Web-based Rehab After Acute Vertigo

Not Applicable

Completed

• Conditions: Acute Vestibular Syndrome
• Interventions: Device: Online vestibular rehabilitation tool; Other: Standard care (written instructions leaflet)

• Registration Number: NCT05056324
• Lead Sponsor: Umeå University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-24
• Study Start: 2021-10-01
• Primary Completion: 2024-02-01
• Status Verified: 2024-08
• Study Completion: 2025-03-12
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Online vestibular rehabilitation tool	-
Control group	Standard care (written instructions leaflet)	-

Primary Outcome Measures

Name	Time	Method
The between group mean Vertigo Symptom Scale Short Form (VSS-SF) score difference	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 Outcome Measures

Name	Time	Method
The between groups changes in video head impulse test (vHIT, site-dependent)	6 weeks and 3 months after vertigo onset
The between groups mean Dizziness Handicap Inventory (DHI) score	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.
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) 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	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.
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 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
The difference in kinematic output between measurement systems (i.e., multi-sensor and mobile app)	Three months after symptom onset

Trial Locations

Locations (9)

Sollefteå Hospital; 🇸🇪 Sollefteå, Sweden

Sundsvall Hospital; 🇸🇪 Sundsvall, Sweden

University Hospital Umeå; 🇸🇪 Umeå, Sweden

University Hospital Linköping; 🇸🇪 Linköping, Sweden

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Södra Älvsborg Hospital; 🇸🇪 Borås, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Capio Sankt Görans Hospital; 🇸🇪 Stockholm, Sweden

Sunderby Hospital; 🇸🇪 Södra Sunderbyn, Sweden