Web-based Rehab After Acute Vertigo

NCT05056324 | Completed

• 2 other identifiers: Web-based vertigo rehabCIV-21-05-036744
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 9

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.

Conditions

Acute Vestibular Syndrome

Keywords

acute vestibular syndrome; vertigo; vestibular rehabilitation

Outcome Measures

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.

  6 weeks after vertigo onset

Secondary Outcomes (11)

• The between groups mean Dizziness Handicap Inventory (DHI) score

  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

  12 months after vertigo onset

Other Outcomes (2)

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

  6 weeks, 3 months and 12 months

• The number of falls/fractures in each study arm

  6 weeks, 3 months and 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Device: Online vestibular rehabilitation tool

Control group

ACTIVE COMPARATOR

Other: Standard care (written instructions leaflet)

Interventions

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)

Intervention group

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (9)

Södra Älvsborg Hospital

Borås, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

University Hospital Linköping

Linköping, Sweden

Location

Sollefteå Hospital

Sollefteå, Sweden

Location

Sunderby Hospital

Södra Sunderbyn, Sweden

Location

Capio Sankt Görans Hospital

Stockholm, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Sundsvall Hospital

Sundsvall, Sweden

Location

University Hospital Umeå

Umeå, Sweden

Location

Related Publications (2)

• 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.

  PMID: 39928092 BACKGROUND

• 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.

  PMID: 35710448 BACKGROUND

MeSH Terms

Conditions

Vertigo

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jonatan Salzer, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 24, 2021
• Study Start: October 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: March 12, 2025
• Last Updated: March 30, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (9)