<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/NCT02193386</url>
  </required_header>
  <id_info>
    <org_study_id>S51880</org_study_id>
    <secondary_id>ML5982</secondary_id>
    <nct_id>NCT02193386</nct_id>
  </id_info>
  <brief_title>Evidence-based Physical Therapy in Children With Cerebral Palsy</brief_title>
  <official_title>Evidence-based Practice and Its Effectiveness in Physical Therapy Treatment of Children With Bilateral Spastic Cerebral Palsy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to evaluate evidence-based practice behavior in usual care physical therapy in&#xD;
      Flanders. Secondly, it aims to compare the effectiveness of a predefined physical therapy&#xD;
      program based on evidence-based guidelines to the effects of a period of usual care. It is&#xD;
      hypothesized that supporting therapists by providing a predefined evidence-based intervention&#xD;
      program, will result in an improved treatment outcome compared to the usual care physical&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants A convenience sample of 16 children will be recruited at the Cerebral Reference&#xD;
      Centre of the University Hospital Pellenberg. Children will be included when they are&#xD;
      diagnosed with bilateral spastic CP, aged between 4 and 9 years and a Gross Motor Function&#xD;
      level between I and III. Children are excluded when they received Botulinum Toxin A&#xD;
      injections within the past six months, orthopedic surgery in the past or had severe&#xD;
      associated problems that limited participation to therapy (blindness, deafness, severe&#xD;
      cognitive limitations or autism).&#xD;
&#xD;
      Design All children will start the study with a registration period. During this period, the&#xD;
      children's usual physical therapy (UC) will be registered using a diary. Immediately&#xD;
      following the UC period, children will be enrolled into a predefined intervention program&#xD;
      (IP).&#xD;
&#xD;
      Both the period of UC and IP will have a duration of 10 weeks. Before and after both periods,&#xD;
      children will be evaluated using the Gross Motor Function Measurement (GMFM-88) and&#xD;
      three-dimensional gait analysis (3DGA).&#xD;
&#xD;
      Therapy interventions During the period of UC, no specific intervention will be provided.&#xD;
      Children will receive the frequency, intensity and contents of therapy as they usually&#xD;
      receive by their own private physical therapist. A diary will be provided to the child's&#xD;
      physical therapist. The diary contains session forms, designed for the therapist to carefully&#xD;
      register the contents of therapy after each session.&#xD;
&#xD;
      In the session forms, the therapist will note down how much time of the therapy session will&#xD;
      target problems at the different levels of the ICF. At the level of body structure and&#xD;
      function, the time spent on muscle length and muscle strength will be registered. For muscle&#xD;
      length, the therapists are asked to report the targeted muscles, the number of repetitions,&#xD;
      the duration of stretch and treatment modality (activo, activopassivo or passivo). About&#xD;
      muscle strength, therapists will note the specific muscle that was trained, the intensity&#xD;
      (number of repetitions and resistance) and whether the exercise was performed as analytical&#xD;
      (single-joint) or functional (multiple-joint) muscle work. Concerning activity level, the&#xD;
      specific functional activity that was practiced and the averaged position in which this was&#xD;
      performed, will be registered. Finally, the therapist will be asked to report whether any&#xD;
      problems at participation level are specifically addressed.&#xD;
&#xD;
      During the period of UC, the therapist will not be contacted and no instructions or advice&#xD;
      will be provided regarding physical therapy treatment of the child.&#xD;
&#xD;
      Intervention period&#xD;
&#xD;
      Immediately following the UC period, children were enrolled into a predefined intervention&#xD;
      program (IP), designed by the first and third author of the study. The programs will be&#xD;
      executed by the child's personal physical therapist, who will agree to precisely follow the&#xD;
      prescribed program. Similar as for the UC program, the children will receive the frequency of&#xD;
      therapy as they usually receive by their own private physical therapist. Two different types&#xD;
      of programs were designed. Ten children received an individually defined, targeted program&#xD;
      tailored to the individual needs of the child and six children received a general program&#xD;
      based on general age-appropriate treatment aims for children with bilateral spastic CP. For&#xD;
      an extensive description of the differences and similarities between both types of&#xD;
      intervention programs, the authors refer to our previous intervention studies. All&#xD;
      intervention programs have two major common features. The first central and common aspect in&#xD;
      the intervention programs was that basic principles regarding evidence-based training were&#xD;
