Whole Body Vibration Training in Children With Osteogenesis Imperfecta and Limited Mobility
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|ClinicalTrials.gov Identifier: NCT03029312|
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteogenesis Imperfecta||Device: Galileo M||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Paired randomized controlled study|
|Masking:||None (Open Label)|
|Official Title:||Whole Body Vibration as an Osteogenic Treatment for Children With Osteogenesis Imperfecta With Limited Mobility: A Randomised Controlled Pilot Trial|
|Actual Study Start Date :||January 17, 2012|
|Actual Primary Completion Date :||November 18, 2015|
|Actual Study Completion Date :||January 18, 2016|
Experimental: Whole Body Vibration
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
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 Name: Vibraflex
No Intervention: Regular Care
Regular Care, including physiotherapy for 5 months
- Does WBVT increase bone density at the distal tibia [ Time Frame: 5 months ]Trabecular volumetric BMD measured at the distal tibia (4% of tibia length)
- Does WBVT result in an increase in dynamic muscle function [ Time Frame: 5 months ]Jumping Mechanography (single 2-leg jump, multiple one leg hop, chair and heel rise test)
- Does WBVT result in an increase in muscle mass [ Time Frame: 5 months ]Muscle mass measured by DXA
- Does WBVT result in an increase in density [ Time Frame: 5 months ]Bone density measured by DXA
- Does WBVT result in an increase in density of the tibia [ Time Frame: 5 months ]Bone density measured by pQCT
- Does WBVT result in an increase in bone geometry [ Time Frame: 5 months ]Bone size measured by pQCT
- Does WBVT result in an increase in 6-minute walking distance [ Time Frame: 5 months ]six minute walk tests
- Does WBVT result in improved disability [ Time Frame: 5 months ]CHAQ disability score
- Does WBVT result in improved balance [ Time Frame: 5 months ]Balance (sway area measured by mechanography)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029312
|Birmingham Children's Hospital|
|Birmingham, United Kingdom, B46NH|
|Principal Investigator:||Wolfgang Högler, MD PD||Birmingham Children's Hospital|