Peripheral Vestibular Disease Clinical Trial
Official title:
Conventional Versus Virtual Reality Based Vestibular Rehabilitation; Effect on Dizziness, Gait and Balance
Dizziness is a common and disabling symptom and is associated with unsteadiness in both standing and walking, sometimes resulting in falls. People who have any of these problems often have a disease process affecting the inner ear. A proportion of people will recover spontaneously over time; those that do not may benefit from a specialized form of physiotherapy known as vestibular rehabilitation. This consists of exercise regimes that are individualized to each person depending on their problems. These regimes aim to decrease dizziness, help patients to re-learn movement patterns and improve their balance during standing and walking. There is considerable research supporting vestibular rehabilitation but it is not clear what is the best type, setting or frequency of treatment. How therapy impacts on walking ability is also not clear. Recent developments have suggested that force plate and virtual reality therapies may benefit. This form of therapy can provide feedback that is unavailable with conventional exercises. Exposure to virtual environments can challenge balance which helps to retrain it. The aim of this study is to compare conventional vestibular rehabilitation with a force plate/virtual reality therapy based vestibular rehabilitation, using a universally available virtual reality system (Nintendo Wii Fit Plus®). In this study, consenting patients with a vestibular disorder will be assigned randomly to either a conventional treatment or a virtual reality based treatment that is customized to their individual problems. They will receive treatment for 8 weeks. The effects of treatment will be measured by state of the art computerized analysis of walking and balance. Questionnaires that obtain information about how severe their dizziness is will also be administered. The study will help therapists understand how inner ear problems affect walking and balance. It will also provide information on the optimum method of providing vestibular rehabilitation and thus improve patient care.
Unilateral vestibular disease results in vertigo, dizziness, dysequilibrium and gait
problems. Recovery results from a process known as vestibular compensation where visual and
proprioceptive inputs are upregulated, or remaining vestibular function is recalibrated and
utilised more effectively (Curthoys, 2000). Patients who do not compensate remain
significantly impaired. They benefit from specialised assessment and treatment techniques
collectively referred to as vestibular rehabilitation (Hillier and McDonnell, 2011). This
form of rehabilitation has its roots in the empirical work of Cawthorne and Cooksey, who in
the 1940's first documented the important role of exercise in recovery after a vestibular
injury (Cooksey, 1945) and more recently in studies investigating vestibular adaptation
(Schubert et al., 2008). Vestibular rehabilitation programs can be considered as motor
learning programs and thus require practice and feedback. In conventional rehabilitation it
is difficult for patients to gain feedback of performance performing balance exercise which
can be repetitive and boring. Force plate technology has been used in the clinical setting to
provide visual and auditory feedback and has shown some promising results (Teggi et al.,
2009). Virtual reality, defined as 'a high-end-computer interface that involves real time
simulation and interactions through multiple sensorial channels' (Burdea and Coiffet, 2003)
is also being investigated in laboratory settings. There is some support for the use of
virtual reality in vestibular rehabilitation (Viirre and Sitarz, 2002) but these technologies
are presently prohibitively expensive and are not universally available. They require
considerable therapist time and are unlikely to be used with the frequency that is required
for motor learning (particularly in vestibular rehabilitation where most programs entail
daily exercise). Recent developments in the gaming industry have resulted in the Nintendo Wii
® Fit Plus, which combines a force platform with an accelerometer to provide visual and
auditory feedback of subjects' centre of gravity during virtual reality exercises and games.
It stimulates movement and perturbs balance in order to retrain it. Use of this low cost
gaming system could easily be adapted to meet the requirements of a vestibular rehabilitation
program. The system allows for accurate monitoring of use in terms of time and frequency
which is an area that has proven difficult to monitor in both research and clinical
applications due to inaccurate patient recall. It is fun to use and therefore may be
motivating patients. The rehabilitation community is beginning to investigate this technology
in the area of balance retraining (Nitz et al. 2009). Anecdotal reports indicate the Wii is
being used in vestibular rehabilitation (Hain, 2011) but as yet no randomised controlled
trials exist.
It is important to measure the effect of this technology which can easily be incorporated
into the home environment and compare it to conventional treatment before it can be
recommended for use. In tandem with this is also important to gain some insights into patient
satisfaction with both treatments.
