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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01344408
First received: March 15, 2010
Last updated: October 15, 2012
Last verified: October 2012
  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:


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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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 July 28, 2014