<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/NCT03832491</url>
  </required_header>
  <id_info>
    <org_study_id>KA-180026</org_study_id>
    <nct_id>NCT03832491</nct_id>
  </id_info>
  <brief_title>Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia</brief_title>
  <official_title>Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Impaired pulmonary function, decreased physical activity, functional capacity and depending&#xD;
      on these factors are reported in patients with primary ciliary dyskinesia in recent studies.&#xD;
      The purpose of this study to evaluate the effects of game based approach on pulmonary&#xD;
      function, functional capacity and quality of life in patients with primary ciliary dykinesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary ciliary dyskinesia (PCD) is an autosomal recessive hereditary disorder characterized&#xD;
      by congenital structural abnormalities and impairment of respiratory function. Mucociliary&#xD;
      clearance is affected by disorders in the structure and movement of cilia. That causes&#xD;
      repeated infections in the upper and lower respiratory tract.In addition to mucociliary&#xD;
      effects and impaired lung function, it is thought that there may be a decrease in respiratory&#xD;
      muscle strength and functional capacity. One of the factors affecting functional capacity is&#xD;
      the level of physical activity. For these reasons, the management of the respiratory system&#xD;
      in patients with PCD is very important. In addition to airway clearence techniques,&#xD;
      approaches to increase physical activity are also important. It was thought that severe&#xD;
      physical activity could be an important determinant of cardiopulmonary functional capacity in&#xD;
      patients with mild to moderate PCD. The level of physical activity is known to be associated&#xD;
      with quality of life.&#xD;
&#xD;
      In literature no study investigated the effects of game based approach on oxygenation,&#xD;
      functional capacity and quality of life in patients with PCD. Game based approach is a new&#xD;
      method lead to increase physical activity. In literature there is no study investigated the&#xD;
      effects of game based approach on oxygenation, functional capacity and quality of life in&#xD;
      patients with PCD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2019</start_date>
  <completion_date type="Actual">February 5, 2020</completion_date>
  <primary_completion_date type="Actual">February 5, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional capacity using six minute walk test</measure>
    <time_frame>Change from baseline distance of six minute walk test in 8 weeks</time_frame>
    <description>Six minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distance of six minute walk test</measure>
    <time_frame>Change from baseline distance of six minute walk test in 8 weeks</time_frame>
    <description>The distance walked will be recorded as meters at the end of 6 minute walk test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic features-Age</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>The age will be recorded in years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic features-Weight</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Weight will be recorded in kilograms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic features-Lenght</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>The length will be saved in meters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic features-Body Mass Index</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Body mass index will be calculated by dividing the weight by the square of the height (kg/m^2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs-Heart Rate</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Heart rate will be recorded before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated game and kinect games. The number of heart beats per minute will be evaluated before and after the tests to measure how much it has changed in 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs-Systolic Blood Pressure</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Systolic blood pressure will be measued before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. The systolic blood pressure will be evaluated before and after the tests to measure how much it has changed in 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs-Diastolic Blood Pressure</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Diastolic blood pressure will be measued before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. The diastolic blood pressure will be evaluated before and after the tests to measure how much it has changed in 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs-Respiratory Rate</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Respiratory rate will be recorded before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. The respiratory rate will be evaluated before and after the tests to measure how much it has changed in 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs-Perception of dyspnea</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Perception of dyspnea will be evaluated by the OMNI scale before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. OMNI is a perceived exertion scale as BORG perceived exertion scale. The term OMNI is an acronym for the word omnibus. This perceived exertion scale includes numerical categories from 0 to 10. The numbers on the scale show a range of exertion levels from extremely easy (0) to extremely hard (10). The perception of dyspnea will be evaluated before and after the tests to measure how much it has changed in 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of general fatigue</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Perception of fatigue will be assessed by the OMNI scale before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games.OMNI is a perceived exertion scale as BORG perceived exertion scale.The term OMNI is an acronym for the word omnibus. This perceived exertion scale includes numerical categories from 0 to 10. The numbers on the scale show a range of exertion levels from extremely easy (0) to extremely