Conventional Versus Virtual Reality Based Vestibular Rehabilitation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Vestibular Disease |
Other: Vestibular Rehabilitation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Conventional Versus Virtual Reality Based Vestibular Rehabilitation; Effect on Dizziness, Gait and Balance |
- Gait Speed (metres per second) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Gait speed will be measured using a 5-camera Vicon™ computerised three dimensional gait analysis system.
- Computerised Dynamic Posturography [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Balance will be assessed using computerised dynamic posturography (Equitest, Neurocom).
- Vestibular Rehabilitation Benefit Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The Vestibular Rehabilitation Benefit Questionnaire (Morris et al 2008,2009) is a validated 22 item, 3 part questionnaire that allows participants to rate their dizziness and how it is affecting their quality of life. Clinically meaningful change has been established on the subscores and total scores on this questionnaire.
- Hospital Anxiety and Depression Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983) is a validated scale that has been used previously in studies in vestibular rehabilitation and assesses non-somatic symptoms of anxiety and depression. Scores range between 0 and 21 on each subscale, scores between 8 and 10 are considered borderline and those above ten indicate clinical depression or anxiety
- Dynamic Visual Acuity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Dynamic visual acuity (DVA) is a measure of how clearly participants can see as their head is moving (a role of the vestibular system). DVA will be measured using Micromedical's™ DVA system of head horizontal plance rotations of 50/100/150 degrees per second and will be compared to static visual acuity.
- Activities Balance Confidence Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The Activities Balance Confidence Questionnaire (Parry et al 2001) is a 16 item questionnaire which asks a participant to rate their balance confidence on a range of activities of daily living.
- Patient Satisfaction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]This is a 15 item questionnaire which asks a participant to rate their satisfaction with the treatment program they underwent in the study, addressing difficulty, motivation, compliance, tiredness after exercise,and enjoyment of the program.
| Estimated Enrollment: | 96 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Conventional Vestibular Rehabilitation
Six week program of conventional vestibular rehabilitation.
|
Other: Vestibular Rehabilitation
The patients in the Nintendo Wii Vestibular Rehabilitation group will undergo a standardised 6 week program of vestibular rehabilitation using the Nintendo Wii Fit Plus at home 5 times a week. They will perform a series of exercises and games on the Wii Fit Plus that are designed to challenge and retrain balance. They will be seen once a week by a physiotherapist for review and progression of exercises. Patients in the Conventional Vestibular Rehabilitation group will undergo a standardised program of conventional vestibular rehabilitation using conventional balance exercises (Herdman 2007) 5 times a week. They will be seen once a week by a physiotherapist to progress exercises and will receive a standardised home exercise program. Other Names:
|
|
Experimental: Nintendo Wii Vestibular Rehabilitation
Six week program of vestibular rehabilitation using the Nintendo Wii Fit Plus.
|
Other: Vestibular Rehabilitation
The patients in the Nintendo Wii Vestibular Rehabilitation group will undergo a standardised 6 week program of vestibular rehabilitation using the Nintendo Wii Fit Plus at home 5 times a week. They will perform a series of exercises and games on the Wii Fit Plus that are designed to challenge and retrain balance. They will be seen once a week by a physiotherapist for review and progression of exercises. Patients in the Conventional Vestibular Rehabilitation group will undergo a standardised program of conventional vestibular rehabilitation using conventional balance exercises (Herdman 2007) 5 times a week. They will be seen once a week by a physiotherapist to progress exercises and will receive a standardised home exercise program. Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Dara Meldrum, MSc. | 00-353-1-4022370 | dmeldrum@rcsi.ie |
| Ireland | |
| Beaumont Hospital | Recruiting |
| Dublin, Co. Dublin, Ireland, 9 | |
| Contact: Dara Meldrum, MSc. 00-353-1-4022370 dmeldrum@rcsi.ie | |
| Principal Investigator: Deirdre Murray, BSc. | |
| Sub-Investigator: Roisin Moloney, BSc. | |
| Sub-Investigator: Kareena Finucane, BSc. | |
| Royal Victoria Eye and Ear Hospital | Recruiting |
| Dublin, Ireland, 2 | |
| Contact: Douglas Duffy, DPT 0035316644600 doug.duffy@yahoo.com | |
| Principal Investigator: Stephen Hone, M.Ch. FRCSI | |
| Sub-Investigator: Douglas Duffy, DPT | |
| Principal Investigator: | Dara Meldrum, MSc. | Royal College of Surgeons in Ireland |
| Study Director: | Susan J Herdman, PhD | Emory University |
| Study Director: | Rory McConn-Walsh, MD | Royal College of Surgeons in Ireland |
More Information
Additional Information:
Publications:
| Responsible Party: | Royal College of Surgeons, Ireland |
| ClinicalTrials.gov Identifier: | NCT01442623 History of Changes |
| Other Study ID Numbers: | RoyalCSI DMeldrum |
| Study First Received: | September 21, 2011 |
| Last Updated: | November 16, 2011 |
| Health Authority: | Ireland: Medical Ethics Research Committee |
Keywords provided by Royal College of Surgeons, Ireland:
|
Vestibular Rehabilitation Balance Virtual Reality Gait Dizziness |
Additional relevant MeSH terms:
|
Vertigo Vestibular Diseases Labyrinth Diseases Ear Diseases |
Otorhinolaryngologic Diseases Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013