Trial document





This trial has been registered retrospectively.
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  DRKS00011876

Trial Description

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Title

Effects of a combined cognitive and motor training on motor rehabilitation outcome after stroke

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In a clinical trail with a training and a control group it should be examined if a combined cognitive and physical training approach improves early rehabilitation outcome in patients suffering from stroke.

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Brief Summary in Scientific Language

Stroke is the main cause of acquired, persisting disability in adulthood. Besides motor impairments, cognitive dysfunction are common sequelae after stroke. Even though the negative impact of cognitive impairment on motor recovery is well known, motor function and cognition are still not considered as dependent entities. To be successful, rehabilitation, as a process of relearning, requires cognitive resources, implicating a relationship worth to consider in conception of treatments. It is therefore the aim of the study to evaluate the effects of a combined cognitive and motor training on the functional outcome in the early rehabilitation phase after stroke compared to an approach not specifically considering cognition.

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Organizational Data

  •   DRKS00011876
  •   2018/06/07
  •   [---]*
  •   yes
  •   Approved
  •   17-075, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   I63 -  Cerebral infarction
  •   I61 -  Intracerebral haemorrhage
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Interventions/Observational Groups

  •   Intervention: combined training of 20 minutes cognitive training with NEUROvitalis HOME + 45 minutes of Motor therapy (physical/ occupational therapy)
  •   Control: combined training of 20 minutes low-frequency ergometer training (passive/ active) + 45 minutes Motor therapy (physical/ occupational therapy)
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   I-II
  •   N/A
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Primary Outcome

Cognition:
General cognition and subfunctions (DemTect), processing speed, cognitive flexibility and exekutiv functionen (Trail Making Test A and B, TMTB/A), attention (Test of Attentional Performance, TAP-M, subtest alertness), reaction control (Test of Attentional Performance, TAP-M, subtest Inhibition)
Motor function:
bed mobility (Trunk Control Test), Balance (Berg Balance Scale), Hand function (Fist Closure Frequency)
Functioning:
ADL function (Functional Independence Measure), neurological status (National Institute of Health Stroke Scale)
Timepoints:
baseline (1 day prior to start of training)
post training (1 day after end of training)

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Secondary Outcome

Age, gender, education, Vision, Hearing, time since onset of stroke, type of stroke, hemisphere and Region aphasia, neglect, mood, Level of activity before stroke, orientation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/05/08
  •   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

first ever stroke; maximum 7 days since stroke onset; no additional, relevant neurological or psychiatric disease; able to follow therapeutic instructions; able to understand and give informed consent

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Exclusion Criteria

severe aphasia; severe vigilance reduction

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Addresses

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    • Klinik und Poliklinik für Neurologie
    • Mr.  PD Dr med  Ozgür  Onur 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln, Medizinische Psychologie
    • Ms.  Mareike  Gooßes 
    • Kerpener Str. 68
    • 50937  Köln
    • Germany
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    • Uniklinik Köln, Medizinische Psychologie
    • Ms.  Mareike  Gooßes 
    • Kerpener Str. 68
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Studienförderungsfonds Universität zu Köln, Verwaltung
    • Universitätsstr. 22a
    • 50937  Köln
    • Germany
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    •   +492214707141
    •   [---]*
    •   [---]*
    •   [---]*
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    • Klinik und Poliklinik für Neurologie
    • Mr.  PD Dr med  Ozgür  Onur 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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