Trial document





This trial has been registered retrospectively.
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  DRKS00004676

Trial Description

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Title

Assessment of H-Reflexes in patients with hematological/oncological diseases and peripheral polyneuropathy.

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Trial Acronym

no acronym

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Neurotoxic side effects of chemo-therapy can lead to sensory and motory disorders manifesting as polyneuropathy (PNP) and resulting in balanace and gait problems. In a still unpublished study "Effects of a training intervention on polyneuropathic symptoms in patients with hematological/oncological diseases - PNP-pilot-study" we found that cancer patients with polyneuropathy differ from healthy controls in their static and dynamic balance and improved their balance performance after a trainings intervention. Besides impairments of sensibility and muscular activation, changes in motor control are thought to contribute to impaired balance control in polyneuropathy. Thereby, reflex regulation plays a major part. To gain more information about reflex regulation in polyneuropathy, H-reflexes in different balance tasks will be examined. At the same time, balance performance will be measured and polyneuropthy will be assesed using clinical tests and questionaires. There already exist a number of studies investigating reflex regulation among healthy subjects and its contribution to balance performance. However, in polyneuropathy this has not been studied so far.

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Brief Summary in Scientific Language

In this controled cross-sectional study, regulation of H-reflexes under different balance conditions in cancer patients with polyneuropthy (PNP) will be investigated to generate a better understanding for the underlying mechanisms of PNP regadring motor control. Therefor cancer patients with symptoms of polyneuropathy and an age, height and weight-matched control group will be recruited. Tests will contain H-reflex meassurements, a balance test, as wll as clinical neurological tests and a questionnaire about subjective PNP-symptoms (FACT/GOG-Ntx) classifying PNP.

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Organizational Data

  •   DRKS00004676
  •   2013/02/04
  •   [---]*
  •   yes
  •   Approved
  •   478/11_120946, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   C00-C97 -  Malignant neoplasms
  •   G60-G64 -  Polyneuropathies and other disorders of the peripheral nervous system
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Interventions/Observational Groups

  •   Evaluation of H-reflex regulation and postural control under different balance conditions in cancer patients with PNP symptoms
  •   age matched, healthy control group
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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

crosssectional electrophysiological examination of H-reflex regulation (H/M ratio)

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Secondary Outcome

Sway area of center of pressure (COP) on a force plate, clinical postural stability (Balance Test), subjektive evaluatuion of PNP-symptoms (Questionnaire FACT/GOG-Ntx), deep sensibility (tuning fork). All measurements in the same session.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/12/04
  •   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: hematological/oncological disease and symptoms of plyneuropathy - signed informed consent.
Controls: age/weight/height equal as patients - signed informed consent.

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Exclusion Criteria

Contorls: Polyneuropathy

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Addresses

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    • UNIVERSITÄTSKLINIKUM FREIBURGKlinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg Neurozentrum
    • Mr.  PD Dr.  Christioph  Maurer 
    • Breisacherstr. 64
    • 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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    • Klinik für Tumorbiologie
    • Mr.  Dr.  Bernd  Hildenbrand 
    • Freiburg i. Br.
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURGKlinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Sarah  Kneis 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURGKlinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Sarah  Kneis 
    • Hugstetterstr.55
    • 79117  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • UNIVERSITÄTSKLINIKUM FREIBURGKlinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Professor  Hartmut  Bertz 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    end of 1:1-Block address contact materialSupport
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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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Status

  •   Recruiting complete, follow-up complete
  •   2013/10/27
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* This entry means the parameter is not applicable or has not been set.