Overview

This trial is active, not recruiting.

Condition dysfunction of vestibular system
Treatment computer-training
Sponsor University of Aarhus
Start date January 2010
End date December 2016
Trial size 63 participants
Trial identifier NCT01344408, M-20090189

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
computer-training 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
(Experimental)
A training program delivered as printed instructions
computer-training 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

Primary Outcomes

Measure
Static balance will be measured by the "One leg Stand test"
time frame: 16 weeks of rehabilitation

Secondary Outcomes

Measure
Dynamic balance will be measured by the "Dynamic Gait Index"
time frame: 8, 16 and 28 weeks of rehabilitation
Experienced dizziness handicap will be measured by the "Dizziness Handicap Inventory"
time frame: 8, 16 and 28 weeks of rehabilitation
Static balance will be measured by the "Modified Clinical Test of Sensory Interaction and Balance".
time frame: 8, 16 and 28 weeks of rehabilitation
Quality of life will be measured by the "SF-12"
time frame: 8, 16 and 28 weeks of rehabilitation
Under extremities strength test will be measured by the "Chair Stand Test"
time frame: 8, 16 and 28 weeks of rehabilitation
Motion triggered dizziness will be measured by the "Motion Sensitivity Test"
time frame: 8, 16 and 28 weeks of rehabilitation
Dizziness will be measured by the "Visual Analogue Scale"
time frame: 8, 16 and 28 weeks of rehabilitation

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Effectiveness of Computer Assisted Training in Vestibular Rehabilitation for Older Patients With Vestibular Dysfunction
Principal investigator M. Brandt
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.