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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05056324
Other study ID # Web-based vertigo rehab
Secondary ID CIV-21-05-036744
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date February 1, 2025

Study information

Verified date May 2024
Source Umeå University
Contact Jonatan Salzer, MD, PhD
Phone +46 70 267 89 64
Email jonatan.salzer@umu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 184
Est. completion date February 1, 2025
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
Online vestibular rehabilitation tool
For those randomized to the intervention group, a 6 weeks duration vestibular rehabilitation will be delivered using an online tool (YrselTra¨ning)
Other:
Standard care (written instructions leaflet)
For those randomized to the control group, a 6 weeks duration standard vestibular rehabilitation will be delivered using a written instructions leaflet

Locations

Country Name City State
Sweden Södra Älvsborg Hospital Borås
Sweden Sahlgrenska University Hospital Göteborg
Sweden University Hospital Linköping Linköping
Sweden Östersund Hospital Östersund
Sweden Skåne University Hospital Skåne
Sweden Sunderby Hospital Södra Sunderbyn
Sweden Sollefteå Hospital Sollefteå
Sweden Capio Sankt Görans Hospital Stockholm
Sweden Karolinska University Hospital Stockholm
Sweden Sundsvall Hospital Sundsvall
Sweden University Hospital Umeå Umeå

Sponsors (12)

Lead Sponsor Collaborator
Umeå University Capio Sankt Görans Hospital, Karolinska University Hospital, Region Jämtland Härjedalen, Sahlgrenska University Hospital, Sweden, Skane University Hospital, Södra Älvsborg Hospital, Sunderby Hospital, Sundsvall Hospital, University Hospital, Linkoeping, University Hospital, Umeå, Västernorrland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other The proportion of participants who has experienced falls/fractures since study start 6 weeks, 3 months and 12 months
Other The number of falls/fractures in each study arm 6 weeks, 3 months and 12 months
Primary 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 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
Secondary 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
Secondary The between groups changes in video head impulse test (vHIT, site-dependent) 6 weeks and 3 months after vertigo onset
Secondary 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
Secondary 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
Secondary The between group pedometer-derived mean weekly number of steps walked since last visit 3 months after vertigo onset
Secondary The between groups mean number of weekly training sessions 6 weeks after vertigo onset
Secondary Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave) 12 months
Secondary The difference in kinematic output between measurement systems (i.e., multi-sensor and mobile app) Three months after symptom onset
Secondary The reliability of the Swedish VSS-SF translation Six weeks after symptom onset
Secondary 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
See also
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Recruiting NCT05062915 - Diagnostic Work up and Management of Acute Onset Vertigo N/A