IT-support for Home Training in Rehabilitation of Geriatric Patients With Vestibular Dysfunction - Full Text View

Purpose

BACKGROUND A Cochrane review from 2003 found that about 30% of people 65 years or older each year fall and that number is even higher for elder people living in institutions. Falls are the cause of 95% of all hip fractures, resulting in prolonged hospitalization and prolonged disability. In patients who are referred to the emergency room after unexplained fall, a study of 564 patients showed that 80% of the patients had vestibular symptoms characterized by balance problems, nausea, impairment, vomiting, and dizziness. 41% of the patients had dizziness suggesting a dysfunctional vestibular system called vestibular dysfunction. In patients with vestibular dysfunction, vestibular rehabilitation (VR) can reduce fall risk. Several studies show however that the elderly has a decreased compliance in relation to the performance of home exercise.

A solution to support the older vestibular rehabilitation process and to maintain the achieved level of functionality after the rehabilitation process is the computer-training program "Move It To Improve It" (MITII). Based on individual studies and tests therapists develop a personalized rehabilitation program permanently corrected, modified and adjusted. The system generates feedback to the therapists at hospital with information about the person's daily training and scores of individual exercises. The Web cam makes it possible to make video footage and pictures to be used in the feedback information. The system also establish direct communication between users and therapists. The web community provide the framework for a telerehabilitation system, which means that the hospital can service more users in the same period.

HYPOTHESIS Vestibular rehabilitation in 8 and 16 weeks with support of home training with MITII will result in improved function, balance and quality of life and reduction of experienced vertigo and dizziness handicap compared with 8 and 16 weeks of vestibular rehabilitation without IT support.

Condition	Intervention	Phase
Dysfunction of Vestibular System	Procedure: IT-technology	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	IT-support for Home Training in Rehabilitation of Geriatric Patients With Vestibular Dysfunction - a Clinical Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Dizziness and Vertigo Rehabilitation

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Static balance will be measured by the "One leg Stand test" [ Time Frame: 16 weeks of rehabilitation ] [ Designated as safety issue: Yes ]
Static balance

Secondary Outcome Measures:

Dynamic balance will be measured by the "Dynamic Gait Index" [ Time Frame: 8, 16 and 28 weeks of rehabilitation ] [ Designated as safety issue: Yes ]
Dynamic balance
Experienced dizziness handicap will be measured by the "Dizziness Handicap Inventory" [ Time Frame: 8, 16 and 28 weeks of rehabilitation ] [ Designated as safety issue: Yes ]
Experienced dizziness handicap
Static balance will be measured by the "Modified Clinical Test of Sensory Interaction and Balance". [ Time Frame: 8, 16 and 28 weeks of rehabilitation ] [ Designated as safety issue: Yes ]
Static balance
Quality of life will be measured by the "SF-12" [ Time Frame: 8, 16 and 28 weeks of rehabilitation ] [ Designated as safety issue: Yes ]
Quality of life
Under extremities strength test will be measured by the "Chair Stand Test" [ Time Frame: 8, 16 and 28 weeks of rehabilitation ] [ Designated as safety issue: Yes ]
Under extremities strength testing
Motion triggered dizziness will be measured by the "Motion Sensitivity Test" [ Time Frame: 8, 16 and 28 weeks of rehabilitation ] [ Designated as safety issue: Yes ]
Motion triggered dizziness
Dizziness will be measured by the "Visual Analogue Scale" [ Time Frame: 8, 16 and 28 weeks of rehabilitation ] [ Designated as safety issue: Yes ]
Dizziness scores on the Visual Analogue Scale

Estimated Enrollment:	58
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IT-technology	Procedure: IT-technology The IT-programme "Move IT To Improve IT" is a exercise program which is installed and used on a Apple Imac in the patients home to support 16 weeks of vestibular rehabilitation Other Name: Move It To Improve IT
Active Comparator: Vestibular rehabilitation without IT-technology	Procedure: IT-technology The IT-programme "Move IT To Improve IT" is a exercise program which is installed and used on a Apple Imac in the patients home to support 16 weeks of vestibular rehabilitation Other Name: Move It To Improve IT

