Whole Body Vibration Training in Children With Osteogenesis Imperfecta and Limited Mobility
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional

Summary: 
      Children with osteogenesis imperfecta (OI) have impaired bone strength, fractures, weak
      muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may benefit from
      muscle training that leads to secondary improvement in bone strength (osteogenic treatment).
      Recent studies in children with cerebral palsy but also OI suggest that Whole Body Vibration
      Training (WBVT) improves mobility and also bone strength. No randomized controlled trials
      exist in OI children. This randomized controlled pilot study assesses the effect of 5 months
      WBVT (2 x 9min/day) on muscle function, mobility, bone structure and density. 24 children >5
      years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into a
      WBVT group and a control group matched by gender and pubertal stage. Main outcome measure is
      the change in tibial volumetric BMD, secondary outcomes include a variety of bone, mobility
      and dynamic muscle function variables.
    

Detailed description: 
      Osteogenesis imperfecta (OI) is a bone fragility disorder with impaired bone strength,
      fractures, weak muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may
      not require bisphosphonate therapy but would benefit from muscle training that leads to
      secondary improvement in bone strength (osteogenic treatment). The mechanostat theory states
      that bone adapts its strength to mechanical forces mostly imposed by muscle. According to
      this widely accepted theory, any treatment that strengthens muscle should also strengthen
      bones. Whole body vibration therapy (WBVT) with side-alternating platforms (Galileo™) uses
      the body's neuromotor reflex system to train muscles. Recent studies in children with
      cerebral palsy but also OI suggest that WBVT improves mobility and also bone strength. No
      randomized controlled trials exist in OI children.

      This randomized controlled study assesses the effect of 5 months whole body vibration
      training (2 x 9min/day) on muscle strength, motor function, bone structure and density. 24
      children >5 years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be
      randomized into a WBVT group and a control group matched by gender and pubertal stage.
      Children with OI will be recruited from specialist clinics in Birmingham, Manchester and
      Sheffield, as well as via advertisement on the Brittle Bone Society's homepage. Patients will
      be equipped with side-alternating vibration platforms for home use and train with increasing
      intensity. Outcome measures are tested pre- and post 5-months intervention. Dynamic muscle
      function is measured by mechanography (jumping force plates) and mobility by CHAQ
      questionnaire and a six-minute walk test. Changes in bone structure and density are assessed
      by DXA and peripheral QCT of the tibia.
    

Intervention name(s): Galileo M
Intervention type(s): Device
Intervention description(s): Motorized board producing side-to-side alternating vertical sinusoidal (rotational) vibrations around a fulcrum in the mid-section of the plate. The vibration frequency can be selected by the user who stands on the board with both feet, wearing shoes. The peak-to-peak displacement to which the feet are exposed increases with the distance of the feet from the centre line of the vibrating board. Three positions marked 1, 2 and 3 are indicated on the vibrating board, corresponding to peak-to-peak displacements of 2, 4, and 6mm. The peak acceleration exerted by vibration exercise increases with higher frequencies and higher amplitudes.
Other intervention name(s): Vibraflex
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Paired randomized controlled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: whole body vibration; Muscle function; Physical activity; bone density