Trial document




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  DRKS00010292

Trial Description

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Title

Nutritional Status of children and adolescents with cerebral palsy while participating in "back on your feet"-concept

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Evaluation of nutritional status of children aged 3-18 years by food intake questionaire filled in by the parents during three days before and while participating "back on your feed" concept.

The concept is suited for children and youngsters with limited physical co-ordination and mobility and who are consequently reliant on a wheelchair or Zimmer frames from time to time or permanently. The object of the concept is to improve physical co-ordination and to improve the ability of children and youngsters to stand and walk. In order to achieve these objectives, an attempt is made to improve muscular power, muscular function and muscular co-ordination. At the same time the objective is to decrease existing limitations on joint movement, in particular for the lower extremities. The scheme had been designed to last one year and is divided up into eight stage.

Stage I: Out-patient incoming examination
Stage II: Admission as an in-patient, 13 days
Stage III: 3 months’ training with the "Cologne Galileo standing and walking trainer system" at home Stage
IV: Admission as an in-patient, 6 days
Stage V: 3 months’ training with the "Cologne Galileo standing and walking trainer system" at home
Stage VI: 1st interim examination as an out-patient, 6 months after Stage II, return of the loan equipment " Cologne Galileo standing and walking trainer system" to UniReha for children and youngsters

Stage VIII: Final out-patient examination, 12 months after Stage II

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00010292
  •   2016/04/28
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  •   yes
  •   Approved
  •   16-049, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G80.0 -  Spastic quadriplegic cerebral palsy
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Interventions/Observational Groups

  •   Registration nutritional status of children and adolescents with cerebral palsy by three-days-dietary-intake-protocol by parents before participating "back on your feet"-concept and after three months of training
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of three-days-dietary-intake-protocols referring to calories, carbohydrates, protein and fat before and after three months participating "back-on-your-feet" concept.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/05/02
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   18   Years
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Additional Inclusion Criteria

Chrildren and adolescents
>3 and <18 years
Diagnosis cerebral palsy
Participation "Back on your feet" concept

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Exclusion Criteria

<3 years
>18 years
PEG tube
ketogenic diet
premature termination of "back on your feet" concept

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Addresses

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    • Uniklinik Köln
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • UniReha, Zentrum für Kinderrehabilitation,
    • Ms.  Dr. med.  Evelyn  Alberg 
    • Lindenburger Allee 44
    • 50931  Köln
    • Germany
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    • UniReha, Zentrum für Kinderrehabilitation, Lindenburger Allee 44, 50931 Köln
    • Ms.  Dr. med.  Evelyn  Alberg 
    • Lindenburger Allee 44
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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