The primary objective is to investigate the course of limitations in physical activity and daily functioning in patients who are diagnosed with unilateral or bilateral vestibular hypofunction, and to identify factors that are associated with this…
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the number of minutes spend on physical activity
per day as measured with the MOX Physical Activity Monitoring Sensor (MOX1).
Secondary outcome
Secondary study parameters are fatigue, perceived handicap due to dizziness,
balance confidence, patients specific complaints, level of visual vertigo,
avoidance of specific movements due to dizziness and/or unsteadiness and the
level of perceived recovery.
Background summary
The consequences of vestibular weakness in patients with vestibular
hypofunction are divers and therefore difficult to measure with a single
questionnaire or performance test. In patients who experience dizziness and
disequilibrium it is likely that this results in a decrease of physical
activities which is a disadvantageous for the patient*s recovery. Therefore, it
is important to gain more insight in the level and the course of physical
activities in patients with vestibular hypofunction. Another frequent complaint
in these patients t is fatigue. Nevertheless, fatigue has not been a focus in
clinical guidelines nor in vestibular research. Because of the diversity of the
complaints seen in patients with vestibular weakness and the current lack of
published research on this topic, we aim to get more insight in the course of
daily functioning, specifically in physical activity and fatigue.
Study objective
The primary objective is to investigate the course of limitations in physical
activity and daily functioning in patients who are diagnosed with unilateral or
bilateral vestibular hypofunction, and to identify factors that are associated
with this course. Secondary objectives are to investigate the presence and
course of fatigue in patients who are diagnosed with unilateral or bilateral
vestibular hypofunction and to assess the association between fatigue, severity
of dizziness, physical activity and dizziness related limitations in daily
functioning in these patients
Study design
A 6-month prospective, single-centre, observational cohort study.
Study burden and risks
If patients consent to enter the study, they will be invited to wear the MOX1
activity monitor for 7 days/24 hours a day at three time points (i.e. baseline,
3 months, 6 months). In addition the included patients will be asked to fill in
seven questionnaires at baseline, seven questionnaires at 3 months, and eight
questionnaires at 6 months follow-up. Estimated time to fill in the
questionnaires is 30 minutes. No other procedures will be performed for the
study (i.e., no invasive procedures, clinical tests, laboratory tests, etc.).
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
NL
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
NL
Listed location countries
Age
Inclusion criteria
- age 18 years or older
- patients at the Apeldoorns Dizziness Center
- diagnosed with unilateral or bilateral vestibular hypofunction
Exclusion criteria
- age <18 years
- not being able to weare the activity monitor at the upper leg en/or able to
walk
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77986.058.21 |