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Completed

NCT Number: NCT05056324

Web-based Rehab After Acute 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.

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Key information

Conditions

Acute Vestibular Syndrome Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Södra Älvsborg Hospital, Borås, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Online vestibular rehabilitation tool

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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

    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.

  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

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Capio Sankt Görans Hospital
  • Karolinska University Hospital
  • Sahlgrenska University Hospital
  • Sunderby Hospital
  • Sundsvall Hospital
  • Södra Älvsborg Hospital
  • University Hospital, Linkoeping
  • University Hospital, Umeå
  • Västernorrland County Council, Sweden

Registry information

Official study title

Internet-based Vestibular Rehabilitation Versus Standard Care After Acute Onset Vertigo

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 24, 2021
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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