CClinicalTrials.gg
CompletedNCT05056324Updated Mar 30, 2025

Web-based Rehab After Acute Vertigo

An interventional study of Online vestibular rehabilitation tool and Standard care (written instructions leaflet) in Acute Vestibular Syndrome, sponsored by Umeå University. Completed at 9 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by Umeå University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Vestibular Syndrome

Keywords

  • acute vestibular syndrome
  • vertigo
  • vestibular rehabilitation
03

In context

Vertigo

248 studies on the registry are indexed under Vertigo; 39 are open to participants now.

This study's enrollment of 184 is above the median of 57 across 186 interventional studies indexed under Vertigo.

Browse Vertigo studies →

Lead sponsor

Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
184 participants (actual)

Study arms

  • Experimental
    Intervention group

    Device: Online vestibular rehabilitation tool

  • Active comparator
    Control group

    Other: Standard care (written instructions leaflet)

Interventions

  • DeviceOnline vestibular rehabilitation tool

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

  • OtherStandard care (written instructions leaflet)

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 6 weeks after vertigo onset

Secondary outcomes

  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.

    Time frame: 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

    Time frame: From baseline to 6 weeks and 3 months

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

    Time frame: 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

    Time frame: 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.

    Time frame: 12 months after vertigo onset

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

    Time frame: 3 months after vertigo onset

  7. The between groups mean number of weekly training sessions

    Time frame: 6 weeks after vertigo onset

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

    Time frame: 12 months

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

    Time frame: Three months after symptom onset

  10. The reliability of the Swedish VSS-SF translation

    Time frame: 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

    Time frame: 6 weeks and 3 months after vertigo onset

Other outcomes

  1. The proportion of participants who has experienced falls/fractures since study start

    Time frame: 6 weeks, 3 months and 12 months

  2. The number of falls/fractures in each study arm

    Time frame: 6 weeks, 3 months and 12 months

07

Study locations

9 sites
  • Södra Älvsborg Hospital
    Borås, Sweden
  • Sahlgrenska University Hospital
    Göteborg, Sweden
  • University Hospital Linköping
    Linköping, Sweden
  • Sollefteå Hospital
    Sollefteå, Sweden
  • Capio Sankt Görans Hospital
    Stockholm, Sweden
  • Karolinska University Hospital
    Stockholm, Sweden
  • Sundsvall Hospital
    Sundsvall, Sweden
  • Sunderby Hospital
    Södra Sunderbyn, Sweden
  • University Hospital Umeå
    Umeå, Sweden
08

References and documents

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. PubMed 39928092 ↗
  • 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05056324
Lead sponsor
Umeå University
Collaborators
University Hospital, Umeå, Sundsvall Hospital, Sahlgrenska University Hospital, Västernorrland County Council, Sweden, Södra Älvsborg Hospital, Karolinska University Hospital, University Hospital, Linkoeping, Sunderby Hospital, Capio Sankt Görans Hospital
Responsible party
Sponsor
First posted
Sep 24, 2021
Start date
Oct 1, 2021
Primary completion
Feb 1, 2024
Completion
Mar 12, 2025
Last update
Mar 30, 2025

Study contacts

Jonatan Salzer, MD, PhD
principal investigator · Umeå University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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