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Vestibular Rehabilitation for Strokepatients With Dizziness

Primary Purpose

Stroke, Dizziness

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Vestibular rehabilitation
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Dizziness, Vestibular rehabiliation, Balance

Eligibility Criteria

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

Inclusion Criteria

• First time stroke with dizziness -

Exclusion Criteria

  • Not first time stroke
  • No dizziness

Sites / Locations

  • Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vestibular rehabiliation

Control group

Arm Description

Vestibular rehabiliation

Usual rehabilitation whitout additional vestibular exercises

Outcomes

Primary Outcome Measures

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.
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
The Berg Balance Scale
Balance measures

Secondary Outcome Measures

Full Information

First Posted
February 20, 2013
Last Updated
June 8, 2018
Sponsor
Lund University
Collaborators
Region Skåne, Primary health care, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01797744
Brief Title
Vestibular Rehabilitation for Strokepatients With Dizziness
Official Title
Vestibular Rehabilitation for Strokepatients With Dizziness - a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Region Skåne, Primary health care, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dizziness
Keywords
Stroke, Dizziness, Vestibular rehabiliation, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular rehabiliation
Arm Type
Experimental
Arm Description
Vestibular rehabiliation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual rehabilitation whitout additional vestibular exercises
Intervention Type
Other
Intervention Name(s)
Vestibular rehabilitation
Intervention Description
Usual rehabilitation and four different vestibular rehabilitation exercises, adapted to the individual patient
Primary Outcome Measure Information:
Title
The Activities-specific Balance Confidence Scale
Description
Questionnaire. The ABC-scale has proven to be able to identify the influence that vestibular dysfunction can have on daily activities.
Time Frame
Change between baseline and three months after baseline
Title
EuroQol 5D
Description
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
Time Frame
Change between baseline and three months after baseline
Title
The Berg Balance Scale
Description
Balance measures
Time Frame
Change between baseline and three months after baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria • First time stroke with dizziness - Exclusion Criteria Not first time stroke No dizziness
Facility Information:
Facility Name
Lund University
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://www.med.lu.se
Description
University official website

Learn more about this trial

Vestibular Rehabilitation for Strokepatients With Dizziness

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