NCT01797744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 11, 2018

Status Verified

June 1, 2018

Enrollment Period

5.3 years

First QC Date

February 20, 2013

Last Update Submit

June 8, 2018

Conditions

Keywords

StrokeDizzinessVestibular rehabiliationBalance

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    Change between baseline and three months after baseline

  • The Berg Balance Scale

    Balance measures

    Change between baseline and three months after baseline

Study Arms (2)

Vestibular rehabiliation

EXPERIMENTAL

Vestibular rehabiliation

Other: Vestibular rehabilitation

Control group

NO INTERVENTION

Usual rehabilitation whitout additional vestibular exercises

Interventions

Usual rehabilitation and four different vestibular rehabilitation exercises, adapted to the individual patient

Vestibular rehabiliation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First time stroke with dizziness -

You may not qualify if:

  • Not first time stroke
  • No dizziness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Malmo, 205 02, Sweden

Location

Related Links

MeSH Terms

Conditions

StrokeDizziness

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 22, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 11, 2018

Record last verified: 2018-06

Locations