Web-based Rehab After Acute Vertigo

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Vestibular Syndrome

Intervention / Treatment
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* Device: Online vestibular rehabilitation tool
* Other: Standard care (written instructions leaflet)


Participation Criteria
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Eligibility Criteria
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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, bensodiazepins, neuroleptics. Transient corticosteroid and/or antiemetic treatment related to the current vertigo is accepted.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Device: Online vestibular rehabilitation tool<br>* For those randomized to the intervention group, a 6 weeks duration vestibular rehabilitation will be delivered using an online tool (YrselTräning)<br>|
| Active Comparator: Control group<br> | Other: Standard care (written instructions leaflet)<br>* For those randomized to the control group, a 6 weeks duration standard vestibular rehabilitation will be delivered using a written instructions leaflet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks after vertigo onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 |  | From baseline to 6 weeks and 3 months | 
| The between groups changes in video head impulse test (vHIT, site-dependent) |  | 6 weeks and 3 months after vertigo onset | 
| The between groups changes in video head impulse test (vHIT, site-dependent) measured lateral canal VOR gain and saccades |  | From baseline to 6 weeks and 3 months | 
| 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. | 12 months after vertigo onset | 
| The between group pedometer-derived mean weekly number of steps walked since last visit |  | 3 months after vertigo onset | 
| The between groups mean number of weekly training sessions |  | 6 weeks after vertigo onset | 
| Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave) |  | 12 months | 
| The difference in kinematic output between measurement systems (i.e., multi-sensor and mobile app) |  | Three months after symptom onset | 
| The reliability of the Swedish VSS-SF translation |  | Six weeks after symptom onset | 
| The frequency of BPPV at 6 weeks and 3 months after AVS onset using a BPPV specific questionnaire and positional nystagmus tests |  | 6 weeks and 3 months after vertigo onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute vestibular syndrome, vertigo, vestibular rehabilitation