The primary objective is to study the impact of continuous vibrotactile feedback during waking hours in daily life on balance, (fear of) falling, fatigue, and overall functioning. The secondary objective is to study the impact of a vibrotactile…
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 outcome is the experienced mobility and balance in daily life which
will be measured by means of the Mobility and Balance Score (MBS), a score
between 0 and 10.
Secondary outcome
Secondary study outcomes are: NRS for general functioning, fear of falling,
fatigue, modified Clinical Test of Sensory Interaction, Dynamic Gait Index and
Timed Up and Go Test.
Background summary
For patients with severe bilateral vestibular loss it has been shown that
vibrotactile feedback provided by a *balance belt* was effective in improving
mobility and balance in daily living and quality of live. It is our hypothesis
that this could also be an effective aid for patients with uncompensated
unilateral vestibular hypofunction and persistent balance problems.
Study objective
The primary objective is to study the impact of continuous vibrotactile
feedback during waking hours in daily life on balance, (fear of) falling,
fatigue, and overall functioning. The secondary objective is to study the
impact of a vibrotactile feedback belt on static and dynamic balance and gait
in controlled laboratory conditions.
Study design
The study is designed as a single-case experiment (SCE) with a reversal design
and with randomization of phases.
Intervention
Each participant goes through a baseline phase, a sham phase (i.e., wearing the
BalanceBelt without it being switched on), and an intervention phase (i.e.,
wearing the BalanceBelt while it is switched on).
Study burden and risks
Following the risk classification of the NFU we rate the risk of this study to
be negligible. A potential benefit of the study is an improved balance and
functioning. If patients consent to enter the study, they follow the study
protocol which consist of an 8 weeks trial period. There are total of 9 contact
moments, of which four are mandatory at Gelre Hospitals location Apeldoorn.
During seven weeks participants are asked to fill in a daily diary (estimated
time 5 minutes/day). In addition, at visit 1 and 9, the participants will be
asked to fill in a questionnaire and three balance and gait tests will be done
(estimated time 90 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
- chronic (>3 months) unilateral vestibular hypofunction and balance complaints
- motivated to try the BalanceBelt
Exclusion criteria
- Presence of neurological, psychiatric or orthopaedic disorders, reduced
proprioceptive sensitivity or impaired vision which influences the postural
stability, PPPD.
- age <18 years
- not able to understand instructions and questionnaires in Dutch
- not willing/able to visit Gelre hospitals location Apeldoorn several times
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL84562.075.23 |