AzTrials
AzTrials

Dysfunction of Vestibular SystemNCT01344408

Effectiveness of Computer Assisted Training for Older People With Vestibular Dysfunction

A study testing Computer-training in people with Dysfunction of Vestibular System, run by University of Aarhus at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dysfunction of Vestibular System
What is being tested?
Computer-training
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteDenmark
Study dates
Jan 2010to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Aarhus Hospital

    Aarhus, Aarhus C, 8000

Other trials in Denmark

About this study

Official title: Effectiveness of Computer Assisted Training in Vestibular Rehabilitation for Older Patients With Vestibular Dysfunction

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.

Read more

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

Read the detailed description

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. Half of the elderly who incurs hip fracture will never be able to walk like they did before the fall, and one year mortality is between 15 and 25%. Meanwhile, the population 65 years old and older are increasing and the National Institute of Aging notes in a 2001 report that the world's population of 65 years old and older is growing by 800.000 a year. It is estimated that the cost of fall-related accidents in 2020 will reach $54.9 billion in the U.S. alone.

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. A study in 6785 participants included the National Health and Nutrition Examination Surveys in the U.S. showed that the prevalence of vestibular dysfunction increases significantly with age. The prevalence for vestibular dysfunction among participants aged 60-69 years was 49.4%, 68,7% among participants aged 70-79 and 84,8% for the participants aged 80 years or older.

In patients with vestibular dysfunction, vestibular rehabilitation (VR) can reduce fall risk. In 2007 a large Cochrane review compared randomized studies of VR, where the authors concluded that there is moderate to strong evidence of the efficacy of VR. Several authors describe that the reduction of the patient's dizziness in VR only can be achieved by simultaneous establishment of daily exercises at home. 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). The program has been successfully used for home training of patients with cerebral palsy and is composed of exercises that are both motivating and guiding.

Based on individual studies and tests therapists developed a personalized rehabilitation program permanently corrected, modified and adjusted for vestibular dysfunction patients. The system could generate feedback to the therapists at hospital with information about the person's daily training time. Basic element in MITII is an exercise. As an example the exercise could be to catch an insect with a net using head movements. Management method is drag-and-drop, which means that management of the network is done by the user with a colour which can retain and move objects on the screen.

PURPOSE

The study 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

METHODS

The study consists of three parts:

  1. A randomized study where the aim is to examine whether Mitii can improve the outcome of vestibular rehabilitation.The study includes 31 patients in a control and 32 patients in a intervention group with vestibular dysfunction. The control group undergoing normal rehabilitation in the fall clinic (ie, 2 times weekly rehabilitation in the fall clinic + home exercise program with printed instructions) while the intervention group undergoes rehabilitation with MITII (ie 2 times weekly rehabilitation in the fall clinic + MITII to support home exercises. The expectation is that the intervention group improve the most.
  2. After completion of the rehabilitation period the patients must maintain their functionality by home exercises. The patients in the intervention group keeps MITII in further 12 weeks to compare with control group of patients who have had a traditional exercise program as printed instructions available. The expectation is that the intervention group will be able to maintain their functionality best.
  3. The last part of the study will be qualitative to study how the elderly feel about using IT support in their own homes. This qualitative study will consist of interviews of 7 patients included in the intervention group.

STUDY POPULATION Patients referred to the fall clinic from their GP or Casualty department, Aarhus University Hospital. A geriatric doctor will examine and evaluate what underlies the patient's fall issue. The patients who are diagnosed by vestibular dysfunction and are accepting to take part of the project, refers to the Ear, nose and throat department H, Aarhus University Hospital for verification of the vestibular dysfunction.

Being tested
Computer-training
Keywords
Dizziness, rehabilitation, geriatric, IT-technology
Medical subject headings
Dizziness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer-trainingProcedure or surgery

    Also called Move It To Improve IT

    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

Study groups in NCT01344408
Study groupRoleWhat they receive
Computer-trainingExperimentalThe 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.
Receives: Procedure: Computer-training
Printed instructionsExperimentalA training program delivered as printed instructions
Receives: Procedure: Computer-training

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Static balance

    Measured: 16 weeks of rehabilitation

Secondary outcomes (7)
  1. Dynamic balance will be measured by the "Dynamic Gait Index"

    Dynamic balance

    Measured: 8, 16 and 28 weeks of rehabilitation

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

    Experienced dizziness handicap

    Measured: 8, 16 and 28 weeks of rehabilitation

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

    Static balance

    Measured: 8, 16 and 28 weeks of rehabilitation

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

    Quality of life

    Measured: 8, 16 and 28 weeks of rehabilitation

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

    Under extremities strength testing

    Measured: 8, 16 and 28 weeks of rehabilitation

  6. Motion triggered dizziness will be measured by the "Motion Sensitivity Test"

    Motion triggered dizziness

    Measured: 8, 16 and 28 weeks of rehabilitation

  7. Dizziness will be measured by the "Visual Analogue Scale"

    Dizziness scores on the Visual Analogue Scale

    Measured: 8, 16 and 28 weeks of rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01344408
Sponsor's protocol ID
M-20090189
Status last verified
Oct 2015
First submitted
15 Mar 2010
Last updated
20 May 2016
Results posted
No
Data monitoring committee
No

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. doi: 10.1002/14651858.CD000340.

    PubMed 14583918
  • 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.

    PubMed 2017229
  • 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.

    PubMed 15113307
  • 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.

    PubMed 19468085
  • 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.

    PubMed 16143174
  • Brandt T. Management of vestibular disorders. J Neurol. 2000 Jul;247(7):491-9. doi: 10.1007/s004150070146.

    PubMed 10993488
  • 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.

    PubMed 17943853
  • 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.

    PubMed 12601321
  • 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.

    PubMed 11818183
  • 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.

    PubMed 16506876
  • 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.

    PubMed 16640469
  • 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.

    PubMed 15316804
  • 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.

    PubMed 26981283
  • 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.

    PubMed 25450134

Questions about this trial

What is this clinical trial studying?

A study testing Computer-training in people with Dysfunction of Vestibular System, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static balance will be measured by the "One leg Stand test" (time frame: 16 weeks of rehabilitation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01344408, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in