Web-based Rehab After Acute Vertigo

Acute Vestibular Syndrome Clinical Trial

Official title:

Internet-based Vestibular Rehabilitation Versus Standard Care After Acute Onset Vertigo

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
• 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
• 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.

Related Conditions & MeSH terms

• Acute Vestibular Syndrome
• Dizziness
• Vertigo
• Vestibular Diseases

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