Aim To compare the outcome from conventional vestibular rehabilitation to virtual reality
based vestibular rehabilitation in the treatment of unilateral vestibular disease.
Objectives To compare the effect of conventional vestibular rehabilitation and virtual
reality based rehabilitation on gait.
To compare the effect of conventional vestibular rehabilitation and virtual reality based
rehabilitation on subjective complaints of dizziness/vertigo.
To compare the effect of conventional vestibular rehabilitation and virtual reality based
rehabilitation on balance.
To compare the effect of conventional vestibular rehabilitation and virtual reality based
vestibular rehabilitation on dynamic visual acuity.
To quantify patient satisfaction with conventional and virtual reality based vestibular
rehabilitation.
Trial design
The study design will be an assessor blinded randomised controlled trial. There is moderate
to strong evidence in the literature for the efficacy of vestibular rehabilitation, therefore
a "no" treatment group is not deemed ethical.
Participants
Patients attending the otolaryngology and neurology outpatient clinics in Beaumont Hospital
or the Royal Victoria Eye and Ear Hospital will be invited to participate in the trial.
Sample Size Calculation.
Allowing for a 10% drop out, a maximum of 48 participants will need to be recruited for each
group (at 80% power to detect p<0.05 on all outcomes). A two year recruitment period is
required.
The inclusion criteria will be;
- Clinical diagnosis of peripheral vestibular dysfunction and no other neurological
deficit (confirmed where possible with vestibular function testing; canal paresis >20%).
- One of the following subjective complaints indicating a failure of vestibular
compensation; disequilibrium, gait instability, vertigo/dizziness, motion sensitivity.
- Not taking medication for vertigo or willing to discontinue with permission from
consultant physician.
The exclusion criteria will be;
- Bilateral peripheral vestibular pathology.
- CNS involvement.
- Fluctuating Symptoms (Meniere's disease, migrainous vertigo) or active BPPV.
- Other medical conditions in the acute phase (orthopaedic injury).
- Previous vestibular rehabilitation.
- Pacemaker, Epilepsy (as per Nintendo Wii Guidelines).
- Unwilling or unable to use a Nintendo Wii.
Randomisation
Following baseline assessments participants will be randomised to one of two groups;
1. Conventional vestibular rehabilitation
2. Virtual reality vestibular rehabilitation A third party (not involved in the day to day
running of the trial) will use an online randomisation program to assign participants to
either conventional treatment or virtual reality treatment in advance of recruitment.
The treating physiotherapist will be informed of group allocation after consent has been
obtained and after baseline assessments are completed.
Intervention
Based on current evidence in the literature a time frame of up to 6 treatments over 8 weeks
will be provided. The interventions for both groups are based on six identified core elements
of vestibular rehabilitation used in current clinical practice- education, relaxation,
adaptation exercises, habituation exercises, balance and gait retraining and re-conditioning
(Meldrum and McConn Walsh, 2011). Programs will be customised to each participant depending
on their presenting symptoms and impairments, and will be progressive. All participants will
be asked to perform a home exercise program daily for 30 minutes. Where participants are
deemed at risk of falling, they will be provided with the necessary preventative
instructions. Participants in the virtual reality group will be instructed in the use of the
Nintendo Wii ® and will be given one on loan. They will be provided with a customised program
which is the virtual reality equivalent of conventional exercises. Those in the conventional
group will be provided with a foam balance mat. Participants will be seen weekly for
re-assessment, progression of exercises and advice.
Measurement of compliance with home treatment
All participants will be provided with a diary to record compliance with the home exercise
program. The Nintendo Wii ® fit plus records type, duration and frequency of exercises and
this will also be used as the record for the virtual reality group.
Data will be entered and coded in Microsoft Excel and statistical analysis will be performed
using PASW and Stata 11. Intention to treat analysis will be performed. Data will be examined
for normality and if a normal distribution is observed t-tests, and an ANOVA model will be
used for analysis of interval data with an adjustment for baseline values. The non-parametric
equivalent will be used where data are not normally distributed or are non-parametric.
Differences from baseline will be calculated for primary and secondary outcomes within groups
and between groups at each time point. A significance level of p<0.05 will be set. Effect
sizes for within and between groups comparison will be calculated.
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