<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/NCT03003026</url>
  </required_header>
  <id_info>
    <org_study_id>36209</org_study_id>
    <secondary_id>S16-007</secondary_id>
    <secondary_id>HREC/116/RCHM/16</secondary_id>
    <secondary_id>RES-16-0000555X</secondary_id>
    <nct_id>NCT03003026</nct_id>
  </id_info>
  <brief_title>Bike Skills Training for Children With Cerebral Palsy</brief_title>
  <acronym>CPBIKERCT</acronym>
  <official_title>Bike Skills Training for Children With Cerebral Palsy: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Murdoch Childrens Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Melbourne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Deakin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Monash Medical Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Murdoch Childrens Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An assessor blinded multi-centre randomized controlled trial will be conducted in which 60&#xD;
      participants will be randomized to either a novel task-specific approach to training bike&#xD;
      skills or a parent-led home program comparison group. Baseline assessment will take place&#xD;
      within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within a&#xD;
      week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The&#xD;
      primary outcome is attainment of individualised two-wheel bike specific goals at T1. All&#xD;
      statistical analysis will be conducted on an intention-to-treat basis. Logistic regression&#xD;
      will be used to assess the effect of providing the novel intervention compared to the&#xD;
      parent-led home program on bike-specific goal attainment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">July 21, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Goal attainment at 1 week post the intervention period as measured by the Goal Attainment Scale (GAS)</measure>
    <time_frame>1 week following intervention</time_frame>
    <description>The GAS is a criterion referenced tool for individualized and collaborative goal setting between the child, family and therapist. Two to three individualized goals specific to two-wheel bike riding per participant will be set at the baseline visit with six potential outcomes specified for each goal from (-3 (deterioration), -2 (equal to start), -1 (less than expected), 0 (expected), 1 (somewhat more than expected), 2 (more than expected)). For each goal, attainment is defined as a score of zero or above on the GAS. The primary outcome, goal attainment, will be defined as attainment of at least one goal to an expected (score of zero) or greater level.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Novel task-specific program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention arm - see detailed intervention group description below</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent-led home-based program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comparison arm - see detailed comparison group description below</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Novel task-specific bike skills training program</intervention_name>
    <description>Participants randomised to the intervention group will participate in a novel task-specific bike skills training program. The intervention involves seven key components: it is group-based, intensive (2 hours per day for 3 days plus a home program for the remaining days of the one week period), task-specific, goal-directed, and therapist led, with parent involvement and conducted in an ecological setting. Each program will be run by a physiotherapist and allied health assistant during the school holidays.</description>
    <arm_group_label>Novel task-specific program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parent-led home-based bike skills training program</intervention_name>
    <description>The comparison group will involve a parent-led home-based bike skills training program. Parents of children randomized to the comparison group will receive written information and telephone support from a physiotherapist on training bike skills. They will be encouraged to work with their child towards their bike skills goals for at least 30-45 minutes per day over a one week period during the school holidays in home and community environments.</description>
    <arm_group_label>Parent-led home-based program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Live in Victoria, Australia&#xD;
&#xD;
          -  Diagnosis of cerebral palsy&#xD;
&#xD;
          -  Aged 6 - 15 years&#xD;
&#xD;
          -  Independently ambulant without mobility aids&#xD;
&#xD;
          -  Have goals specific to two-wheel bike skills&#xD;
&#xD;
          -  Have medical clearance to participate&#xD;
&#xD;
          -  Have access to an appropriate bike and helmet&#xD;
&#xD;
          -  Have a primary care giver who understands written and spoken English available to&#xD;
             participate for each participant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a moderate to severe intellectual impairment&#xD;
&#xD;
          -  Has a dual diagnosis with another developmental disability or medical condition that&#xD;
             may impact on their ability or safety to train two-wheel bike skills. This includes;&#xD;
             Autism Spectrum Disorder, Trisomy 21, spina bifida, uncontrolled epilepsy, significant&#xD;
             visual or hearing impairment as determined by medical clearance from the child's&#xD;
             general practitioner or paediatrician&#xD;
&#xD;
          -  Had musculoskeletal surgery, or other major surgery including insertion of a baclofen&#xD;
