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

Osteogenesis Imperfecta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029312
• Other study ID #: 11/WM/0275
• Status: Completed
• Phase: N/A
• First received: January 19, 2017
• Last updated: January 23, 2017
• Start date: January 17, 2012
• Est. completion date: January 18, 2016

Study information

• Verified date: January 2017
• Source: Birmingham Children's Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 18, 2016
• Est. primary completion date: November 18, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Birmingham Children's Hospital	Birmingham

Sponsors (3)

Lead Sponsor	Collaborator
Birmingham Children's Hospital NHS Foundation Trust	Royal Manchester Children' s Hospital, Manchester, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does WBVT increase bone density at the distal tibia	Trabecular volumetric BMD measured at the distal tibia (4% of tibia length)	5 months
Secondary	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)	5 months
Secondary	Does WBVT result in an increase in muscle mass	Muscle mass measured by DXA	5 months
Secondary	Does WBVT result in an increase in density	Bone density measured by DXA	5 months
Secondary	Does WBVT result in an increase in density of the tibia	Bone density measured by pQCT	5 months
Secondary	Does WBVT result in an increase in bone geometry	Bone size measured by pQCT	5 months
Secondary	Does WBVT result in an increase in 6-minute walking distance	six minute walk tests	5 months
Secondary	Does WBVT result in improved disability	CHAQ disability score	5 months
Secondary	Does WBVT result in improved balance	Balance (sway area measured by mechanography)	5 months