hard (10). The perception of general fatigue will be evaluated before and after the tests to measure how much it has changed in 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of quadriceps fatigue</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Perception of quadriceps fatigue will be assessed by the OMNI scale before and after six minute walk test, shuttle walk test, glittre ADL test,playing seated games and kinect games. OMNI scale is a perceived exertion scale as BORG scale. The term OMNI is an acronym for the word omnibus. This perceived exertion scale includes numerical categories from 0 to 10. The numbers on the scale show a range of exertion levels from extremely easy (0) to extremely hard (10). The perception of quadriceps fatigue will be evaluated before and after the tests to measure how much it has changed in 8 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Pulmonary function assessed by the spirometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory muscle strength</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral muscle strength</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Peripheral muscle strength will be assessed by the hand held dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statical Balance</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Statical balance will ve assessed by the flamingo balance test. The test evaluates the postural balance.In this test, a metal or wooden beam with a length of 50 cm, a height of 4 cm and a width of 3 cm is used. During this test, the participant tries to stand with a single foot in a manner similar to the flamingo position for as long as possible on the long axis of the beam. The stopwatch starts with the command. When the balance is distorted, the time is stopped and the time progresses until the next equilibrium loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loss of balance of Flamingo Balance Test</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Balance disturbances within 1 min are counted. If there is more than 15 loss of balance within the first 30s, the test is terminated and zero score is given.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic Balance</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Dynamic balance will be evaluated by the Y balance test. The test extends to the directions determined by the lower limb of the participant and assesses the stability and stability of the participant on the other.In the test setup, 3 pieces of tape measure will be glued to the floor in an angle of 120 degrees. At the intersection of these 3 scales, one will be asked to stand on one foot with the other foot in 3 directions as anterior, posteromedial and posterolateral. At this time, the participant's balance, not to stand on the foot of the heel of the feet to stand up and extend the finger tips of the feet will be careful to touch slightly. At the end of each test, the participant will be asked to bring his foot to the side of his foot without losing the balance and touching the floor. This application will be repeated 3 times for each test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extending distance in Y Balance Test</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Extending distance will be recorded as centimeter (cm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Physical Activity</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Subjective physical activity will ve assessed by the Bouchard Three-Day Physical Activity Questionnaire. It queries the individual's level of physical activity on weekdays and at the weekend.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily energy consumption in the Bouchard Three-Day Physical Activity Questionnare</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>The average energy calculation in kilocalories per kilogram at intervals of fifteen minutes is used to calculate daily energy consumption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Physical Activity</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>The objective physical activity will be evaluated by the SenseWear Armband which has three-axis accelerometer sensors during the Glittre Activity of Daily Living Test. Energy consumption will be calculated as metabolic equivalent of task (MET).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy expenditure while playing seated games.</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Energy expenditure will be evaluated by Sense Wear Armband while playing seated games.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy expenditure while playing each kinect games.</measure>
    <time_frame>Week one and half</time_frame>
    <description>Energy expenditure will be assessed by Sense Wear Armband before starting to play each kinect games to determine how much energy consumption level of the games has reached during the session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of Daily Living</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Activity of daily living will ve evaluated by the Glittre Activity of DailyLiving (ADL) test. Glittre ADL test is a test that provides standardized functional status assessment including activities similar to daily living activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygenation using wearable lactate measuring instrument (BSX insight device) during Incremental Shuttle Walk Test.</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>1. The device is a portable NIRS LED device used to determine lactate level during the movement. BSX is housed in a compression sleeve and fitted over the gastrocnemius muscle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygenation using wearable lactate measuring instrument (BSX insight device) during Glittre Activity of Daily Living Test.</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>1. The device is a portable NIRS LED device used to determine lactate level during the movement. BSX is housed in a compression sleeve and fitted over the gastrocnemius muscle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise capacity using incremental shuttle walk test.</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>Incremental shuttle walk test will be performed in a enclosed corridor. Patients are required to turn around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients will follow the rhythm dictated by the audio signal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of daily living using disease specific questioannare-Version2 (QOL-PCDV2)</measure>
