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

NCT03029312 | Completed

• 1 other identifier: 11/WM/0275
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteogenesis Imperfecta

Keywords

whole body vibration; Muscle function; Physical activity; bone density

Outcome Measures

Primary Outcomes (1)

• Does WBVT increase bone density at the distal tibia

  Trabecular volumetric BMD measured at the distal tibia (4% of tibia length)

  5 months

Secondary Outcomes (8)

• Does WBVT result in an increase in dynamic muscle function

  5 months

• Does WBVT result in an increase in muscle mass

  5 months

• Does WBVT result in an increase in density

  5 months

• Does WBVT result in an increase in density of the tibia

  5 months

• Does WBVT result in an increase in bone geometry

  5 months

Study Arms (2)

Whole Body Vibration

EXPERIMENTAL

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

Regular Care

NO INTERVENTION

Regular Care, including physiotherapy for 5 months

Interventions

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.

Also known as: Vibraflex

Whole Body Vibration

Eligibility Criteria

• Age: 5 Years - 16 Years
• Gender Eligibility Details: 12 boys, 12 girls
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birmingham Women's and Children's NHS Foundation Trust: lead
• Royal Manchester Children' s Hospital, Manchester: collaborator
• University of Sheffield: collaborator

Study Sites (1)

Birmingham Children's Hospital

Birmingham, B46NH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28472303 DERIVED

MeSH Terms

Conditions

Osteogenesis Imperfecta; Motor Activity

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Wolfgang Högler, MD PD

  Birmingham Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Paired randomized controlled study

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 24, 2017
• Study Start: January 17, 2012
• Primary Completion: November 18, 2015
• Study Completion: January 18, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)