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Web-based Rehab After Acute Vertigo

Primary Purpose

Acute Vestibular Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Online vestibular rehabilitation tool
Standard care (written instructions leaflet)
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Vestibular Syndrome focused on measuring acute vestibular syndrome, vertigo, vestibular rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥18 years old
  • The subject has given written consent to participate in the study
  • 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 screening (between 24 hours and 7 days from onset) spontaneously, gaze-evoked or head-shake evoked and videofrenzel documented
  • Screening and inclusion within 7 days of onset of continuous symptoms
  • 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
  • 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
  • Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
  • 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
  • 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, bensodiazepins, neuroleptics. Transient corticosteroid and/or antiemetic treatment related to the current vertigo is accepted.

Sites / Locations

  • Södra Älvsborg HospitalRecruiting
  • Sahlgrenska University HospitalRecruiting
  • University Hospital LinköpingRecruiting
  • Skåne University Hospital
  • Sollefteå HospitalRecruiting
  • Capio Sankt Görans HospitalRecruiting
  • Karolinska University HospitalRecruiting
  • Sundsvall HospitalRecruiting
  • Sunderby HospitalRecruiting
  • University Hospital UmeåRecruiting
  • Östersund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
The between groups changes in timed 25-foot walk test (T25-FW)); body sway during standing and walking; and the mobility
The between groups changes in video head impulse test (vHIT, site-dependent)
The between groups changes in video head impulse test (vHIT, site-dependent) measured lateral canal VOR gain and saccades
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.
The between group pedometer-derived mean weekly number of steps walked since last visit
The between groups mean number of weekly training sessions
Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave)
The difference in kinematic output between measurement systems (i.e., multi-sensor and mobile app)
The reliability of the Swedish VSS-SF translation
The frequency of BPPV at 6 weeks and 3 months after AVS onset using a BPPV specific questionnaire and positional nystagmus tests

Full Information

First Posted
September 7, 2021
Last Updated
August 28, 2023
Sponsor
Umeå University
Collaborators
University Hospital, Umeå, Sundsvall Hospital, Sahlgrenska University Hospital, Sweden, Västernorrland County Council, Sweden, Region Jämtland Härjedalen, Skane University Hospital, Södra Älvsborg Hospital, Karolinska University Hospital, University Hospital, Linkoeping, Sunderby Hospital, Capio Sankt Görans Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05056324
Brief Title
Web-based Rehab After Acute Vertigo
Official Title
Internet-based Vestibular Rehabilitation Versus Standard Care After Acute Onset Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
University Hospital, Umeå, Sundsvall Hospital, Sahlgrenska University Hospital, Sweden, Västernorrland County Council, Sweden, Region Jämtland Härjedalen, Skane University Hospital, Södra Älvsborg Hospital, Karolinska University Hospital, University Hospital, Linkoeping, Sunderby Hospital, Capio Sankt Görans Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Vestibular Syndrome
Keywords
acute vestibular syndrome, vertigo, vestibular rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Online vestibular rehabilitation tool
Intervention Description
For those randomized to the intervention group, a 6 weeks duration vestibular rehabilitation will be delivered using an online tool (YrselTräning)
Intervention Type
Other
Intervention Name(s)
Standard care (written instructions leaflet)
Intervention Description
For those randomized to the control group, a 6 weeks duration standard vestibular rehabilitation will be delivered using a written instructions leaflet
Primary Outcome Measure Information:
Title
The between group mean Vertigo Symptom Scale Short Form (VSS-SF) score difference
Description
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.
Time Frame
6 weeks after vertigo onset
Secondary Outcome Measure Information:
Title
The between groups mean Dizziness Handicap Inventory (DHI) score
Description
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.
Time Frame
6 weeks and 3 months after vertigo onset
Title
The between groups changes in timed 25-foot walk test (T25-FW)); body sway during standing and walking; and the mobility
Time Frame
From baseline to 6 weeks and 3 months
Title
The between groups changes in video head impulse test (vHIT, site-dependent)
Time Frame
6 weeks and 3 months after vertigo onset
Title
The between groups changes in video head impulse test (vHIT, site-dependent) measured lateral canal VOR gain and saccades
Time Frame
From baseline to 6 weeks and 3 months
Title
The between groups mean vertigo symptom scale short form (VSS-SF) score
Description
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.
Time Frame
12 months after vertigo onset
Title
The between group pedometer-derived mean weekly number of steps walked since last visit
Time Frame
3 months after vertigo onset
Title
The between groups mean number of weekly training sessions
Time Frame
6 weeks after vertigo onset
Title
Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave)
Time Frame
12 months
Title
The difference in kinematic output between measurement systems (i.e., multi-sensor and mobile app)
Time Frame
Three months after symptom onset
Title
The reliability of the Swedish VSS-SF translation
Time Frame
Six weeks after symptom onset
Title
The frequency of BPPV at 6 weeks and 3 months after AVS onset using a BPPV specific questionnaire and positional nystagmus tests
Time Frame
6 weeks and 3 months after vertigo onset
Other Pre-specified Outcome Measures:
Title
The proportion of participants who has experienced falls/fractures since study start
Time Frame
6 weeks, 3 months and 12 months
Title
The number of falls/fractures in each study arm
Time Frame
6 weeks, 3 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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, bensodiazepins, neuroleptics. Transient corticosteroid and/or antiemetic treatment related to the current vertigo is accepted.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonatan Salzer, MD, PhD
Phone
+46 70 267 89 64
Email
jonatan.salzer@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonatan Salzer, MD, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Södra Älvsborg Hospital
City
Borås
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Lindell, MD, PhD
Facility Name
Sahlgrenska University Hospital
City
Göteborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Davidsson, MD
Facility Name
University Hospital Linköping
City
Linköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torbjörn Ledin, MD, PhD
Facility Name
Skåne University Hospital
City
Skåne
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Tjernström, MD, PhD
Facility Name
Sollefteå Hospital
City
Sollefteå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Bjurman, PT
Facility Name
Capio Sankt Görans Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Mathé, MD, PhD
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatjana Tomanovic, MD, PhD
Facility Name
Sundsvall Hospital
City
Sundsvall
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Faergemann, MD
Facility Name
Sunderby Hospital
City
Södra Sunderbyn
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anette Sörlin, MD
Facility Name
University Hospital Umeå
City
Umeå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Solmaz Surano, MD, PhD
Facility Name
Östersund Hospital
City
Östersund
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linn Wedlund, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35710448
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.
Results Reference
derived

Learn more about this trial

Web-based Rehab After Acute Vertigo

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