xml: <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/NCT06010134</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/002577</org_study_id>
      <nct_id>NCT06010134</nct_id>
    </id_info>
    <brief_title>Osteogenesis Imperfecta and Balance</brief_title>
    <official_title>Efficacy of Whole Body Vibration on Balance and Motor Control in Children With Osteogenesis Imperfecta</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>South Valley University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>South Valley University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Osteogenesis Imperfecta (OI), also known as brittle bone disease, is a group of genetic&#xD;
        disorders that mainly affect the bones. It results in bones that break easily. Its severity&#xD;
        may be mild to severe. Other symptoms may include a blue tinge to the whites of the eye,&#xD;
        short height, loose joints, hearing loss, breathing problems and problems with the teeth.&#xD;
  &#xD;
        Physiotherapy is aimed to strengthen muscles and improve motility in a gentle manner, while&#xD;
        minimizing the risk of fracture, and the use of support cushions to improve posture.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aimed to assess the efficacy of Whole Body Vibration on balance and motor function&#xD;
        in children with Osteogenesis Imperfecta.&#xD;
  &#xD;
        Whole body vibration (WBV) therapy is targeted at musculoskeletal strengthening and has been&#xD;
        trialed in a variety of conditions. WBV has been shown to have therapeutic advantage in&#xD;
        various osteopenic preclinical models and populations such as postmenopausal women (improved&#xD;
        mobility, muscle strength, postural strength, and bone density) and children with&#xD;
        osteogenesis imperfecta (improved mobility)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>G 1 (control) received traditional physical therapy program for 30 min. G 2 (study) received traditional physical therapy program for 15 min. and Whole Body Vibration for 15 min</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Double (Participant, Investigator) Single (Outcomes Assessor) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group 1 (control group) and Group 2 (Whole Body Vibration group).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Over All Stabiity Index</measure>
      <time_frame>at day 0</time_frame>
      <description>Stability Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Over All Stabiity Index</measure>
      <time_frame>at day 90</time_frame>
      <description>Stability Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Medio lateral Stabiity Index</measure>
      <time_frame>at day 0</time_frame>
      <description>Stability Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Medio lateral Stabiity Index</measure>
      <time_frame>at day 90</time_frame>
      <description>Stability Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antro posterior Stabiity Index</measure>
      <time_frame>at day 0</time_frame>
      <description>Stabiity Index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antro posterior Stabiity Index</measure>
      <time_frame>at day 90</time_frame>
      <description>Stabiity Index</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Osteogenesis Imperfecta</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand pronator, wrist extensors, knee extensors and ankle dorsiflexors, coordination and balancing exercises.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 2 the study group received the same physical therapy program 15 min. plus Whole Body Vibration for 15 min.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physical Therapy Program</intervention_name>
      <description>Physical Therapy Program plus Whole Body Vibration</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Their age was ranging from six to twelve years&#xD;
  &#xD;
            2. Children participated in this study were from both sexes&#xD;
  &#xD;
            3. All children with stable medical and psychological status.&#xD;
  &#xD;
            4. They were able to follow the verbal commands or instructions during testing.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Children with visual or auditory problems.&#xD;
  &#xD;
            2. Children with any cognitive problems.&#xD;
  &#xD;
            3. Children without deformity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hanady Mohamed</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Physical Therapy, Benha University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nehad Abo-zaid, Assistant Professor</last_name>
      <phone>+201008980727</phone>
      <email>dr.nehadahmed@svu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>South Valley University, Faculty of Physical Therapy</name>
        <address>
          <city>Qina</city>
          <zip>83523</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <results_reference>
      <citation>Andersen PE Jr, Hauge M. Osteogenesis imperfecta: a genetic, radiological, and epidemiological study. Clin Genet. 1989 Oct;36(4):250-5. doi: 10.1111/j.1399-0004.1989.tb03198.x.</citation>
      <PMID>2805382</PMID>
    </results_reference>
    <results_reference>
      <citation>Folkestad L, Hald JD, Ersboll AK, Gram J, Hermann AP, Langdahl B, Abrahamsen B, Brixen K. Fracture Rates and Fracture Sites in Patients With Osteogenesis Imperfecta: A Nationwide Register-Based Cohort Study. J Bone Miner Res. 2017 Jan;32(1):125-134. doi: 10.1002/jbmr.2920. Epub 2016 Aug 29.</citation>
      <PMID>27448250</PMID>
    </results_reference>
    <results_reference>
      <citation>Bishop N. Bone Material Properties in Osteogenesis Imperfecta. J Bone Miner Res. 2016 Apr;31(4):699-708. doi: 10.1002/jbmr.2835. Epub 2016 Mar 26.</citation>
      <PMID>26987995</PMID>
    </results_reference>
    <results_reference>
      <citation>Rauch F, Travers R, Parfitt AM, Glorieux FH. Static and dynamic bone histomorphometry in children with osteogenesis imperfecta. Bone. 2000 Jun;26(6):581-9. doi: 10.1016/s8756-3282(00)00269-6.</citation>
      <PMID>10831929</PMID>
    </results_reference>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>South Valley University</investigator_affiliation>
      <investigator_full_name>Nehad Ahmed Youness Abo-zaid</investigator_full_name>
      <investigator_title>Assistant Professor of Pediatric Physical Therapy</investigator_title>
    </responsible_party>
    <keyword>Osteogenesis Imperfecta</keyword>
    <keyword>Whole Body Vibration</keyword>
    <keyword>Balance</keyword>
    <keyword>Motor Control</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010134
  org study id: P.T.REC/012/002577
  nct id: NCT06010134
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Osteogenesis Imperfecta (OI), also known as brittle bone disease, is a group of genetic
        disorders that mainly affect the bones. It results in bones that break easily. Its severity
        may be mild to severe. Other symptoms may include a blue tinge to the whites of the eye,
        short height, loose joints, hearing loss, breathing problems and problems with the teeth.