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Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient Acceptance
65 years old or older
Peripheral vestibular dysfunction, stable (ie no inflammatory processes ie neuronitis vestibulitis and/or fluctuations symptoms ie Meniere)
Central vestibular dysfunction without other co-morbidities (eg. Parkinson's, Stroke)
Mixed peripheral and central vestibular dysfunction without other co-morbidity

Exclusion Criteria:

Lack of vision
If exercise therapy is contraindicated
Significant cardiac problems
Taking medicine with risk of vestibular side effects (benzodiazepines, sedatives)
Dementia (MMSE test <27 or an anamnesis suggesting dementia)
Stroke within the past 6 months
Other cognitive dysfunction
Operation of hip fractures within the last 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344408

Locations

Denmark
Aarhus Hospital	Recruiting
Aarhus, Aarhus C, Denmark, 8000
Contact: Michael Brandt +45 28705777 michbran@rm.dk

Sponsors and Collaborators

University of Aarhus

Investigators

Study Chair:	E.M. Damsgaard	Geriatric Section
Principal Investigator:	M. Brandt	Geriatric Section

More Information

Publications:

Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2003;(4):CD000340. Review.

Grisso JA, Kelsey JL, Strom BL, Chiu GY, Maislin G, O'Brien LA, Hoffman S, Kaplan F. Risk factors for falls as a cause of hip fracture in women. The Northeast Hip Fracture Study Group. N Engl J Med. 1991 May 9;324(19):1326-31.

Pothula VB, Chew F, Lesser TH, Sharma AK. Falls and vestibular impairment. Clin Otolaryngol Allied Sci. 2004 Apr;29(2):179-82.

Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. Erratum in: Arch Intern Med. 2009 Aug 10;169(15):1419.

Macias JD, Massingale S, Gerkin RD. Efficacy of vestibular rehabilitation therapy in reducing falls. Otolaryngol Head Neck Surg. 2005 Sep;133(3):323-5.

Brandt T. Management of vestibular disorders. J Neurol. 2000 Jul;247(7):491-9. Review.

Hillier SL, Hollohan V. Vestibular rehabilitation for unilateral peripheral vestibular dysfunction. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005397. Review. Update in: Cochrane Database Syst Rev. 2011;2:CD005397.

Krebs DE, Gill-Body KM, Parker SW, Ramirez JV, Wernick-Robinson M. Vestibular rehabilitation: useful but not universally so. Otolaryngol Head Neck Surg. 2003 Feb;128(2):240-50.

van der Bij AK, Laurant MG, Wensing M. Effectiveness of physical activity interventions for older adults: a review. Am J Prev Med. 2002 Feb;22(2):120-33. Review.

Forkan R, Pumper B, Smyth N, Wirkkala H, Ciol MA, Shumway-Cook A. Exercise adherence following physical therapy intervention in older adults with impaired balance. Phys Ther. 2006 Mar;86(3):401-10.

Whitney SL, Sparto PJ, Hodges LF, Babu SV, Furman JM, Redfern MS. Responses to a virtual reality grocery store in persons with and without vestibular dysfunction. Cyberpsychol Behav. 2006 Apr;9(2):152-6.

Pavlou M, Lingeswaran A, Davies RA, Gresty MA, Bronstein AM. Simulator based rehabilitation in refractory dizziness. J Neurol. 2004 Aug;251(8):983-95.

Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01344408 History of Changes
Other Study ID Numbers:	M-20090189
Study First Received:	March 15, 2010
Last Updated:	October 15, 2012
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: Ethics Committee Denmark: National Board of Health

Keywords provided by University of Aarhus:

Dizziness
rehabilitation
geriatric
IT-technology

ClinicalTrials.gov processed this record on May 16, 2013