer J. Internet-based vestibular rehabilitation versus written instructions after acute vertigo: A randomised controlled trial. PLoS One. 2026 Jun 12;21(6):e0351092. doi: 10.1371/journal.pone.0351092. eCollection 2026.

    PubMed 42284306

Questions about this trial

What is this clinical trial studying?

A study testing Online vestibular rehabilitation tool in people with Acute Vestibular Syndrome, run by Umeå University at 9 sites in Sweden.

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 5 inclusion and 5 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Sweden. 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?

The between group mean Vertigo Symptom Scale Short Form (VSS-SF) score difference (time frame: 6 weeks after vertigo onset). 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 NCT05056324, which also lists 3 linked publications.

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 30 Mar 2025.

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