Trial document





This trial has been registered retrospectively.
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  DRKS00000436

Trial Description

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Title

Practicability and efficacy of training with the Galileo vibration platform in neuromuscular disease

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Trial Acronym

DMD-SMA-Vibra1

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URL of the Trial

[---]*

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Brief Summary in Lay Language

For children with DMD and SMA III is no healing possible.
Different Therapies are available to delay the progress (physiotherapy, medication e.g) in both diseases.
The Galileo Vibration Plate is a medical devise with a CE -Certificate.
In healthy people and sportsmen the Galileo training is a well known training.
Diffrent clinical trials of children with disabilities shows a improved motor function, improved muscle strength and revised structure of bones after training with Galileo.
There are less data available about patients with neuromuscular diseases and training on the Galileo vibration platfrom. The aim of this study is to show the practicability and efficacy of the training with galileo in patients with neuromuscular diseases. We think the training will be helpfull in following points: better muscle function, increased muscle strength, stop of muscle contractures, better metabolism of the bones, advancement quality of life.
The duration of the study is for every patient 3 month. At the beginning is a admission in the hospital for two days due to get instructions for the training.The other visits are ambulant by the PI. In this study 4 blood draws are schedulded

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Brief Summary in Scientific Language

DMD and SMA are progressive diseases.
Duchenne Muscular Dystrophy (DMD) is an x-linked progressive disease affecting about 1 in 3,500 male live births. Although motor milestones can be mildly delayed, the diagnosis is often made around four years of age when proximal muscle weakness becomes more evident. The progressive nature of the disease leads to loss of ambulation in early teens.
Spinal Muscular Atrophy (SMA) is a motor neuron disease. It is a relatively common "rare disorder": approximately 1 in 10000 babies born is affected.
SMA affects muscles throughout the body, although the proximal muscles (those closest to the trunk i.e. shoulders, hips, and back) are often most severely affected. Weakness in the legs is generally greater than in the arms.
Different therapies are available to delay the progress (physiotherapy, medication e.g) in both diseases.We think the training with Galileo will be a useful therapy for improving motor function,delay progress of contactures and revise structure of bones.
There are no data available about patients with neuromuscular diseases and training on the Galileo vibration platfrom.
The aim of this study is to show the practicability and efficacy of the training with galileo in patients with neuromuscular diseases. Trials at health people and patients with ICP shows following improvements: better muscle function, increased muscle strength, stop of muscle contractures, better metabolism of the bones.
The training is training with minimal efforts and can be done at home.

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Organizational Data

  •   DRKS00000436
  •   2011/10/11
  •   [---]*
  •   yes
  •   Approved
  •   228/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   G12.1 -  Other inherited spinal muscular atrophy
  •   G71.0 -  Muscular dystrophy
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Interventions/Observational Groups

  •   Patients with DMD or SMA got a training with the Galileo System. The training will be monitored by lab values and questionnaires
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Characteristics

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

Practicability of training with the Galileo Vibration Platlet in children and adolescent with DMD and SMA III

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Secondary Outcome

Efficacy of the training after 2 month in:
muscle function (improve of 6MWT (=6 Minute Walking Test)measured at baseline and week 8),muscle strengt(measured at baseline and week 8 by MRC Scale =Medical Research Counsil Scale), quality of life(measured at baseline and week 8 by Peds QL= Pediatric Quality of Life), metabolism of bone (measured at baseline and week 8 by blood markers).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/11/06
  •   20
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- boys with diagnosis DMD (approved by gene test or musclebiopsy)
- boys and girls with SMA Type III (approved by gene test )
- age ≥ 5 years and ≤ 18 years
- able to walk 10m without assistance
- able to stand on Galileo apparat
- compliance of the patient
- signed informed consent (parents and patient)

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Exclusion Criteria

. contractures which made the therapy with Galileo impractical
. change of therapy within 3 month prior study
. fracture within 6 month prior study
. acute inflammation of the motoric system
. acute thrombosis within 6 month
. kidney stone, gallstone
. hernia
. acute trauma at feet
. operation within 3 month prior study
. pregnancy
. implants
. seizures

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin
    • Mr.  Dr.med  Janbernd  Kirschner 
    • Mathildenstr.1
    • 79106  Freiburg
    • Germany
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    • Geschäftsstelle Ethikkommission Universität zu Köln Gebäude 5 Kerpener Str. 62 50937 Köln
    • Mr.  Dr. med.  Guido  Grass 
    • Kerpener Str. 62
    • 50937  Köln
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    • Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin
    • Ms.  Dr.med  Julia  Vry 
    • Mathildenstr.1
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin
    • Ms.  Ursula  Wein 
    • Mathildenstr.1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Ministerium für Wissenschaft, Forschung und Kunst Baden Württemberg
    • Mr.    Uwe  Carstens 
    • Königstr. 46
    • 70173  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/11/09
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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.