    <time_frame>Before and after 8 weeks</time_frame>
    <description>The Turkish version of QOL-PCD will be used. The questionnare evaluate physical, social and emotional status in different age groups (pediatrics, adolescents, adults and parents).The total numbers of items in the questionnaires are 35 questions for parents' , 32 questions for children, 38 questions for adolescents, 40 questions for adults.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Primary Ciliary Dyskinesia</condition>
  <condition>Kartagener Syndrome</condition>
  <condition>Immotile Cilia Syndrome</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Home Based Therapy: 16 patients with PCD&#xD;
Airway clearence techniques, everday of the week, during eight weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Game and home based therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Game based approach programme: 16 patients with PCD&#xD;
Game based approach programme will be done using the exergame with the game console, fourty minutes three times per week for eight weeks.&#xD;
Exergame includes five games selected from two kinects games CD. Each game will be played for five games set.&#xD;
Airway clearence techniques, everday of the week, during eight weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home based therapy</intervention_name>
    <description>Airway clearence techniques</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Game and home based therapy</intervention_name>
    <description>Game based approach programme and airway clearence techniques</description>
    <arm_group_label>Game and home based therapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being diagnosed with PCD&#xD;
&#xD;
          -  Being clinically stable&#xD;
&#xD;
          -  Between 6-18 years old&#xD;
&#xD;
          -  Volunteer to participate in research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not having a stable clinical condition&#xD;
&#xD;
          -  Patients with severe neuromuscular, musculoskeletal and rheumatological problems&#xD;
&#xD;
          -  Patients with loss of balance&#xD;
&#xD;
          -  Not being cooperative&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hazal Sonbahar Ulu, MSc, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Deniz Inal Ince, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hayriye Ugur Ozcelik, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Hazal Sonbahar Ulu</investigator_full_name>
    <investigator_title>MSc, PT</investigator_title>
  </responsible_party>
  <keyword>Primary Ciliary Dyskinesia</keyword>
  <keyword>Kartegener Syndrome</keyword>
  <keyword>Immotile Cilia Syndrome</keyword>
  <keyword>Pulmonary Rehabilitation</keyword>
  <keyword>Airway Clearance Techniques</keyword>
  <keyword>Exergame</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ciliary Motility Disorders</mesh_term>
    <mesh_term>Kartagener Syndrome</mesh_term>
    <mesh_term>Dyskinesias</mesh_term>
    <mesh_term>Syndrome</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/NCT03832491
org study id: KA-180026
nct id: NCT03832491
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Impaired pulmonary function, decreased physical activity, functional capacity and depending
      on these factors are reported in patients with primary ciliary dyskinesia in recent studies.
      The purpose of this study to evaluate the effects of game based approach on pulmonary
      function, functional capacity and quality of life in patients with primary ciliary dykinesia.
Primary ciliary dyskinesia (PCD) is an autosomal recessive hereditary disorder characterized
      by congenital structural abnormalities and impairment of respiratory function. Mucociliary
      clearance is affected by disorders in the structure and movement of cilia. That causes
      repeated infections in the upper and lower respiratory tract.In addition to mucociliary
      effects and impaired lung function, it is thought that there may be a decrease in respiratory
      muscle strength and functional capacity. One of the factors affecting functional capacity is
      the level of physical activity. For these reasons, the management of the respiratory system
      in patients with PCD is very important. In addition to airway clearence techniques,
      approaches to increase physical activity are also important. It was thought that severe
      physical activity could be an important determinant of cardiopulmonary functional capacity in
      patients with mild to moderate PCD. The level of physical activity is known to be associated
      with quality of life.

      In literature no study investigated the effects of game based approach on oxygenation,
      functional capacity and quality of life in patients with PCD. Game based approach is a new
      method lead to increase physical activity. In literature there is no study investigated the
      effects of game based approach on oxygenation, functional capacity and quality of life in
      patients with PCD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Functional capacity using six minute walk test
time frame: Change from baseline distance of six minute walk test in 8 weeks
description: Six minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions.
measure: Distance of six minute walk test
time frame: Change from baseline distance of six minute walk test in 8 weeks
description: The distance walked will be recorded as meters at the end of 6 minute walk test.
measure: Demographic features-Age
time frame: Before and after 8 weeks
description: The age will be recorded in years.
measure: Demographic features-Weight
time frame: Before and after 8 weeks
description: Weight will be recorded in kilograms.
measure: Demographic features-Lenght
time frame: Before and after 8 weeks
description: The length will be saved in meters.
measure: Demographic features-Body Mass Index
time frame: Before and after 8 weeks
description: Body mass index will be calculated by dividing the weight by the square of the height (kg/m^2).
