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Conventional Versus Virtual Reality Based Vestibular Rehabilitation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beaumont Hospital
Emory University
Royal Victoria Eye and Ear Hospital
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier:
NCT01442623
First received: September 21, 2011
Last updated: July 24, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


Further study details as provided by Royal College of Surgeons, Ireland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 71
Study Start Date: February 2011
Estimated Study Completion Date: September 2013
Primary Completion Date: July 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:
  • Balance retraining
  • Virtual reality rehabilitation
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:
  • Balance retraining
  • Virtual reality rehabilitation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442623

Locations
Ireland
Beaumont Hospital
Dublin, Co. Dublin, Ireland, 9
Royal Victoria Eye and Ear Hospital
Dublin, Ireland, 2
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Beaumont Hospital
Emory University
Royal Victoria Eye and Ear Hospital
Investigators
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: July 24, 2013
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:
Vestibular Diseases
Ear Diseases
Labyrinth Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014