  
        Physiotherapy is aimed to strengthen muscles and improve motility in a gentle manner, while
        minimizing the risk of fracture, and the use of support cushions to improve posture.
  This study aimed to assess the efficacy of Whole Body Vibration on balance and motor function
        in children with Osteogenesis Imperfecta.
  
        Whole body vibration (WBV) therapy is targeted at musculoskeletal strengthening and has been
        trialed in a variety of conditions. WBV has been shown to have therapeutic advantage in
        various osteopenic preclinical models and populations such as postmenopausal women (improved
        mobility, muscle strength, postural strength, and bone density) and children with
        osteogenesis imperfecta (improved mobility)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: G 1 (control) received traditional physical therapy program for 30 min. G 2 (study) received traditional physical therapy program for 15 min. and Whole Body Vibration for 15 min
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Double (Participant, Investigator) Single (Outcomes Assessor) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group 1 (control group) and Group 2 (Whole Body Vibration group).
  measure: Over All Stabiity Index
  time frame: at day 0
  description: Stability Index
  measure: Over All Stabiity Index
  time frame: at day 90
  description: Stability Index
  measure: Medio lateral Stabiity Index
  time frame: at day 0
  description: Stability Index
  measure: Medio lateral Stabiity Index
  time frame: at day 90
  description: Stability Index
  measure: Antro posterior Stabiity Index
  time frame: at day 0
  description: Stabiity Index
  measure: Antro posterior Stabiity Index
  time frame: at day 90
  description: Stabiity Index
  arm group label: Control Group
  arm group type: Experimental
  description: Group 1 the control group received selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand pronator, wrist extensors, knee extensors and ankle dorsiflexors, coordination and balancing exercises.
  arm group label: Study group
  arm group type: Experimental
  description: Group 2 the study group received the same physical therapy program 15 min. plus Whole Body Vibration for 15 min.
  intervention type: Other
  intervention name: Physical Therapy Program
  description: Physical Therapy Program plus Whole Body Vibration
  arm group label: Control Group
  arm group label: Study group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Hanady Mohamed
  role: Principal Investigator
  affiliation: Faculty of Physical Therapy, Benha University
  last name: Nehad Abo-zaid, Assistant Professor
  phone: +201008980727
  email: dr.nehadahmed@svu.edu.eg
  facility: 
  status: Recruiting
  country: Egypt
  citation: Andersen PE Jr, Hauge M. Osteogenesis imperfecta: a genetic, radiological, and epidemiological study. Clin Genet. 1989 Oct;36(4):250-5. doi: 10.1111/j.1399-0004.1989.tb03198.x.
  PMID: 2805382
  citation: Folkestad L, Hald JD, Ersboll AK, Gram J, Hermann AP, Langdahl B, Abrahamsen B, Brixen K. Fracture Rates and Fracture Sites in Patients With Osteogenesis Imperfecta: A Nationwide Register-Based Cohort Study. J Bone Miner Res. 2017 Jan;32(1):125-134. doi: 10.1002/jbmr.2920. Epub 2016 Aug 29.
  PMID: 27448250
  citation: Bishop N. Bone Material Properties in Osteogenesis Imperfecta. J Bone Miner Res. 2016 Apr;31(4):699-708. doi: 10.1002/jbmr.2835. Epub 2016 Mar 26.
  PMID: 26987995
  citation: Rauch F, Travers R, Parfitt AM, Glorieux FH. Static and dynamic bone histomorphometry in children with osteogenesis imperfecta. Bone. 2000 Jun;26(6):581-9. doi: 10.1016/s8756-3282(00)00269-6.
  PMID: 10831929
  responsible party type: Principal Investigator
  investigator affiliation: South Valley University
  investigator full name: Nehad Ahmed Youness Abo-zaid
  investigator title: Assistant Professor of Pediatric Physical Therapy
  mesh term: Osteogenesis Imperfecta
  sharing ipd: No