An interventional study of Galileo M in Osteogenesis Imperfecta, sponsored by Birmingham Women's and Children's NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by Birmingham Women's and Children's NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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.
85 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's enrollment of 24 is close to the median of 26 across 59 interventional studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta studies →Birmingham Women's and Children's NHS Foundation Trust is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
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Patients with mild OI (type 1 and 4; >5y of age) who need to be at least partly ambulant and have a CHAQ score of greater than 0.13, constituting at least mild disability. Minimum requirement is the ability to rise from a chair.
Informed consent is required from the participant and/or parent/guardian.
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Exclusion Criteria:
Twice daily WBVT at home using the Galileo M device, 3x3 min, with 3 minute breaks (total daily WBVT 18 min) for 5 months. Children stand upright on the device, with knees bent (10-45 degrees, semi-squat or squat position). A schedule of increasing intensity of vibration exercise was used over time, allowing some adjustment to the patient's physical capability. Amplitude 1 was used for the first 2 weeks, then increased to amplitude 2 and further increased up to amplitude 3, if individually possible, always using frequencies between 20-25Hz. Children also perform exercises on the platform, including shifting their weight from one side to the other, increase/decrease their knee and hip angle, weight shift with trunk rotation, and alternate flexion and extension of knees.
Device: Galileo M
Regular Care, including physiotherapy for 5 months
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.
Also known as: Vibraflex
Does WBVT increase bone density at the distal tibia
Trabecular volumetric BMD measured at the distal tibia (4% of tibia length)
Time frame: 5 months
Does WBVT result in an increase in dynamic muscle function
Jumping Mechanography (single 2-leg jump, multiple one leg hop, chair and heel rise test)
Time frame: 5 months
Does WBVT result in an increase in muscle mass
Muscle mass measured by DXA
Time frame: 5 months
Does WBVT result in an increase in density
Bone density measured by DXA
Time frame: 5 months
Does WBVT result in an increase in density of the tibia
Bone density measured by pQCT
Time frame: 5 months
Does WBVT result in an increase in bone geometry
Bone size measured by pQCT
Time frame: 5 months
Does WBVT result in an increase in 6-minute walking distance
six minute walk tests
Time frame: 5 months
Does WBVT result in improved disability
CHAQ disability score
Time frame: 5 months
Does WBVT result in improved balance
Balance (sway area measured by mechanography)
Time frame: 5 months
Plan to share: Yes — Anonymised data available on request, subject to Ethical and R\&D guidelines
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Birmingham Women's and Children's NHS Foundation Trust