Skip to main content
OpenTrials
Completed

NCT Number: NCT03029312

Whole Body Vibration Training in Children With Osteogenesis Imperfecta and Limited Mobility

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Children's Hospital

Birmingham, B46NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

-

Exclusion criteria

  • On bisphosphonate treatment for less than 2years (since mobility usually improves during the initial phase treatment).
  • Finished bisphosphonate therapy less than 6 months ago
  • Recent lower limb fracture <3months ago, or upper limb fracture which is still in plaster.
  • Heart or lung disease, use of steroids (oral, systemic, topical or inhaled, for more than 3 weeks in the last 12 months) or any other bone-active treatment.

Treatment and study plan

Galileo M

Device

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 names: Vibraflex

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Does WBVT result in an increase in muscle mass

    Time frame: 5 months

    Muscle mass measured by DXA

  3. Does WBVT result in an increase in density

    Time frame: 5 months

    Bone density measured by DXA

  4. Does WBVT result in an increase in density of the tibia

    Time frame: 5 months

    Bone density measured by pQCT

  5. Does WBVT result in an increase in bone geometry

    Time frame: 5 months

    Bone size measured by pQCT

  6. Does WBVT result in an increase in 6-minute walking distance

    Time frame: 5 months

    six minute walk tests

  7. Does WBVT result in improved disability

    Time frame: 5 months

    CHAQ disability score

  8. Does WBVT result in improved balance

    Time frame: 5 months

    Balance (sway area measured by mechanography)

Sponsors and collaborators

Lead sponsor

Birmingham Women's and Children's NHS Foundation Trust

Other

Collaborators

  • Royal Manchester Children' s Hospital, Manchester
  • University of Sheffield

Registry information

Official study title

Whole Body Vibration as an Osteogenic Treatment for Children With Osteogenesis Imperfecta With Limited Mobility: A Randomised Controlled Pilot Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jan 24, 2017
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.