Trial document




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  DRKS00006231

Trial Description

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Title

Cross-cultural adaption and psychometric analysis of the De Morton Mobility Index (DEMMI) and the Hierarchical Assessment of Balance and Mobility (HABAM) in acute-medical geriatric inpatients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The De Morton Mobility Index (DEMMI) and the Hierarchical Assessment of Balance and Mobility (HABAM) are measures of geriatric patients' mobility. The original english versions of these assessments have excellent clinimetric properties.

The DEMMI's cross-cultural adaption in Germany has already been performed, but there has been no clinimetric evaluation in the acute-medical geriatric setting of the German DEMMI version. There has been no cross-cultural adaption of the HABAM in Germany jet.

The aim of this study is to examine validity, reliability, responsivness to change and interpretability of the DEMMI's and the HABAM's German versions in acute-medical geriatric inpatients.

Potential participants for this trial are older acute-medical inpatients.

The hypothesis of this study is: Both outcome measures (DEMMI and HABAM) enable to perform a valid, reliable and responsive measure of mobility in acute-medical geriatric patients.

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Brief Summary in Scientific Language

Clinimetrical trial with examinations of validity, reliability, responsiveness and interpretability.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006231
  •   2014/10/13
  •   [---]*
  •   yes
  •   Approved
  •   2014-05, Ethikkommission des Deutschen Verbandes für Physiotherapie Wremer Specken 4 D-27638 Wremen
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Secondary IDs

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Health Condition or Problem studied

  •   acute-medical geriatric inpatients
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Interventions/Observational Groups

  •   Construct validity: Performance of DEMMI, HABAM and other mobility measures (e.g. Timed Up And Go, Short Physical Performance Battery, Tinetti Test, Functional Ambulation Categories) instantly after admission (within 5 workdays).

    Test-retest reliability: Second performance of the assessments with the same patient conducted by the same rater within a short period of time (max. 1 day).

    Inter-rater reliability: Second performance of the assessment with the same patient conducted by another rater within a short period of time (max. 1 day).

    Responsiveness to change: Performance of the assessments before discharge (at least 10 days and max. 21 days after baseline measure). Additional assessmnet of a "global rating of change".

    Interpretability: Floor- and ceiling effects.

    Unidimensionality: Rasch-Analyis.
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Characteristics

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

Construct validity: Hypothesis-testing of correlations between the index tests (DEMMI and HABAM) and other mesures of mobility (e.g. Timed Up And Go, Short Physical Performance Battery, Tinetti Test, Functional Ambulation Categories).

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Secondary Outcome

1) Test-retest reliability (correlation between 2 test results = Intra-Class Correlation Coefficient [ICC])

2) Inter-rater reliability (correlation between 2 test results = Intra-Class Correlation Coefficient [ICC])

3) Responsiveness: Hypothesis-testing of assumed correlations between change scores of the index tests (DEMMI and HABAM) and the reference tests. Area under the curve (AUC) with respect to the real occurence of change in mobility (yes/no).

4) Interpretability: Floor- and ceiling effects will be reported descriptively.

5) Unidimensionality: Rasch-Analysis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/01
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

(1) Men and women
(2) >59 years of age
(3) inpatient acute-medical care

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Exclusion Criteria

(1) blindness
(2) deafness
(3) severe dysphasia
(4) no written informed consent
(5) diagnosis of dementia or evidence of cognitive impairment (positive Mini-Cog Test)
(6) contraindication for mobilisation
(7) isolated for infection
(8) death imminent
(9) not german speaking
(10) in a state of coma or severe reduction of vigilance
(11) acute severe organ failure
(12) acute severe psychatric condition
(13) all other medical/mental conditions that could lead to a further detoriation of health due to a mobility examination, or that would stress the patients in an unacceptable way.

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Addresses

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    • Hochschule für gesundheit, Bochum
    • Mr.  Prof. Dr.  Christian  Grüneberg 
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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    • Hochschule für Gesundheit
    • Mr.  M.Sc.  Tobias  Braun 
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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    • Hochschule für Gesundheit, Bochum
    • Mr.  M.Sc.  Tobias  Braun 
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Hochschule für Gesundheit
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/04/23
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* This entry means the parameter is not applicable or has not been set.