             pump that may affect their physical ability, in the 6 months prior to randomisation or&#xD;
             during the intervention and 12 week follow up period (if after randomisation, will be&#xD;
             excluded from per-protocol analysis)&#xD;
&#xD;
          -  Has Botulinum toxin-A (BonT-A) injections to the lower limbs and/or upper limbs in the&#xD;
             6 months prior to randomisation, or during the intervention and 12 week follow up&#xD;
             period (if after randomisation, will be excluded from per-protocol analysis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel A Toovey, PT, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Murdoch Childrens Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Monash Health</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Children's Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <reference>
    <citation>Toovey R, Harvey AR, McGinley JL, Lee KJ, Shih STF, Spittle AJ. Bike skills training for children with cerebral palsy: protocol for a randomised controlled trial. BMJ Open. 2018 Feb 3;8(2):e019898. doi: 10.1136/bmjopen-2017-019898.</citation>
    <PMID>29431140</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Murdoch Childrens Research Institute</investigator_affiliation>
    <investigator_full_name>Rachel Toovey</investigator_full_name>
    <investigator_title>PhD candidate | Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>motor learning</keyword>
  <keyword>participation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03003026
org study id: 36209
secondary id: S16-007
secondary id: HREC/116/RCHM/16
secondary id: RES-16-0000555X
nct id: NCT03003026
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
An assessor blinded multi-centre randomized controlled trial will be conducted in which 60
      participants will be randomized to either a novel task-specific approach to training bike
      skills or a parent-led home program comparison group. Baseline assessment will take place
      within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within a
      week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The
      primary outcome is attainment of individualised two-wheel bike specific goals at T1. All
      statistical analysis will be conducted on an intention-to-treat basis. Logistic regression
      will be used to assess the effect of providing the novel intervention compared to the
      parent-led home program on bike-specific goal attainment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Goal attainment at 1 week post the intervention period as measured by the Goal Attainment Scale (GAS)
time frame: 1 week following intervention
description: The GAS is a criterion referenced tool for individualized and collaborative goal setting between the child, family and therapist. Two to three individualized goals specific to two-wheel bike riding per participant will be set at the baseline visit with six potential outcomes specified for each goal from (-3 (deterioration), -2 (equal to start), -1 (less than expected), 0 (expected), 1 (somewhat more than expected), 2 (more than expected)). For each goal, attainment is defined as a score of zero or above on the GAS. The primary outcome, goal attainment, will be defined as attainment of at least one goal to an expected (score of zero) or greater level.
arm group label: Novel task-specific program
arm group type: Experimental
description: Intervention arm - see detailed intervention group description below
arm group label: Parent-led home-based program
arm group type: Active Comparator
description: Comparison arm - see detailed comparison group description below
intervention type: Other
intervention name: Novel task-specific bike skills training program
description: Participants randomised to the intervention group will participate in a novel task-specific bike skills training program. The intervention involves seven key components: it is group-based, intensive (2 hours per day for 3 days plus a home program for the remaining days of the one week period), task-specific, goal-directed, and therapist led, with parent involvement and conducted in an ecological setting. Each program will be run by a physiotherapist and allied health assistant during the school holidays.
arm group label: Novel task-specific program
intervention type: Other
intervention name: Parent-led home-based bike skills training program
description: The comparison group will involve a parent-led home-based bike skills training program. Parents of children randomized to the comparison group will receive written information and telephone support from a physiotherapist on training bike skills. They will be encouraged to work with their child towards their bike skills goals for at least 30-45 minutes per day over a one week period during the school holidays in home and community environments.
arm group label: Parent-led home-based program
criteria: 
gender: All
minimum age: 6 Years
maximum age: 15 Years
healthy volunteers: No
last name: Rachel A Toovey, PT, MPH
role: Principal Investigator
affiliation: Murdoch Childrens Research Institute
facility: 
facility: 
country: Australia
citation: Toovey R, Harvey AR, McGinley JL, Lee KJ, Shih STF, Spittle AJ. Bike skills training for children with cerebral palsy: protocol for a randomised controlled trial. BMJ Open. 2018 Feb 3;8(2):e019898. doi: 10.1136/bmjopen-2017-019898.
PMID: 29431140
responsible party type: Principal Investigator
investigator affiliation: Murdoch Childrens Research Institute
investigator full name: Rachel Toovey
investigator title: PhD candidate | Physiotherapist
mesh term: Cerebral Palsy
sharing ipd: No