<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/NCT02998281</url>
  </required_header>
  <id_info>
    <org_study_id>1234</org_study_id>
    <nct_id>NCT02998281</nct_id>
  </id_info>
  <brief_title>Effects of Inspiratory Muscle Training in Children With Cerebral Palsy</brief_title>
  <official_title>Effects of Inspiratory Muscle Training on Respiratory Functions, Trunk Control, Activities of Daily Living, Functional Exercise Capacity and Quality of Life in Children With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Even if cerebral palsy not directly effect respiratory system, impairment of nervous and&#xD;
      muscle systems, because of the brain damage, may cause respiratory functions impairment. In&#xD;
      literature, it has been showed that children with cerebral palsy have decreased respiratory&#xD;
      muscle strength and associated with trunk control, quality of life and respiratory functions.&#xD;
      But, there is no study in literature that aims to increase respiratory muscle strength in&#xD;
      these children. Hence, the aim of this study is to investigate effects of inspiratory muscle&#xD;
      training on respiratory functions, trunk control, activities of daily living, functional&#xD;
      exercise capacity and quality of life in children with cerebral palsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited&#xD;
      from Gazi University, Faculty of Health Science, Department of Physiotherapy and&#xD;
      Rehabilitation. Patients will randomly allocate to either a treatment group or control group.&#xD;
      The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth&#xD;
      pressure, the control group will receive sham inspiratory muscle training at a fixed work&#xD;
      load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7&#xD;
      days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function&#xD;
      test will be evaluated with using spirometry, respiratory muscle strength using with&#xD;
      electronic mouth pressure device, trunk control with using trunk control measurement scale,&#xD;
      activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI),&#xD;
      functional exercise capacity usin with six minute walk test (6MWT) and quality of life using&#xD;
      with Cerebral Palsy Quality of Life Questionnaire (CPQOL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timed Up and Go Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the child is expected to wear their regular footwear and use any mobility aids that they would normally require.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Activities of daily living using with Pediatric Evaluation of Disability Inventory</measure>
    <time_frame>6 weeks</time_frame>
    <description>PEDI scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Function Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory muscle strength</measure>
    <time_frame>6 weeks</time_frame>
    <description>Mouth pressure device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional exercise capacity</measure>
    <time_frame>6 weeks</time_frame>
    <description>six minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in trunk control over time assessed with Trunk Control Measurement Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessing change in trunk control</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Respiration; Decreased</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The treatment group received Inspiratory muscle training (IMT) at 40% of maximal mouth pressure (PImax) by using Threshold IMT and training loads were adjusted to maintain 40% of the PImax weekly. The PImax was measured at supervised sessions each week, and 40% of the measured value was determined as the new training work load.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The control group received sham Inspiratory muscle training (IMT) at a fixed work load, 5% of PImax by using Threshold IMT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Threshold (IMT)</intervention_name>
    <description>Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 7-14 years&#xD;
&#xD;
          -  Diagnosed to spastic cerebral palsy&#xD;
&#xD;
          -  Gross Motor Function Classification System levels I or II.&#xD;
&#xD;
          -  Have no earlier interventions in the form of orthopaedic surgery or injection with&#xD;
             botulinum toxin type A in the 6 month prior to baseline assessments&#xD;
&#xD;
          -  Child are able to demonstrate sufficient co-operation and cognitive understanding&#xD;
             participating&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active medical condition impairment (pneumonia etc.)&#xD;
&#xD;
          -  Do not accommodate the study&#xD;
&#xD;
          -  Do not want to attempt the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bulent Elbasan, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>September 27, 2018</last_update_submitted>
  <last_update_submitted_qc>September 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Muserrefe Nur Keles</investigator_full_name>
    <investigator_title>MSc Pt</investigator_title>
  </responsible_party>
  <keyword>cerebral palsy</keyword>
  <keyword>inspiratory muscle training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We have no decided yet</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/NCT02998281
org study id: 1234
nct id: NCT02998281
lead sponsor: 
has dmc: Yes
Even if cerebral palsy not directly effect respiratory system, impairment of nervous and
      muscle systems, because of the brain damage, may cause respiratory functions impairment. In
      literature, it has been showed that children with cerebral palsy have decreased respiratory
      muscle strength and associated with trunk control, quality of life and respiratory functions.
      But, there is no study in literature that aims to increase respiratory muscle strength in
      these children. Hence, the aim of this study is to investigate effects of inspiratory muscle
      training on respiratory functions, trunk control, activities of daily living, functional
      exercise capacity and quality of life in children with cerebral palsy.
A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited
      from Gazi University, Faculty of Health Science, Department of Physiotherapy and
      Rehabilitation. Patients will randomly allocate to either a treatment group or control group.
      The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth
      pressure, the control group will receive sham inspiratory muscle training at a fixed work
      load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7
      days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function
      test will be evaluated with using spirometry, respiratory muscle strength using with
      electronic mouth pressure device, trunk control with using trunk control measurement scale,
      activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI),
      functional exercise capacity usin with six minute walk test (6MWT) and quality of life using
      with Cerebral Palsy Quality of Life Questionnaire (CPQOL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Timed Up and Go Test
time frame: 6 weeks
description: this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the child is expected to wear their regular footwear and use any mobility aids that they would normally require.
measure: Activities of daily living using with Pediatric Evaluation of Disability Inventory
time frame: 6 weeks
description: PEDI scale
measure: Pulmonary Function Test
time frame: 6 weeks
description: spirometry
measure: Respiratory muscle strength
time frame: 6 weeks
description: Mouth pressure device
measure: Functional exercise capacity
time frame: 6 weeks
description: six minute walk test
measure: Change in trunk control over time assessed with Trunk Control Measurement Scale
time frame: 6 weeks
description: Assessing change in trunk control
arm group label: Treatment Group
arm group type: Active Comparator
description: The treatment group received Inspiratory muscle training (IMT) at 40% of maximal mouth pressure (PImax) by using Threshold IMT and training loads were adjusted to maintain 40% of the PImax weekly. The PImax was measured at supervised sessions each week, and 40% of the measured value was determined as the new training work load.
arm group label: Control Group
arm group type: Sham Comparator
description: The control group received sham Inspiratory muscle training (IMT) at a fixed work load, 5% of PImax by using Threshold IMT.
intervention type: Device
intervention name: Threshold (IMT)
description: Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated.
arm group label: Control Group
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: No
last name: Bulent Elbasan, Phd
role: Study Chair
affiliation: Gazi University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Muserrefe Nur Keles
investigator title: MSc Pt
mesh term: Respiratory Aspiration
mesh term: Paralysis
mesh term: Cerebral Palsy
sharing ipd: Undecided
ipd description: We have no decided yet