      respected. All programs consist of a predefined set of exercises to improve strength,&#xD;
      selectivity and mobility and a set of functional exercises. Thereby, stretching is prescribed&#xD;
      as three repetitions of 30 seconds and strength training was prescribed in series of three&#xD;
      times 12 to 15 repetitions. Functional exercises are not restricted to a specific repetition&#xD;
      number. As appropriate, all intervention programs will contain more than 50% of exercises at&#xD;
      activity and participation level. The second major common feature in the intervention&#xD;
      programs is the support and follow-up to the therapist. At the start of the intervention&#xD;
      study, therapists will be visited and the prescribed program will be thoroughly explained.&#xD;
      All exercises will be provided in a clear and structured way, with specific instructions&#xD;
      regarding anatomical position, sets and repetitions. The specific exercises will be discussed&#xD;
      and demonstrated if necessary. During the second or third week, the therapist will be&#xD;
      contacted by phone or email to discuss the progress of the program and the possible needs to&#xD;
      change and adjust exercises. Additionally, a follow-up visit will be organized around halfway&#xD;
      through the program. During this visit, the program will again discussed and the therapist&#xD;
      performed a regular therapy session using the program, in attendance of the first author of&#xD;
      the study. Difficulties in performance were discussed and if necessary, some exercises were&#xD;
      demonstrated. The opportunity for feedback on handling or position was thereby provided.&#xD;
&#xD;
      Due to these common aspects in our programs, and because previous data analysis revealed that&#xD;
      the overall effects of both programs were not found to be significantly different, we can&#xD;
      test our hypothesis regarding the influence of evidence-based support on the pooled data-set.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Gross Motor Function Measure - 88</measure>
    <time_frame>baseline, after 10 weeks of usual care and after 10 weeks of intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in three-dimensional gait analysis</measure>
    <time_frame>baseline, after 10 weeks of usual care and after 10 weeks intervention</time_frame>
    <description>Gait Profile Score, Movement Assessment Profiles and time-and distance parameters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No intervention, no follow-up, only registration of usual therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention period</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Predefined, evidence-based program and support</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention, no follow-up, only registration</intervention_name>
    <description>Usual Care</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention period</intervention_name>
    <description>Predefined intervention program</description>
    <arm_group_label>Intervention period</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cerebral Palsy&#xD;
&#xD;
          -  Age 4- 9 y&#xD;
&#xD;
          -  Gross Motor Function Classification I-III (ambulant)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe associated problems limiting participation to the programs&#xD;
&#xD;
          -  Severe musculoskeletal limitations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital Leuven (Pellenberg) - Reference centre for children with Cerebral Palsy</name>
      <address>
        <city>Pellenberg</city>
        <state>Flanders</state>
        <zip>3212</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2010</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cerebral Palsy</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>gait analysis</keyword>
  <keyword>gross motor function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <!-- 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/NCT02193386
org study id: S51880
secondary id: ML5982
nct id: NCT02193386
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The study aims to evaluate evidence-based practice behavior in usual care physical therapy in
      Flanders. Secondly, it aims to compare the effectiveness of a predefined physical therapy
      program based on evidence-based guidelines to the effects of a period of usual care. It is
      hypothesized that supporting therapists by providing a predefined evidence-based intervention
      program, will result in an improved treatment outcome compared to the usual care physical
      therapy.
Participants A convenience sample of 16 children will be recruited at the Cerebral Reference
      Centre of the University Hospital Pellenberg. Children will be included when they are
      diagnosed with bilateral spastic CP, aged between 4 and 9 years and a Gross Motor Function
      level between I and III. Children are excluded when they received Botulinum Toxin A
      injections within the past six months, orthopedic surgery in the past or had severe
      associated problems that limited participation to therapy (blindness, deafness, severe
      cognitive limitations or autism).

