Trial document




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  DRKS00006253

Trial Description

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Title

Gait and stance stability in cancer patients before and after rehabilitation

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Trial Acronym

Go-Pilot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Cancer patients undergoing intensive therapies suffer from a decline of physical performance, reduced mobility, gait- and stance instabilities
and limitations of their daily activities. Gait analysis have not been established in oncological settings so far. Therefore, this study analyses gait stability of patients after allogeneic haematopoietic cell transplantation (alloHCT) and/or with multiple myeloma and will take place at the beginning and at the end of the rehabilitation stay in the clinic of tumorbiology Freiburg. Data will be compared to healthy controls. The aim of the study is to evaluate the effects of rehabilitation and provide reference values of gait stability in patients after intensive chemotherapy compared to healthy controls.

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Brief Summary in Scientific Language

Intensive chemo-therapies through to alloHCT lead to a reduced physical performance and postural stability. Patients suffer from instability of gait and stance, reduced mobility and limitations of their daily activities. Gait parameters are common used to assess frailty and mobility, but have not been established in oncological settings so far. Therefore, this study analyses gait stability of patients after alloHCT and/or with multiple myeloma and will take place at the beginning and at the end of their rehabilitation stay in the clinic of tumorbiology Freiburg. Data will be compared to matched healthy controls. The aim of this pilot study is to evaluate the effects of rehabilitation and provide reference values of gait stability in patients after intensive chemotherapy compared to healthy controls.

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Organizational Data

  •   DRKS00006253
  •   2014/07/09
  •   [---]*
  •   yes
  •   Approved
  •   102/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   [---]* 
  •   [---]* 
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Health Condition or Problem studied

  •   C81-C96 -  Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Dynamic postural control of patients after alloHCT or with Multiple Myeloma will be observed during their rehabilitation stay. The study-specific measurements include gait analysis and will be performed at the beginning and at the end of stay. There will be no intervention besides standard rehabilitation program.
    This observation is a preliminary study of DRKS00003492 to prove the method of gait analyses. The amendment has been approved by the responsible ethics committee: 102/12_140596
  •   healthy matched controls, only one crosssectional measurement comparing to patients group, no intervention
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Screening
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

gait stability (sec., m/s, Coefficient of variation%)

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Secondary Outcome

a - Questionnaire regarding side effects (score)
b - Duration of hospitalization (days)
c - Overall duration of the medical treatment after initial diagnosis (weeks)
d - Questionnaire of activity behaviour before and since initial diagnosis (Score)
e - Falls Efficacy Scale-International Version (FES-I) (Score)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/08/01
  •   60
  •   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

patients after allogeneic stem cell transplantation
patients with multiple myeloma
Participation at the rehabilitation at the clinic of tumorbiology Freiburg
Written informed consent of the patient

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Exclusion Criteria

no written informed consent

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Addresses

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    • Universtätsklinik FreiburgKlinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Prof. Dr.  Hartmut  Bertz 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universität Freiburg Institut für Sport und Sportwissenschaft
    • Mr.  Professor  Albert  Gollhofer 
    • Schwarzwaldstr. 175
    • 79117  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinikum Freiburg, Department Innere Medizin, Institut für Bewegungs- und Arbeitsmedizin
    • Ms.  Anja  Wehrle 
    • Hugstetterstr. 55
    • 79106  Freiburg. i. Br.
    • Germany
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    • Klinik für Tumorbiologie
    • Mr.  Dr.  Andreas  Mumm 
    • Freiburg i. Br.
    • Germany
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    • Universtätsklinik FreiburgKlinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Sarah  Kneis 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik Freiburg Klinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Prof. Dr.  Hartmut  Bertz 
    • Hämatologie/Onkologie Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/28
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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.