Trial document




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  DRKS00006243

Trial Description

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Title

Fall risk and fall-related morbidity among patients with vertigo and balance disorders

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Gait and balance disturbances are common features in patients with vertigo and balance disorders, suggesting an increased tendency to fall. However, little is known about the risk of falling in these patients. Systematic investigations of the frequency and causes of falls could help to develop specific prevention strategies, that would be of high clinical importance.
This study aims to detect the annual rate of falls and fall-related injuries among patients with vertigo and balance disorders and to identify fall risk factors.

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Brief Summary in Scientific Language

Patients with vestibular deficits of different etiologies often present with several forms of vertigo, postural imbalance and impaired gait performance, suggesting an increased tendency to fall. However, little is known about the risk of falling in these patients.
This study aims to detect the incidence of falls and fall-related injuries among patients with vertigo and balance disorders and to identify fall risk factors.
A multifactorial fall assessment (see American Geriatrics Society 2011) will be conducted at baseline. It consists of the following dimensions: frequency of previous falls and fall factors, stance and gait performance, acute and chronic concomitant diseases, medication, physical functioning (particularly muscle strength of the lower extremities, cardiovascular functioning), visual acuity, cognitive functioning, performance of the activities of daily living and quality of life. The follow-up will be conducted over a period of 12 months. The frequency of falls and related injuries will be assessed by means of a falls calendar and monthly telephone interviews.
We expect that particularly those patients with central vertigo and balance disorders are prone to falling and that several risk factors, especially factors related to posture and gait control, can be identified.

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Organizational Data

  •   DRKS00006243
  •   2014/06/20
  •   [---]*
  •   yes
  •   Approved
  •   047-13, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   H81.4 -  Vertigo of central origin
  •   H81.3 -  Other peripheral vertigo
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Interventions/Observational Groups

  •   In patients with central and peripheral vestibular disorders frequency of falls and fall-related factors (questionnaire according to the Hopkins Falls Grading Scale [Davalos-Bichara M et al. Development and validation of a Falls-Grading Scale. J Geriatr Phys Ther. 2012; 35:1-5]), gait and balance performance (gait analysis and posturography), cognitive funtioning (MOCA), fear of falling (Falls Efficacy Scale-International, Activities-specific Balance Confidence Scale) and health-related quality of life (SF-36) will be assessed. Incidence of falls will then be documented over a period of 12 month by a falls calender and monthly telephone interviews (according to the catogories of the Hopkins Falls Grading Scale).
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Incidence of falls (questionnaire according to the categories of the Hopkins Falls Grading Scale, at baseline and by monthly telephone interviews during a follow-up-period of one year)

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Secondary Outcome

Fall-related morbidity (questionnaire according to the categories of the Hopkins Falls Grading Scale, at baseline and by monthly telephone interviews during a follow-up-period of one year);
Fear of falling (questionnaire: Falls Efficacy Scale-International, at baseline);
Balance and gait performance (gait analysis using a pressure-sensitive carpet [GaitRite] and stance analysis using a stabilometer platform [Kistler], at baseline)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/07/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Clear primary diagnosis, written informed consent, cooperation ability of the patient

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Exclusion Criteria

Other disease that presents with gait disturbance (pareses of the lower extremities after stroke, multiple sclerosis, spinal canal stenosis, etc; hip- or knee-replacement within the preceding 6 months), subjects being incapable of giving informed consent

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Addresses

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    • Klinikum der Universität München, Campus Großhadern
    • Mr.  Prof. Dr.  Klaus  Jahn 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern
    • Ms.  Cornelia  Schlick 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Campus Großhadern
    • Ms.  Cornelia  Schlick 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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