Conventional Versus Virtual Reality Based Vestibular Rehabilitation

NCT01442623 | Completed Phase 2

• 1 other identifier: RoyalCSI DMeldrum
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Peripheral Vestibular Disease

Keywords

Vestibular Rehabilitation; Balance; Virtual Reality; Gait; Dizziness

Outcome Measures

Primary Outcomes (1)

• Gait Speed (metres per second)

  Gait speed will be measured using a 5-camera Vicon™ computerised three dimensional gait analysis system.

  8 weeks

Secondary Outcomes (6)

• Computerised Dynamic Posturography

  8 weeks

• Vestibular Rehabilitation Benefit Questionnaire

  8 weeks

• Hospital Anxiety and Depression Score

  8 weeks

• Dynamic Visual Acuity

  8 weeks

• Activities Balance Confidence Questionnaire

  8 weeks

Study Arms (2)

Conventional Vestibular Rehabilitation

ACTIVE COMPARATOR

Six week program of conventional vestibular rehabilitation.

Other: Vestibular Rehabilitation

Nintendo Wii Vestibular Rehabilitation

EXPERIMENTAL

Six week program of vestibular rehabilitation using the Nintendo Wii Fit Plus.

Other: Vestibular Rehabilitation

Interventions

Vestibular Rehabilitation OTHER

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.

Also known as: Balance retraining, Virtual reality rehabilitation

Conventional Vestibular Rehabilitation; Nintendo Wii Vestibular Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Beaumont Hospital: collaborator
• Emory University: collaborator
• Royal Victoria Eye and Ear Hospital: collaborator

Study Sites (2)

Beaumont Hospital

Dublin, Co. Dublin, 9, Ireland

Location

Royal Victoria Eye and Ear Hospital

Dublin, 2, Ireland

Location

Related Publications (16)

• Curthoys IS. Vestibular compensation and substitution. Curr Opin Neurol. 2000 Feb;13(1):27-30. doi: 10.1097/00019052-200002000-00006.

  PMID: 10719646 BACKGROUND

• Hillier SL, McDonnell M. Vestibular rehabilitation for unilateral peripheral vestibular dysfunction. Clin Otolaryngol. 2011 Jun;36(3):248-9. doi: 10.1111/j.1749-4486.2011.02309.x. No abstract available.

  PMID: 21752206 BACKGROUND

• Schubert MC, Migliaccio AA, Clendaniel RA, Allak A, Carey JP. Mechanism of dynamic visual acuity recovery with vestibular rehabilitation. Arch Phys Med Rehabil. 2008 Mar;89(3):500-7. doi: 10.1016/j.apmr.2007.11.010.

  PMID: 18295629 BACKGROUND

• Morris AE, Lutman ME, Yardley L. Measuring outcome from Vestibular Rehabilitation, Part I: Qualitative development of a new self-report measure. Int J Audiol. 2008 Apr;47(4):169-77. doi: 10.1080/14992020701843129.

  PMID: 18389412 BACKGROUND

• Morris AE, Lutman ME, Yardley L. Measuring outcome from vestibular rehabilitation, part II: refinement and validation of a new self-report measure. Int J Audiol. 2009 Jan;48(1):24-37. doi: 10.1080/14992020802314905.

  PMID: 19173111 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Parry SW, Steen N, Galloway SR, Kenny RA, Bond J. Falls and confidence related quality of life outcome measures in an older British cohort. Postgrad Med J. 2001 Feb;77(904):103-8. doi: 10.1136/pmj.77.904.103.

  PMID: 11161077 BACKGROUND

• Teggi R, Caldirola D, Fabiano B, Recanati P, Bussi M. Rehabilitation after acute vestibular disorders. J Laryngol Otol. 2009 Apr;123(4):397-402. doi: 10.1017/S0022215108002983. Epub 2008 Jun 13.

  PMID: 18549515 BACKGROUND

• Meldrum D, McConn Walsh R. Vestibular Rehabilitatin IN: Stokes M, Stack E. Physical management in neurological rehabilitation. 3rd ed. Edinburgh: Elsevier; 2011.

  BACKGROUND

• Viirre E, Sitarz R. Vestibular rehabilitation using visual displays: preliminary study. Laryngoscope. 2002 Mar;112(3):500-3. doi: 10.1097/00005537-200203000-00017.

  PMID: 12148861 BACKGROUND

• Cooksey FS. Rehabilitation in Vestibular Injuries. Proc R Soc Med. 1946 Mar;39(5):273-8. doi: 10.1177/003591574603900523. No abstract available.

  PMID: 19993269 BACKGROUND

• Nitz JC, Kuys S, Isles R, Fu S. Is the Wii Fit a new-generation tool for improving balance, health and well-being? A pilot study. Climacteric. 2010 Oct;13(5):487-91. doi: 10.3109/13697130903395193.

  PMID: 19905991 BACKGROUND

• Herdman S. Vestibular rehabilitation. 3rd ed. Philadelphia: F.A. Davis; 2007.

  BACKGROUND

• Burdea, G. & Coiffet, P. (2003) Virtual Reality Technology, New Jersey, Wiley and Sons.

  BACKGROUND

• Meldrum D, Herdman S, Vance R, Murray D, Malone K, Duffy D, Glennon A, McConn-Walsh R. Effectiveness of conventional versus virtual reality-based balance exercises in vestibular rehabilitation for unilateral peripheral vestibular loss: results of a randomized controlled trial. Arch Phys Med Rehabil. 2015 Jul;96(7):1319-1328.e1. doi: 10.1016/j.apmr.2015.02.032. Epub 2015 Apr 2.

  PMID: 25842051 DERIVED

• Meldrum D, Herdman S, Moloney R, Murray D, Duffy D, Malone K, French H, Hone S, Conroy R, McConn-Walsh R. Effectiveness of conventional versus virtual reality based vestibular rehabilitation in the treatment of dizziness, gait and balance impairment in adults with unilateral peripheral vestibular loss: a randomised controlled trial. BMC Ear Nose Throat Disord. 2012 Mar 26;12:3. doi: 10.1186/1472-6815-12-3.

  PMID: 22449224 DERIVED

Related Links

• Hain T ( Accessed 2011)

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dara Meldrum, MSc.

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

• Susan J Herdman, PhD

  Emory University

  STUDY DIRECTOR

• Rory McConn-Walsh, MD

  Royal College of Surgeons in Ireland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 28, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

IE (2)