Dysfunction of Vestibular System Clinical Trial
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.
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
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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