Clinical trial NCT05056324: Web-based Rehab After Acute Vertigo
Official title: Internet-based Vestibular Rehabilitation Versus Standard Care After Acute Onset Vertigo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Vestibular Syndrome
Keywords: acute vestibular syndrome
vertigo
vestibular rehabilitation
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University Hospital, Umeå
name: Sundsvall Hospital
name: Sahlgrenska University Hospital
name: Västernorrland County Council, Sweden
name: Södra Älvsborg Hospital
name: Karolinska University Hospital
name: University Hospital, Linkoeping
name: Sunderby Hospital
name: Capio Sankt Görans Hospital
First posted: 2021-09-24
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The between group mean Vertigo Symptom Scale Short Form (VSS-SF) score difference
timeFrame: 6 weeks after vertigo onset
Secondary outcomes:
measure: The between groups mean Dizziness Handicap Inventory (DHI) score
timeFrame: 6 weeks and 3 months after vertigo onset
measure: The between groups changes in timed 25-foot walk test (T25-FW)); body sway during standing and walking; and the mobility
timeFrame: From baseline to 6 weeks and 3 months
measure: The between groups changes in video head impulse test (vHIT, site-dependent)
timeFrame: 6 weeks and 3 months after vertigo onset
measure: The between groups changes in video head impulse test (vHIT, site-dependent) measured lateral canal VOR gain and saccades
timeFrame: From baseline to 6 weeks and 3 months
measure: The between groups mean vertigo symptom scale short form (VSS-SF) score
timeFrame: 12 months after vertigo onset
measure: The between group pedometer-derived mean weekly number of steps walked since last visit
timeFrame: 3 months after vertigo onset
measure: The between groups mean number of weekly training sessions
timeFrame: 6 weeks after vertigo onset
measure: Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave)
timeFrame: 12 months
measure: The difference in kinematic output between measurement systems (i.e., multi-sensor and mobile app)
timeFrame: Three months after symptom onset
measure: The reliability of the Swedish VSS-SF translation
timeFrame: Six weeks after symptom onset
measure: The frequency of BPPV at 6 weeks and 3 months after AVS onset using a BPPV specific questionnaire and positional nystagmus tests
timeFrame: 6 weeks and 3 months after vertigo onset
Other outcomes:
measure: The proportion of participants who has experienced falls/fractures since study start
timeFrame: 6 weeks, 3 months and 12 months
measure: The number of falls/fractures in each study arm
timeFrame: 6 weeks, 3 months and 12 months
Locations:
city: Borås
country: Sweden
facility: Södra Älvsborg Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linköping
country: Sweden
facility: University Hospital Linköping
city: Sollefteå
country: Sweden
facility: Sollefteå Hospital
city: Stockholm
country: Sweden
facility: Capio Sankt Görans Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
city: Södra Sunderbyn
country: Sweden
facility: Sunderby Hospital
city: Umeå
country: Sweden
facility: University Hospital Umeå
Study officials:
affiliation: Umeå University
name: Jonatan Salzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.