Effectiveness of Computer Assisted Training for Older People With Vestibular Dysfunction

NCT01344408 | Unknown

• 1 other identifier: M-20090189
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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. The ph.d. consist of three studies which has the purposes: To compare a computer exercise program (Mitii) with conservative home-training according to printed instructions in the rehabilitation of patients with vistibular dysfunction in an outpatient clinic To investigate whether the effect of vestibular rehabilitation is preserved three months after the completion of supervised training in an outpatient clinic for specific vestibular rehabilitation and whether a computer assisted home training program (Mitii) is superior to printed instructions in this respect To evaluate patient experience and barriers for the use fo the computer assisted rehabilitation of patients with vestibular dysfunction

Conditions

Dysfunction of Vestibular System

Keywords

Dizziness; rehabilitation; geriatric; IT-technology

Outcome Measures

Primary Outcomes (1)

• Static balance will be measured by the "One leg Stand test"

  Static balance

  16 weeks of rehabilitation

Secondary Outcomes (7)

• Dynamic balance will be measured by the "Dynamic Gait Index"

  8, 16 and 28 weeks of rehabilitation

• Experienced dizziness handicap will be measured by the "Dizziness Handicap Inventory"

  8, 16 and 28 weeks of rehabilitation

• Static balance will be measured by the "Modified Clinical Test of Sensory Interaction and Balance".

  8, 16 and 28 weeks of rehabilitation

• Quality of life will be measured by the "SF-12"

  8, 16 and 28 weeks of rehabilitation

• Under extremities strength test will be measured by the "Chair Stand Test"

  8, 16 and 28 weeks of rehabilitation

Study Arms (2)

Computer-training

EXPERIMENTAL

The computer-training program, Move it to improve it was installed in the participants homes using an internet-connected computer with a web camera connected to a cloud-based specifically adapted interactive training program.

Procedure: Computer-training

Printed instructions

EXPERIMENTAL

A training program delivered as printed instructions

Procedure: Computer-training

Interventions

Computer-training PROCEDURE

The computer-training program "Move IT To Improve IT" is a exercise program which is installed and used on a Apple Imac in the patients home to support vestibular rehabilitation

Also known as: Move It To Improve IT

Computer-training; Printed instructions

Eligibility Criteria

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

You may qualify if:

• Patient Acceptance
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus Hospital

Aarhus, Aarhus C, 8000, Denmark

Location

Related Publications (14)

• 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. doi: 10.1002/14651858.CD000340.

  PMID: 14583918 BACKGROUND

• 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. doi: 10.1056/NEJM199105093241905.

  PMID: 2017229 BACKGROUND

• Pothula VB, Chew F, Lesser TH, Sharma AK. Falls and vestibular impairment. Clin Otolaryngol Allied Sci. 2004 Apr;29(2):179-82. doi: 10.1111/j.0307-7772.2004.00785.x.

  PMID: 15113307 BACKGROUND

• 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. doi: 10.1001/archinternmed.2009.66.

  PMID: 19468085 BACKGROUND

• Macias JD, Massingale S, Gerkin RD. Efficacy of vestibular rehabilitation therapy in reducing falls. Otolaryngol Head Neck Surg. 2005 Sep;133(3):323-5. doi: 10.1016/j.otohns.2005.04.024.

  PMID: 16143174 BACKGROUND

• Brandt T. Management of vestibular disorders. J Neurol. 2000 Jul;247(7):491-9. doi: 10.1007/s004150070146.

  PMID: 10993488 BACKGROUND

• Hillier SL, Hollohan V. Vestibular rehabilitation for unilateral peripheral vestibular dysfunction. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005397. doi: 10.1002/14651858.CD005397.pub2.

  PMID: 17943853 BACKGROUND

• 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. doi: 10.1067/mhn.2003.72.

  PMID: 12601321 BACKGROUND

• 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. doi: 10.1016/s0749-3797(01)00413-5.

  PMID: 11818183 BACKGROUND

• 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.

  PMID: 16506876 BACKGROUND

• 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. doi: 10.1089/cpb.2006.9.152.

  PMID: 16640469 BACKGROUND

• Pavlou M, Lingeswaran A, Davies RA, Gresty MA, Bronstein AM. Simulator based rehabilitation in refractory dizziness. J Neurol. 2004 Aug;251(8):983-95. doi: 10.1007/s00415-004-0476-2.

  PMID: 15316804 BACKGROUND

• Smaerup M, Laessoe U, Gronvall E, Henriksen JJ, Damsgaard EM. The Use of Computer-Assisted Home Exercises to Preserve Physical Function after a Vestibular Rehabilitation Program: A Randomized Controlled Study. Rehabil Res Pract. 2016;2016:7026317. doi: 10.1155/2016/7026317. Epub 2016 Feb 11.

  PMID: 26981283 DERIVED

• Smaerup M, Gronvall E, Larsen SB, Laessoe U, Henriksen JJ, Damsgaard EM. Computer-assisted training as a complement in rehabilitation of patients with chronic vestibular dizziness--a randomized controlled trial. Arch Phys Med Rehabil. 2015 Mar;96(3):395-401. doi: 10.1016/j.apmr.2014.10.005. Epub 2014 Oct 25.

  PMID: 25450134 DERIVED

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

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

Study Officials

• E.M. Damsgaard

  Geriatric Section

  STUDY CHAIR

• M. Brandt

  Geriatric Section

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: April 29, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2015-10

Locations

DK (1)