Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004163

Trial Description

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Title

Influence of two different concepts for positioning on passive range of motion, comfort and vital parameters in severely affected patients with CNS lesion

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Trial Acronym

LiNvsCON

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URL of the Trial

http://lin-arge.de

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Brief Summary in Lay Language

Positioning is required in patients with lesions in the central nervous system due to prevention of pressure sore, comfort and influence on vital parameters. There is currently little evidence.
In Germany the positioning procedure is quite homogeneous – conventional positioning. In addition there is a newly developed positioning procedure – LiN-Lagerung in Neutralstellung(R) (engl.: positioning in neutral).
Aim of the study is to find out which influence can be found on the above-named parameters. In a multicentre setting severely affected patients, who for example have had a stroke, hypoxia or head trauma, are positioned randomly, allocated to the different positioning procedures. Measurement of passive range of motion, comfort and some vital parameters are taken before and after being positioned for two hours. LiN is considered to be more beneficial .

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Brief Summary in Scientific Language

RCT, multicentre, blinded
200 patients will be enrolled

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Organizational Data

  •   DRKS00004163
  •   2012/06/11
  •   [---]*
  •   yes
  •   Approved
  •   2008-115-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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

  •   I64 -  Stroke, not specified as haemorrhage or infarction
  •   G93.1 -  Anoxic brain damage, not elsewhere classified
  •   G31 -  Other degenerative diseases of nervous system, not elsewhere classified
  •   G35 -  Multiple sclerosis
  •   S06 -  Intracranial injury
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Interventions/Observational Groups

  •   Positioning in LiN-Positioning in Neutral for two hours
  •   Positioning in conventional for two hours
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

difference of degrees of passive range of motion of flexion of the hip joints before and after being positioned for two hours

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Secondary Outcome

difference of degrees of passive range of motion of flexion and external rotation of the shoulder joints,
bloodpressure,
pulse,
breathing frequence
before and after lying for two hours,
comfort measured with a 3-step visual rating scale after lying for hours

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2011/04/04
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

lesion of the central nervous system,
4 and 5 on the rankin scale scored from 0-5

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Exclusion Criteria

contractures
agitated
need of bedrest elevation

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Addresses

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    • St. Mauritius Therapieklinik Bereich Motorik
    • Ms.  Dr. rer. biol. hum.  Heidrun  Pickenbrock 
    • 40670  Meerbusch
    • Germany
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    • St. Mauritius TherapieklinikBereich Motorik
    • Ms.  Dr. rer. biol. hum.  Heidrun  Pickenbrock 
    • Strümper Str. 11
    • 40670  Meerbusch
    • Germany
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    • St. Mauritius TherapieklinikBereich Motorik
    • Ms.  Dr. rer. biol. hum.  Heidrun  Pickenbrock 
    • Strümper Str. 111
    • 40670  Meerbusch
    • Germany
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Sources of Monetary or Material Support

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    • Privat
    • Ms.  MSc  Heidrun  Pickenbrock 
    • Jürgen-Schmeling-Str. 12
    • 45768  Marl
    • Germany
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    • LiN-Arge e. V.
    • Jürgen-Schmeling-Str. 12
    • 45768  Marl
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/09/30
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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.