<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03029312</url>
  </required_header>
  <id_info>
    <org_study_id>11/WM/0275</org_study_id>
    <nct_id>NCT03029312</nct_id>
  </id_info>
  <brief_title>Whole Body Vibration Training in Children With Osteogenesis Imperfecta and Limited Mobility</brief_title>
  <official_title>Whole Body Vibration as an Osteogenic Treatment for Children With Osteogenesis Imperfecta With Limited Mobility: A Randomised Controlled Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Birmingham Women's and Children's NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Manchester Children' s Hospital, Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sheffield</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Birmingham Women's and Children's NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children with osteogenesis imperfecta (OI) have impaired bone strength, fractures, weak&#xD;
      muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may benefit from&#xD;
      muscle training that leads to secondary improvement in bone strength (osteogenic treatment).&#xD;
      Recent studies in children with cerebral palsy but also OI suggest that Whole Body Vibration&#xD;
      Training (WBVT) improves mobility and also bone strength. No randomized controlled trials&#xD;
      exist in OI children. This randomized controlled pilot study assesses the effect of 5 months&#xD;
      WBVT (2 x 9min/day) on muscle function, mobility, bone structure and density. 24 children &gt;5&#xD;
      years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into a&#xD;
      WBVT group and a control group matched by gender and pubertal stage. Main outcome measure is&#xD;
      the change in tibial volumetric BMD, secondary outcomes include a variety of bone, mobility&#xD;
      and dynamic muscle function variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteogenesis imperfecta (OI) is a bone fragility disorder with impaired bone strength,&#xD;
      fractures, weak muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may&#xD;
      not require bisphosphonate therapy but would benefit from muscle training that leads to&#xD;
      secondary improvement in bone strength (osteogenic treatment). The mechanostat theory states&#xD;
      that bone adapts its strength to mechanical forces mostly imposed by muscle. According to&#xD;
      this widely accepted theory, any treatment that strengthens muscle should also strengthen&#xD;
      bones. Whole body vibration therapy (WBVT) with side-alternating platforms (Galileo™) uses&#xD;
      the body's neuromotor reflex system to train muscles. Recent studies in children with&#xD;
      cerebral palsy but also OI suggest that WBVT improves mobility and also bone strength. No&#xD;
      randomized controlled trials exist in OI children.&#xD;
&#xD;
      This randomized controlled study assesses the effect of 5 months whole body vibration&#xD;
      training (2 x 9min/day) on muscle strength, motor function, bone structure and density. 24&#xD;
      children &gt;5 years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be&#xD;
      randomized into a WBVT group and a control group matched by gender and pubertal stage.&#xD;
      Children with OI will be recruited from specialist clinics in Birmingham, Manchester and&#xD;
      Sheffield, as well as via advertisement on the Brittle Bone Society's homepage. Patients will&#xD;
      be equipped with side-alternating vibration platforms for home use and train with increasing&#xD;
      intensity. Outcome measures are tested pre- and post 5-months intervention. Dynamic muscle&#xD;
      function is measured by mechanography (jumping force plates) and mobility by CHAQ&#xD;
      questionnaire and a six-minute walk test. Changes in bone structure and density are assessed&#xD;
      by DXA and peripheral QCT of the tibia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2012</start_date>
  <completion_date type="Actual">January 18, 2016</completion_date>
  <primary_completion_date type="Actual">November 18, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Paired randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Does WBVT increase bone density at the distal tibia</measure>
    <time_frame>5 months</time_frame>
    <description>Trabecular volumetric BMD measured at the distal tibia (4% of tibia length)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Does WBVT result in an increase in dynamic muscle function</measure>
    <time_frame>5 months</time_frame>
    <description>Jumping Mechanography (single 2-leg jump, multiple one leg hop, chair and heel rise test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does WBVT result in an increase in muscle mass</measure>
    <time_frame>5 months</time_frame>
    <description>Muscle mass measured by DXA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does WBVT result in an increase in density</measure>
    <time_frame>5 months</time_frame>
    <description>Bone density measured by DXA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does WBVT result in an increase in density of the tibia</measure>
    <time_frame>5 months</time_frame>