measure: Vital Signs-Heart Rate
time frame: Before and after 8 weeks
description: Heart rate will be recorded before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated game and kinect games. The number of heart beats per minute will be evaluated before and after the tests to measure how much it has changed in 8 weeks.
measure: Vital Signs-Systolic Blood Pressure
time frame: Before and after 8 weeks
description: Systolic blood pressure will be measued before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. The systolic blood pressure will be evaluated before and after the tests to measure how much it has changed in 8 weeks.
measure: Vital Signs-Diastolic Blood Pressure
time frame: Before and after 8 weeks
description: Diastolic blood pressure will be measued before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. The diastolic blood pressure will be evaluated before and after the tests to measure how much it has changed in 8 weeks.
measure: Vital Signs-Respiratory Rate
time frame: Before and after 8 weeks
description: Respiratory rate will be recorded before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. The respiratory rate will be evaluated before and after the tests to measure how much it has changed in 8 weeks.
measure: Vital Signs-Perception of dyspnea
time frame: Before and after 8 weeks
description: Perception of dyspnea will be evaluated by the OMNI scale before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games. OMNI is a perceived exertion scale as BORG perceived exertion scale. The term OMNI is an acronym for the word omnibus. This perceived exertion scale includes numerical categories from 0 to 10. The numbers on the scale show a range of exertion levels from extremely easy (0) to extremely hard (10). The perception of dyspnea will be evaluated before and after the tests to measure how much it has changed in 8 weeks.
measure: Perception of general fatigue
time frame: Before and after 8 weeks
description: Perception of fatigue will be assessed by the OMNI scale before and after six minute walk test, shuttle walk test, glittre ADL test, playing seated games and kinect games.OMNI is a perceived exertion scale as BORG perceived exertion scale.The term OMNI is an acronym for the word omnibus. This perceived exertion scale includes numerical categories from 0 to 10. The numbers on the scale show a range of exertion levels from extremely easy (0) to extremely hard (10). The perception of general fatigue will be evaluated before and after the tests to measure how much it has changed in 8 weeks.
measure: Perception of quadriceps fatigue
time frame: Before and after 8 weeks
description: Perception of quadriceps fatigue will be assessed by the OMNI scale before and after six minute walk test, shuttle walk test, glittre ADL test,playing seated games and kinect games. OMNI scale is a perceived exertion scale as BORG scale. The term OMNI is an acronym for the word omnibus. This perceived exertion scale includes numerical categories from 0 to 10. The numbers on the scale show a range of exertion levels from extremely easy (0) to extremely hard (10). The perception of quadriceps fatigue will be evaluated before and after the tests to measure how much it has changed in 8 weeks.
measure: Pulmonary function
time frame: Before and after 8 weeks
description: Pulmonary function assessed by the spirometer
measure: Respiratory muscle strength
time frame: Before and after 8 weeks
description: Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.
measure: Peripheral muscle strength
time frame: Before and after 8 weeks
description: Peripheral muscle strength will be assessed by the hand held dynamometer.
measure: Statical Balance
time frame: Before and after 8 weeks
description: Statical balance will ve assessed by the flamingo balance test. The test evaluates the postural balance.In this test, a metal or wooden beam with a length of 50 cm, a height of 4 cm and a width of 3 cm is used. During this test, the participant tries to stand with a single foot in a manner similar to the flamingo position for as long as possible on the long axis of the beam. The stopwatch starts with the command. When the balance is distorted, the time is stopped and the time progresses until the next equilibrium loss.
measure: Loss of balance of Flamingo Balance Test
time frame: Before and after 8 weeks
description: Balance disturbances within 1 min are counted. If there is more than 15 loss of balance within the first 30s, the test is terminated and zero score is given.
measure: Dynamic Balance
time frame: Before and after 8 weeks
description: Dynamic balance will be evaluated by the Y balance test. The test extends to the directions determined by the lower limb of the participant and assesses the stability and stability of the participant on the other.In the test setup, 3 pieces of tape measure will be glued to the floor in an angle of 120 degrees. At the intersection of these 3 scales, one will be asked to stand on one foot with the other foot in 3 directions as anterior, posteromedial and posterolateral. At this time, the participant's balance, not to stand on the foot of the heel of the feet to stand up and extend the finger tips of the feet will be careful to touch slightly. At the end of each test, the participant will be asked to bring his foot to the side of his foot without losing the balance and touching the floor. This application will be repeated 3 times for each test.
