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Vestibular Rehabilitation for Strokepatients With Dizziness

This study is currently recruiting participants.
Verified March 2013 by Lund University
Sponsor:
Collaborator:
Primary Health Care
Information provided by (Responsible Party):
Eva Ekvall Hansson, Lund University
ClinicalTrials.gov Identifier:
NCT01797744
First received: February 20, 2013
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Stroke
Dizziness
 Other: Vestibular rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Vestibular Rehabilitation for Strokepatients With Dizziness - a Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University:

Primary Outcome Measures:
  • The Activities-specific Balance Confidence Scale [ Time Frame: Change between baseline and three months after baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Balance measures


Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vestibular rehabiliation
Vestibular rehabiliation
 Other: Vestibular rehabilitation
Usual rehabilitation and four different vestibular rehabilitation exercises, adapted to the individual patient
No Intervention: Control group
Usual rehabilitation whitout additional vestibular exercises

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

• First time stroke with dizziness -

Exclusion Criteria

  • Not first time stroke
  • No dizziness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01797744

Contacts
Contact: Eva Ekvall Hansson, Associate professor +4640391358 eva.ekvall-hansson@med.lu.se
Contact: Liselott Persson, PhD +46462229555 liselott.persson@med.lu.se

Locations
Sweden
Lund University Recruiting
Malmö, Sweden, 205 02
Contact: Eva Ekvall Hansson, Associate professor     +4640391358     eva.ekvall-hansson@med.lu.se    
Contact: Liselott Persson, PhD     +46462229555     liselott.persson@med.lu.se    
Principal Investigator: Eva Ekvall Hansson, PhD, PT            
Sponsors and Collaborators
Lund University
Primary Health Care
  More Information

Additional Information:
University official website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eva Ekvall Hansson, Associate professor, Lund University
ClinicalTrials.gov Identifier: NCT01797744     History of Changes
Other Study ID Numbers: 2012/816
Study First Received: February 20, 2013
Last Updated: March 1, 2013
Health Authority: Sweden: Regional Ethical Review Board in Lund

Keywords provided by Lund University:
Stroke
Dizziness
Vestibular rehabiliation
Balance

Additional relevant MeSH terms:
Dizziness
Vertigo
Stroke
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vestibular Diseases
 Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013