      Design All children will start the study with a registration period. During this period, the
      children's usual physical therapy (UC) will be registered using a diary. Immediately
      following the UC period, children will be enrolled into a predefined intervention program
      (IP).

      Both the period of UC and IP will have a duration of 10 weeks. Before and after both periods,
      children will be evaluated using the Gross Motor Function Measurement (GMFM-88) and
      three-dimensional gait analysis (3DGA).

      Therapy interventions During the period of UC, no specific intervention will be provided.
      Children will receive the frequency, intensity and contents of therapy as they usually
      receive by their own private physical therapist. A diary will be provided to the child's
      physical therapist. The diary contains session forms, designed for the therapist to carefully
      register the contents of therapy after each session.

      In the session forms, the therapist will note down how much time of the therapy session will
      target problems at the different levels of the ICF. At the level of body structure and
      function, the time spent on muscle length and muscle strength will be registered. For muscle
      length, the therapists are asked to report the targeted muscles, the number of repetitions,
      the duration of stretch and treatment modality (activo, activopassivo or passivo). About
      muscle strength, therapists will note the specific muscle that was trained, the intensity
      (number of repetitions and resistance) and whether the exercise was performed as analytical
      (single-joint) or functional (multiple-joint) muscle work. Concerning activity level, the
      specific functional activity that was practiced and the averaged position in which this was
      performed, will be registered. Finally, the therapist will be asked to report whether any
      problems at participation level are specifically addressed.

      During the period of UC, the therapist will not be contacted and no instructions or advice
      will be provided regarding physical therapy treatment of the child.

      Intervention period

      Immediately following the UC period, children were enrolled into a predefined intervention
      program (IP), designed by the first and third author of the study. The programs will be
      executed by the child's personal physical therapist, who will agree to precisely follow the
      prescribed program. Similar as for the UC program, the children will receive the frequency of
      therapy as they usually receive by their own private physical therapist. Two different types
      of programs were designed. Ten children received an individually defined, targeted program
      tailored to the individual needs of the child and six children received a general program
      based on general age-appropriate treatment aims for children with bilateral spastic CP. For
      an extensive description of the differences and similarities between both types of
      intervention programs, the authors refer to our previous intervention studies. All
      intervention programs have two major common features. The first central and common aspect in
      the intervention programs was that basic principles regarding evidence-based training were
      respected. All programs consist of a predefined set of exercises to improve strength,
      selectivity and mobility and a set of functional exercises. Thereby, stretching is prescribed
      as three repetitions of 30 seconds and strength training was prescribed in series of three
      times 12 to 15 repetitions. Functional exercises are not restricted to a specific repetition
      number. As appropriate, all intervention programs will contain more than 50% of exercises at
      activity and participation level. The second major common feature in the intervention
      programs is the support and follow-up to the therapist. At the start of the intervention
      study, therapists will be visited and the prescribed program will be thoroughly explained.
      All exercises will be provided in a clear and structured way, with specific instructions
      regarding anatomical position, sets and repetitions. The specific exercises will be discussed
      and demonstrated if necessary. During the second or third week, the therapist will be
      contacted by phone or email to discuss the progress of the program and the possible needs to
      change and adjust exercises. Additionally, a follow-up visit will be organized around halfway
      through the program. During this visit, the program will again discussed and the therapist
      performed a regular therapy session using the program, in attendance of the first author of
      the study. Difficulties in performance were discussed and if necessary, some exercises were
      demonstrated. The opportunity for feedback on handling or position was thereby provided.

      Due to these common aspects in our programs, and because previous data analysis revealed that
      the overall effects of both programs were not found to be significantly different, we can
      test our hypothesis regarding the influence of evidence-based support on the pooled data-set.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Gross Motor Function Measure - 88
time frame: baseline, after 10 weeks of usual care and after 10 weeks of intervention
measure: Change in three-dimensional gait analysis
time frame: baseline, after 10 weeks of usual care and after 10 weeks intervention
description: Gait Profile Score, Movement Assessment Profiles and time-and distance parameters
arm group label: Usual Care
arm group type: Active Comparator
description: No intervention, no follow-up, only registration of usual therapy
arm group label: Intervention period
arm group type: Experimental
description: Predefined, evidence-based program and support
intervention type: Other
intervention name: No intervention, no follow-up, only registration
description: Usual Care
arm group label: Usual Care
intervention type: Other
intervention name: Intervention period
description: Predefined intervention program
arm group label: Intervention period
criteria: 
gender: All
minimum age: 4 Years
maximum age: 9 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Paralysis
mesh term: Cerebral Palsy