Trial document




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  DRKS00011331

Trial Description

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Title

Register Muscle-Bone and Children's Rehabilitation

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Trial Acronym

MuKno DB

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The monocentric register "Muscle-Bone Children’s Rehabilitation" has the aim of systematic data collection for quality assurance and continuous therapy optimization.
All patients of the Center for children's rehabilitation of the UniReha GmbH, University Hospital Cologne are included, who have participated in the concept "Auf die Beine" since 2006.
The monocentric register " Muscle-Bone Children’s Rehabilitation " was established in 2009. Since then, the register is kept at the Center for children's rehabilitation of the UniReha GmbH, Clinics of the University of Cologne. So far, data collected in clinical routine (consent within the framework of the integrated supply contracts) were continuously retrospectively evaluated and published. The retrospective analyses showed the need to explore scientific questions of primary care prospectively in future.
For this reason, the current data collection is transferred in a prospective register to examine following questions:
1. Evaluation of the therapeutic effect after taking part in the concept „Auf die Beine“ in subgroups of cerebral palsy by severity and localization of damage.
2. Evaluation of the therapeutic effect in different other diseases, such as spinal muscular atrophy (SMA) and rare diseases.
3. What patient groups will especially benefit from intensive, unit-based physical therapy?
4. The effect of intensity of training? (Parent report on the implementation of the home-based training)
5. Long-term development and sustainability of results.
6. Natural history of various diseases (before start of the concept).
7. Detection of possible side-effects.
8. Demographic data of various clinical pictures.

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Brief Summary in Scientific Language

The monocentric register "Muscle-Bone Children’s Rehabilitation" has the aim of systematic data collection for quality assurance and continuous therapy optimization.

All patients of the Center for children's rehabilitation of the UniReha GmbH, University Hospital Cologne are included, who have participated in the concept "Auf die Beine" since 2006.

The monocentric register " Muscle-Bone Children’s Rehabilitation " was established in 2009. Since then, the register is kept at the Center for children's rehabilitation of the UniReha GmbH, Clinics of the University of Cologne. So far, data collected in clinical routine (consent within the framework of the integrated supply contracts) were continuously retrospectively evaluated and published. The retrospective analyses showed the need to explore scientific questions of primary care prospectively in future.

For this reason, the current data collection is transferred in a prospective register to examine following questions:

1. Evaluation of the therapeutic effect after taking part in the concept „Auf die Beine“ in subgroups of cerebral palsy by severity and localization of damage.

2. Evaluation of the therapeutic effect in different other diseases, such as spinal muscular atrophy (SMA) and rare diseases.

3. What patient groups will especially benefit from intensive, unit-based physical therapy? (Identification responder / Nonresponder)

4. The effect of intensity of training? (Parent report on the implementation of the home-based training)

5. Long-term development and sustainability of results.

6. Natural history of various diseases due to the possibility of capturing cross-sectional data at "M0" (before start of the concept)

7. Detection of possible side-effects.

8. Demographic data of various clinical pictures.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011331
  •   2017/01/19
  •   [---]*
  •   yes
  •   Approved
  •   16-269, 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 -  Cerebral palsy
  •   Q78 -  Other osteochondrodysplasias
  •   Q05 -  Spina bifida
  •   Q76 -  Congenital malformations of spine and bony thorax
  •   G12 -  Spinal muscular atrophy and related syndromes
  •   G82 -  Paraplegia and tetraplegia
  •   F82 -  Specific developmental disorder of motor function
  •   F83 -  Mixed specific developmental disorders
  •   E88 -  Other metabolic disorders
  •   G73 -  Disorders of myoneural junction and muscle in diseases classified elsewhere
  •   Q99 -  Other chromosome abnormalities, not elsewhere classified
  •   R29 -  Other symptoms and signs involving the nervous and musculoskeletal systems
  •   G11 -  Hereditary ataxia
  •   Q04 -  Other congenital malformations of brain
  •   Q87 -  Other specified congenital malformation syndromes affecting multiple systems
  •   R27 -  Other lack of coordination
  •   G81 -  Hemiplegia
  •   G40 -  Epilepsy
  •   P94 -  Disorders of muscle tone of newborn
  •   M41 -  Scoliosis
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Interventions/Observational Groups

  •   Monocentric register of the data of the patients participating in the concept "Auf die Beine"
    of the UniReha GmbH, University Hospital of Cologne.

    Alls patients participating in the concept "Auf die Beine" will be included in the register.

    The concept includes 6 months home-based training with vibration-assisted physiotherapy and 2 short, inpatient stays (two weeks at the beginning and 1 week after 3 months). Goal-oriented, intensive training is performed during the inpatient stays.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

All assessments at the beginning (M0), after 6 months of active training (concept "Auf die Beine") (M6) and 12 months (M12) / 6 months follow-up.

The primary endpoint is the gross motor function measure (GMFM)

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Secondary Outcome

All assessments at the beginning (M0), after 6 months of active training (concept "Auf die Beine") (M6) and 12 months (M12) / 6 months follow-up.

Secondary endpoints include:
joint mobility
Walking distance tests
Training frequency
Main changes of in everyday function
Ground reaction force (jump plate)
Balance
Gait analysis
Bone density measurements (DXA, pqCT)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/02/01
  •   [---]*
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

All patients of the Center for Children's Rehabilitation are included in the monocentric register of UniReha GmbH.

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Exclusion Criteria

All patients, not participating at the concept "Auf the Beine".

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Addresses

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    • Klinik und Poliklinik für Kinder- und JugendmedizinUniversität Köln
    • Mr.  Prof.  Eckhard  Schönau 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Klinisches Studienzentrum Pädiatrie der Universität zu Köln
    • Ms.  Dr.  Barbara  Hero 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    •   221 478 6850
    •   221 478 6851
    •   [---]*
    •   [---]*
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    • Klinik und Poliklinik für Kinder- und Jugendmedizin Universität Köln
    • Ms.  Dr.  Christina  Stark 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Zentrum für Kinderrehabilitation
    • Ms.  Sabine  Möller-Höbing 
    • Lindenburger Allee 44
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Kinder- und JugendmedizinUniversität Köln
    • Mr.  Prof.  Eckhard  Schönau 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Prüfprotokoll
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* This entry means the parameter is not applicable or has not been set.