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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03029312
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
Sponsor:
Collaborators:
Royal Manchester Children' s Hospital, Manchester
University of Sheffield
Information provided by (Responsible Party):
Birmingham Women's and Children's NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Osteogenesis Imperfecta Device: Galileo M Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Paired randomized controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   12 boys, 12 girls
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom, B46NH
Sponsors and Collaborators
Birmingham Women's and Children's NHS Foundation Trust
Royal Manchester Children' s Hospital, Manchester
University of Sheffield
Investigators
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Principal Investigator: Wolfgang Högler, MD PD Birmingham Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Birmingham Women's and Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03029312    
Other Study ID Numbers: 11/WM/0275
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data available on request, subject to Ethical and R&D guidelines

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Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Birmingham Women's and Children's NHS Foundation Trust:
whole body vibration
Muscle function
Physical activity
bone density
Additional relevant MeSH terms:
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Osteogenesis Imperfecta
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases