Trial document





This trial has been registered retrospectively.
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  DRKS00007762

Trial Description

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Title

Assesment of the mobility and activity of patients with vertigo and dizziness

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Up to now, the effect of vertigo and balance disorders on the day-to-day mobility with or without falls and fall-associated restrictions has not been assessed. Aim of the study:
1) Assessment of mobility parameters and measures of physical activity in patients with different vestibular or non-vestibular vertigo and balance disorders
2) Assessment of the association of mobility parameters and measures of physical activity with occurrence of falls and related morbidity
Patients to be recruited:
Patients with vertigo and balance disorders of different etiology.
Course of the study:
During a single study visit at the study site we will measure gait and stance. Falls will be assessed as well as different questionnaires and scores (subjective evaluation of activity and mobility, general health questionnaire, test for dementia). We will attach a sensor (accelerometer) at the patient’s leg that shall measure daily activity for 14 days. Furthermore, we will instruct the patients to document falls for the following 12 months including monthly telephone interviews.

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Brief Summary in Scientific Language

Up to now, the effect of vertigo and balance disorders on the day-to-day mobility with or without falls, fall-associated morbidity and mortality has not been assessed. Especially for the benign course of disease of vertigo and balance disorders the assessment of disease-specific restrictions of activity and mobility in the daily life and the following reduction of disease-related quality of life is of central importance.
Aim of the study:
A) Assessment of mobility parameters and measures of physical activity in patients with different vestibular or non-vestibular vertigo and balance disorders
a. Do patients with vertigo and balance disorders show deviations in the day-to-day physical activity?
b. If yes: is there an association between (a) the entity of the disorder and (b) course of the disease (chronic vs. episodic vs. paroxysmal)?
c. Is there an association between mobility and physical activity in the patients?
B) Assessment of the association of mobility parameters and measures of physical activity with occurrence of falls and related morbidity
a. Is an increased risk of falls associated with manifest restrictions of the mobility or physical activity?
b. If yes: Can certain mobility parameters or measures of physical activity be used to predict the individual risk of falls?

Patients to be recruited:
1) Unilateral vestibular disorder (unilateral vestibulopathy, benign paroxysmal positional vertigo, Menière's disease, vestibular paroxysmia, perilymph fistula)
2) Bilateral vestibular disorder (bilateral vestibulopathy)
3) Somatoform vertigo (incl. phobic postural vertigo)
4) Central vestibular disorders (downbeat-nystagmus syndrome, cerebellar oculomotor disorders, Wallenberg syndrome, post infarction or craniocerebral injury)
5) Sensory vertigo (polyneuropathy, reduction of visus)
6) Normal subjects as controls

Patients will be recruited in the out-patient clinic of the German Center of Vertigo and Balance disorders (out of the clinical routine or out of its database).

Course of the study:
Investigations at the study site:
Gait and stance analysis (pait analysis (GaitRite), Timed up and go-Test, Functional Gait Assessment (FGA), posturography); systemic history of falls and near-falls; cognitive impairment (MoCA); clinical-neurological work-up, specific instrument-based diagnostics; history of other diseases and medication; questionnaires (health-related quality of life, concerns of falling)

Every participant will receive a mini sensor (accelerometer and goniometer) that will be attached at the patient’s thigh with a plaster. The sensor will be active 14 hours a day for 14 days. Data is stored within an internal SD-chip.

One-year follow-up of falls and near-falls using a diary (frequency of falling, severity of falls and trigger factors), additionally monthly interviews via telephone.

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Organizational Data

  •   DRKS00007762
  •   2015/04/21
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  •   yes
  •   Approved
  •   421-13, 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

  •   Meniere's disease, benign paroxysmal postuarl vertigo, perilymph fistula, bilateral vestibulopathy, unilateral vestubulopathy, cerebellar oculomotor disorder, Downbeatnystagmus syndrome, Wallenberg's syndrome, polyneuropathy, visus reduction, somatoform vertigo, phobic postural vertigo
  •   H81.0 -  Ménière disease
  •   H81.1 -  Benign paroxysmal vertigo
  •   H55 -  Nystagmus and other irregular eye movements
  •   H81.2 -  Vestibular neuronitis
  •   G62.9 -  Polyneuropathy, unspecified
  •   H54.9 -  Unspecified visual impairment (binocular)
  •   F45.8 -  Other somatoform disorders
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Interventions/Observational Groups

  •   Investigations at the study site:
    Gait and stance analysis (pait analysis (GaitRite), Timed up and go-Test, Functional Gait Assessment (FGA), posturography); systemic history of falls and near-falls; cognitive impairment (MoCA); clinical-neurological work-up, specific instrument-based diagnostics; history of other diseases and medication; questionnaires (health-related quality of life, concerns of falling)

    Every participant will receive a mini sensor (accelerometer and goniometer) that will be attached at the patient’s thigh with a plaster. The sensor will be active 14 hours a day for 14 days. Data is stored within an internal SD-chip.

    One-year follow-up of falls and near-falls using a diary (frequency of falling, severity of falls and trigger factors), additionally monthly interviews via telephone.
  •   Normal subjects as controls. Interventions and folow up will be eqal to arm 1.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Assessment of mobility parameters and measures of physical activity in patients with different vestibular or non-vestibular vertigo and balance disorders with the accelerometer data

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Secondary Outcome

Assessment of the association of mobility parameters and measures of physical activity with occurrence of falls and related morbidity with one-year-follow-up (falls diary and monthly telephone interview)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/01/29
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Arm 1: Distinct primary diagnosis, Age between 18 and 90 years, Written informed consent, Patient is able cooperate

Arm 2: no vertigo, dizziness or balance disorder, no sensory or motor deficit at the lower extremities, age between 18 and 90 years, written informed consent, patient is able to cooperate.

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Exclusion Criteria

Arm 1: Other diseases that cause a gait disorder (paresis of the lower extremity after stroke, multiple sclerosis, stenosis of the spinal canal etc.; insertion of a endoprosthesis within the preceding 6 months), deficits preventing informed consent

Arm 2: vertigo, dizziness or balance disorder; sensory deficits and weakness or other motor defitis of the lower extremity.

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Addresses

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    • Ludwigs-Maximimillian-Universität München, Neurologische Klinik und Poliklinik
    • Mr.  Dr.  Roman  Schniepp 
    • Marchioninistr. 15
    • 81337  München
    • Germany
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    • Deutsches Schwindel- und Gleichgewichtszentrum und Neurologische Poliklinik und Klinik der Universität München
    • Mr.  Dr.  Roman  Schniepp 
    • Machioninistr. 15
    • 81377  München
    • Germany
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    • Deutsches Schwindel- und Gleichgewichtszentrum, Klinikum der Universität München
    • Ms.  Kristin  Heßelbarth 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Schwindel- und Gleichgewichtszentrum und Neurologische Poliklinik und Klinik der Universität München; Finanzierung: Ludwigs-Maximilians-Universität München, FöFoLe
    • Mr.  Dr.  Roman  Schniepp 
    • Machioninistr. 15
    • 81377  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.