measure: Extending distance in Y Balance Test
time frame: Before and after 8 weeks
description: Extending distance will be recorded as centimeter (cm).
measure: Subjective Physical Activity
time frame: Before and after 8 weeks
description: Subjective physical activity will ve assessed by the Bouchard Three-Day Physical Activity Questionnaire. It queries the individual's level of physical activity on weekdays and at the weekend.
measure: Daily energy consumption in the Bouchard Three-Day Physical Activity Questionnare
time frame: Before and after 8 weeks
description: The average energy calculation in kilocalories per kilogram at intervals of fifteen minutes is used to calculate daily energy consumption.
measure: Objective Physical Activity
time frame: Before and after 8 weeks
description: The objective physical activity will be evaluated by the SenseWear Armband which has three-axis accelerometer sensors during the Glittre Activity of Daily Living Test. Energy consumption will be calculated as metabolic equivalent of task (MET).
measure: Energy expenditure while playing seated games.
time frame: Before and after 8 weeks
description: Energy expenditure will be evaluated by Sense Wear Armband while playing seated games.
measure: Energy expenditure while playing each kinect games.
time frame: Week one and half
description: Energy expenditure will be assessed by Sense Wear Armband before starting to play each kinect games to determine how much energy consumption level of the games has reached during the session.
measure: Activity of Daily Living
time frame: Before and after 8 weeks
description: Activity of daily living will ve evaluated by the Glittre Activity of DailyLiving (ADL) test. Glittre ADL test is a test that provides standardized functional status assessment including activities similar to daily living activities.
measure: Oxygenation using wearable lactate measuring instrument (BSX insight device) during Incremental Shuttle Walk Test.
time frame: Before and after 8 weeks
description: 1. The device is a portable NIRS LED device used to determine lactate level during the movement. BSX is housed in a compression sleeve and fitted over the gastrocnemius muscle.
measure: Oxygenation using wearable lactate measuring instrument (BSX insight device) during Glittre Activity of Daily Living Test.
time frame: Before and after 8 weeks
description: 1. The device is a portable NIRS LED device used to determine lactate level during the movement. BSX is housed in a compression sleeve and fitted over the gastrocnemius muscle.
measure: Exercise capacity using incremental shuttle walk test.
time frame: Before and after 8 weeks
description: Incremental shuttle walk test will be performed in a enclosed corridor. Patients are required to turn around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients will follow the rhythm dictated by the audio signal
measure: Quality of daily living using disease specific questioannare-Version2 (QOL-PCDV2)
time frame: Before and after 8 weeks
description: The Turkish version of QOL-PCD will be used. The questionnare evaluate physical, social and emotional status in different age groups (pediatrics, adolescents, adults and parents).The total numbers of items in the questionnaires are 35 questions for parents' , 32 questions for children, 38 questions for adolescents, 40 questions for adults.
arm group label: Control Group
arm group type: Other
description: Home Based Therapy: 16 patients with PCD
Airway clearence techniques, everday of the week, during eight weeks
arm group label: Game and home based therapy group
arm group type: Experimental
description: Game based approach programme: 16 patients with PCD
Game based approach programme will be done using the exergame with the game console, fourty minutes three times per week for eight weeks.
Exergame includes five games selected from two kinects games CD. Each game will be played for five games set.
Airway clearence techniques, everday of the week, during eight weeks
intervention type: Other
intervention name: Home based therapy
description: Airway clearence techniques
arm group label: Control Group
intervention type: Other
intervention name: Game and home based therapy
description: Game based approach programme and airway clearence techniques
arm group label: Game and home based therapy group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Hazal Sonbahar Ulu, MSc, PT
role: Principal Investigator
affiliation: Hacettepe University
last name: Deniz Inal Ince, Prof. Dr.
role: Study Chair
affiliation: Hacettepe University
last name: Hayriye Ugur Ozcelik, Prof. Dr.
role: Study Director
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Hazal Sonbahar Ulu
investigator title: MSc, PT
mesh term: Ciliary Motility Disorders
mesh term: Kartagener Syndrome
mesh term: Dyskinesias
mesh term: Syndrome
sharing ipd: No