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Web-based Rehab After Acute Vertigo

U

Umeå University

Status

Completed

Conditions

Acute Vestibular Syndrome

Treatments

Device: Online vestibular rehabilitation tool
Other: Standard care (written instructions leaflet)

Study type

Interventional

Funder types

Other

Identifiers

NCT05056324
CIV-21-05-036744 (Other Identifier)
Web-based vertigo rehab

Details and patient eligibility

About

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.

Enrollment

184 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

184 participants in 2 patient groups

Intervention group
Experimental group
Treatment:
Device: Online vestibular rehabilitation tool
Control group
Active Comparator group
Treatment:
Other: Standard care (written instructions leaflet)

Trial contacts and locations

9

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Central trial contact

Jonatan Salzer, MD, PhD

Data sourced from clinicaltrials.gov

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