    <description>Bone density measured by pQCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does WBVT result in an increase in bone geometry</measure>
    <time_frame>5 months</time_frame>
    <description>Bone size measured by pQCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does WBVT result in an increase in 6-minute walking distance</measure>
    <time_frame>5 months</time_frame>
    <description>six minute walk tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does WBVT result in improved disability</measure>
    <time_frame>5 months</time_frame>
    <description>CHAQ disability score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does WBVT result in improved balance</measure>
    <time_frame>5 months</time_frame>
    <description>Balance (sway area measured by mechanography)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Osteogenesis Imperfecta</condition>
  <arm_group>
    <arm_group_label>Whole Body Vibration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular Care, including physiotherapy for 5 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Galileo M</intervention_name>
    <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.</description>
    <arm_group_label>Whole Body Vibration</arm_group_label>
    <other_name>Vibraflex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with mild OI (type 1 and 4; &gt;5y of age) who need to be at least partly ambulant&#xD;
        and have a CHAQ score of greater than 0.13, constituting at least mild disability. Minimum&#xD;
        requirement is the ability to rise from a chair.&#xD;
&#xD;
        Informed consent is required from the participant and/or parent/guardian.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On bisphosphonate treatment for less than 2years (since mobility usually improves&#xD;
             during the initial phase treatment).&#xD;
&#xD;
          -  Finished bisphosphonate therapy less than 6 months ago&#xD;
&#xD;
          -  Recent lower limb fracture &lt;3months ago, or upper limb fracture which is still in&#xD;
             plaster.&#xD;
&#xD;
          -  Heart or lung disease, use of steroids (oral, systemic, topical or inhaled, for more&#xD;
             than 3 weeks in the last 12 months) or any other bone-active treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>12 boys, 12 girls</gender_description>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wolfgang Högler, MD PD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Birmingham Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham Children's Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B46NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>whole body vibration</keyword>
  <keyword>Muscle function</keyword>
  <keyword>Physical activity</keyword>
  <keyword>bone density</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteogenesis Imperfecta</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymised data available on request, subject to Ethical and R&amp;D guidelines</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03029312
org study id: 11/WM/0275
nct id: NCT03029312
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Paired randomized controlled study
primary purpose: Treatment
masking: None (Open Label)
measure: Does WBVT increase bone density at the distal tibia
time frame: 5 months
description: Trabecular volumetric BMD measured at the distal tibia (4% of tibia length)
measure: Does WBVT result in an increase in dynamic muscle function
time frame: 5 months
description: Jumping Mechanography (single 2-leg jump, multiple one leg hop, chair and heel rise test)
measure: Does WBVT result in an increase in muscle mass
time frame: 5 months
description: Muscle mass measured by DXA
measure: Does WBVT result in an increase in density
time frame: 5 months
description: Bone density measured by DXA
measure: Does WBVT result in an increase in density of the tibia
time frame: 5 months
description: Bone density measured by pQCT
measure: Does WBVT result in an increase in bone geometry
time frame: 5 months
description: Bone size measured by pQCT
measure: Does WBVT result in an increase in 6-minute walking distance
time frame: 5 months
description: six minute walk tests
measure: Does WBVT result in improved disability
time frame: 5 months
description: CHAQ disability score
measure: Does WBVT result in improved balance
time frame: 5 months
description: Balance (sway area measured by mechanography)
arm group label: Whole Body Vibration
arm group type: Experimental
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 group label: Regular Care
arm group type: No Intervention
description: Regular Care, including physiotherapy for 5 months
intervention type: Device
intervention name: Galileo M
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.
arm group label: Whole Body Vibration
other name: Vibraflex
criteria: 
gender: All
gender based: Yes
gender description: 12 boys, 12 girls
minimum age: 5 Years
maximum age: 16 Years
healthy volunteers: No
last name: Wolfgang Högler, MD PD
role: Principal Investigator
affiliation: Birmingham Children's Hospital
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Osteogenesis Imperfecta
sharing ipd: Yes
ipd description: Anonymised data available on request, subject to Ethical and R&D guidelines