StrokeNCT01797744
Vestibular Rehabilitation for Strokepatients With Dizziness
A study testing Vestibular rehabilitation in people with Stroke and Dizziness, run by Lund University at 1 site in Sweden.
Trial summary
Recently, the investigators has shown that dizziness is common among patients with first time stroke and that it affects self perceived health. There are indications that vestibular rehabilitation can have effect of neurological causes of dizziness and vertigo and it therefore seems important to find out if vestibular… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Vestibular rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First time stroke with dizziness -
Who cannot join
- Not first time stroke
- No dizziness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vestibular Rehabilitation for Strokepatients With Dizziness - a Randomized Controlled Trial.
Recently, the investigators has shown that dizziness is common among patients with first time stroke and that it affects self perceived health. There are indications that vestibular rehabilitation can have effect of neurological causes of dizziness and vertigo and it therefore seems important to find out if vestibular rehabilitation can affect dizziness among patients with stroke.
The aim of this study is to find out if vestibular rehabilitation can have any effect on function, balance and self-rated health among patients with first time stroke.
- Being tested
- Vestibular rehabilitation
- Keywords
- Stroke, Dizziness, Vestibular rehabiliation, Balance
- Medical subject headings
- Stroke, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitationOther
Usual rehabilitation and four different vestibular rehabilitation exercises, adapted to the individual patient
| Study group | Role | What they receive |
|---|---|---|
| Vestibular rehabiliation | Experimental | Vestibular rehabiliation Receives: Other: Vestibular rehabilitation |
| Control group | No intervention | Usual rehabilitation whitout additional vestibular exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Activities-specific Balance Confidence Scale
Questionnaire. The ABC-scale has proven to be able to identify the influence that vestibular dysfunction can have on daily activities.
Measured: Change between baseline and three months after baseline
EuroQol 5D
Questionnaire. EQ5D consists of a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems, severe problems. The patient indicates his/her state by marking the most appropriate statement. This result in a 1-digit number and the digits for the five dimensions can be combined in a five-digit number, generating 243 possible combinations of response.The EQ5D also consist of the EQ VAS where the patients' record self-rated health on a vertical, visual analogue scale where the individual points can be used as a quantitative measure with zero as worst rated health and 100 as best rated health
Measured: Change between baseline and three months after baseline
The Berg Balance Scale
Balance measures
Measured: Change between baseline and three months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Principal investigator, Eva Ekvall-Hansson, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797744
- Sponsor's protocol ID
- 2012/816
- Status last verified
- Jun 2018
- First submitted
- 20 Feb 2013
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Rehabilitation for Strokepatients With Dizziness - a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01797744
- Acronym / sponsor ID
- 2012/816
- Keywords
- Stroke, Dizziness, Vestibular rehabiliation, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- Feb 2013
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, the investigators has shown that dizziness is common among patients with first time stroke and that it affects self perceived health. There are indications that vestibular rehabilitation can have effect of neurological causes of dizziness and vertigo and it therefore seems important to find out if vestibular rehabilitation can affect dizziness among patients with stroke.
The aim of this study is to find out if vestibular rehabilitation can have any effect on function, balance and self-rated health among patients with first time stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular rehabiliation | Experimental | Other: Vestibular rehabilitationVestibular rehabiliation |
| Control group | No intervention | –Usual rehabilitation whitout additional vestibular exercises |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First time stroke with dizziness -
Key exclusion criteria (2 listed)
- Not first time stroke
- No dizziness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular rehabilitationUsual rehabilitation and four different vestibular rehabilitation exercises, adapted to the individual patient | Other | Vestibular rehabiliation |
Primary outcome
The Activities-specific Balance Confidence Scale
Time frame: Change between baseline and three months after baseline
Questionnaire. The ABC-scale has proven to be able to identify the influence that vestibular dysfunction can have on daily activities.
EuroQol 5D
Time frame: Change between baseline and three months after baseline
Questionnaire. EQ5D consists of a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems, severe problems. The patient indicates his/her state by marking the most appropriate statement. This result in a 1-digit number and the digits for the five dimensions can be combined in a five-digit number, generating 243 possible combinations of response.The EQ5D also consist of the EQ VAS where the patients' record self-rated health on a vertical, visual analogue scale where the individual points can be used as a quantitative measure with zero as worst rated health and 100 as best rated health
The Berg Balance Scale
Time frame: Change between baseline and three months after baseline
Balance measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- University official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular rehabilitation in people with Stroke and Dizziness, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Activities-specific Balance Confidence Scale (time frame: Change between baseline and three months after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.