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

Primary Purpose

Osteogenesis Imperfecta

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Galileo M
Sponsored by
Birmingham Women's and Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteogenesis Imperfecta focused on measuring whole body vibration, Muscle function, Physical activity, bone density

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Whole Body Vibration

Regular Care

Arm Description

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.

Regular Care, including physiotherapy for 5 months

Outcomes

Primary Outcome Measures

Does WBVT increase bone density at the distal tibia
Trabecular volumetric BMD measured at the distal tibia (4% of tibia length)

Secondary Outcome Measures

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)
Does WBVT result in an increase in muscle mass
Muscle mass measured by DXA
Does WBVT result in an increase in density
Bone density measured by DXA
Does WBVT result in an increase in density of the tibia
Bone density measured by pQCT
Does WBVT result in an increase in bone geometry
Bone size measured by pQCT
Does WBVT result in an increase in 6-minute walking distance
six minute walk tests
Does WBVT result in improved disability
CHAQ disability score
Does WBVT result in improved balance
Balance (sway area measured by mechanography)

Full Information

First Posted
January 19, 2017
Last Updated
January 23, 2017
Sponsor
Birmingham Women's and Children's NHS Foundation Trust
Collaborators
Royal Manchester Children' s Hospital, Manchester, University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT03029312
Brief Title
Whole Body Vibration Training in Children With Osteogenesis Imperfecta and Limited Mobility
Official Title
Whole Body Vibration as an Osteogenic Treatment for Children With Osteogenesis Imperfecta With Limited Mobility: A Randomised Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 17, 2012 (Actual)
Primary Completion Date
November 18, 2015 (Actual)
Study Completion Date
January 18, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Birmingham Women's and Children's NHS Foundation Trust
Collaborators
Royal Manchester Children' s Hospital, Manchester, University of Sheffield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta
Keywords
whole body vibration, Muscle function, Physical activity, bone density

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Paired randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole Body Vibration
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular Care
Arm Type
No Intervention
Arm Description
Regular Care, including physiotherapy for 5 months
Intervention Type
Device
Intervention Name(s)
Galileo M
Other Intervention Name(s)
Vibraflex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Does WBVT increase bone density at the distal tibia
Description
Trabecular volumetric BMD measured at the distal tibia (4% of tibia length)
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Does WBVT result in an increase in dynamic muscle function
Description
Jumping Mechanography (single 2-leg jump, multiple one leg hop, chair and heel rise test)
Time Frame
5 months
Title
Does WBVT result in an increase in muscle mass
Description
Muscle mass measured by DXA
Time Frame
5 months
Title
Does WBVT result in an increase in density
Description
Bone density measured by DXA
Time Frame
5 months
Title
Does WBVT result in an increase in density of the tibia
Description
Bone density measured by pQCT
Time Frame
5 months
Title
Does WBVT result in an increase in bone geometry
Description
Bone size measured by pQCT
Time Frame
5 months
Title
Does WBVT result in an increase in 6-minute walking distance
Description
six minute walk tests
Time Frame
5 months
Title
Does WBVT result in improved disability
Description
CHAQ disability score
Time Frame
5 months
Title
Does WBVT result in improved balance
Description
Balance (sway area measured by mechanography)
Time Frame
5 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
12 boys, 12 girls
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Högler, MD PD
Organizational Affiliation
Birmingham Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Children's Hospital
City
Birmingham
ZIP/Postal Code
B46NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised data available on request, subject to Ethical and R&D guidelines
Citations:
PubMed Identifier
28472303
Citation
Hogler W, Scott J, Bishop N, Arundel P, Nightingale P, Mughal MZ, Padidela R, Shaw N, Crabtree N. The Effect of Whole Body Vibration Training on Bone and Muscle Function in Children With Osteogenesis Imperfecta. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2734-2743. doi: 10.1210/jc.2017-00275.
Results Reference
derived

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

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