<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/NCT04411927</url>
  </required_header>
  <id_info>
    <org_study_id>children with CKD</org_study_id>
    <nct_id>NCT04411927</nct_id>
  </id_info>
  <brief_title>Impact of Chronic Kidney Disease on Postural Stability in Children</brief_title>
  <official_title>Impact of Chronic Kidney Disease on Postural Stability in Children: A Cross-sectional Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Background: Chronic kidney disease is associated with comorbid conditions that result in&#xD;
      physical impairments.&#xD;
&#xD;
      Objectives: Investigate the impact of chronic kidney disease (CKD) on postural stability in&#xD;
      children compared with age matched typically developing children using Human Assessment&#xD;
      Computer (HUMAC) balance system.&#xD;
&#xD;
      Design: An observational design (cross-sectional study). Settings: The assessment procedures&#xD;
      were conducted at the Nephrology Unit, Zagazig University Hospitals.&#xD;
&#xD;
      Participants: Seventy-five children, age ranged from 8 to 15 years represented three groups&#xD;
      of equal numbers; control group (typically developed), non-dialysis (stage 3 and 4) and&#xD;
      hemodialysis group.&#xD;
&#xD;
      Outcome measures: The HUMAC balance system was used to assess the limits of stability, center&#xD;
      of pressure and sensory organization and balance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods Study design This study is an observational cross-sectional design (prospective&#xD;
      database study).&#xD;
&#xD;
      Participants and setting Participants included children with CKD extracted from a data set of&#xD;
      731 individuals with CKD diagnoses, who receive regular medical follow-up/hemodialysis at&#xD;
      Nephrology Unit, Zagazig University Hospitals. The study was conducted from January 2018 to&#xD;
      January 2020 in accordance with the Declaration of Helsinki (Code of Ethics of the World&#xD;
      Medical Association). The study protocol was approved by the Ethical committee of the Faculty&#xD;
      of Physical Therapy, Cairo University, Egypt (No.P.T.REC/012/002169). Children's&#xD;
      par-ticipation was authorized by a signed written consent form with parent's/legal guardian's&#xD;
      acceptance for participation before starting the study procedures.&#xD;
&#xD;
      Participants Fifty eligible volunteer children with CKD were recruited from Nephrology Unit,&#xD;
      Zagazig University Hospitals to be enrolled in this study and allocated into either&#xD;
      hemodialysis (on hemodialysis) or non-dialysis group (children at stage 3 and 4).&#xD;
&#xD;
      Eligible criteria:&#xD;
&#xD;
        -  Medically diagnosed with CKD (regardless of medical history),&#xD;
&#xD;
        -  Age ranged from eight to fifteen years,&#xD;
&#xD;
        -  Both genders&#xD;
&#xD;
      Participants were excluded if they had:&#xD;
&#xD;
        -  Communication problems such as intellectual disability, autism, Down syndrome, or&#xD;
           cerebral palsy,&#xD;
&#xD;
        -  Significant visual or hearing problems,&#xD;
&#xD;
        -  Any neurological and/or musculoskeletal disorders which influence postural stability,&#xD;
&#xD;
        -  Chronic cardiovascular or pulmonary disorders. Twenty-five volunteer typically developed&#xD;
           age matched group were enrolled as control group.&#xD;
&#xD;
      Basic demographic and clinical information Demographics and physical characteristics (age,&#xD;
      sex, weight, height) and clinical data (renal function test, recent hematology and blood&#xD;
      chemistry counts, co-morbidity, and medication) were recorded from medical reports to confirm&#xD;
      diagnosis.&#xD;
&#xD;
      Study power and sample size Sample size was predestined before conducting the study by&#xD;
      G*POWER statistical software (Franz Faul, Universitat Kiel, Germany; version 3.1.9.2) [F&#xD;
      tests- ANOVA: Fixed effects, one-way, α=0.05, β=0.2, and large effect size] with the number&#xD;
      of groups=3, giving a total number of 66 participants to be recruited in this study.&#xD;
&#xD;
      2.5. Outcome measures The Human Assessment Computer (HUMAC) Balance System, primarily being&#xD;
      part of a video game appliance (Wii Balance Board), is a distinct technology used in&#xD;
      assessment and rehabilitation of postural control. It is an affordable, portable and&#xD;
      prevalent obtainable force plate provides the patient and tester with visual feedback as well&#xD;
      as numerical data. The system displays several reporting options with objective datum&#xD;
      providing clinicians with comprehensive case progression which is used for baseline and&#xD;
      follow-up analysis with eight programs to choose from (HUMAC balance, 2017; Blosch et al.,&#xD;
      2019). The HUMAC-type technology has been found to detect more imbalances than traditional&#xD;
      tests (Merchant-Borna et al., 2017). In the current study limits of stability, COP and the&#xD;
      Clinical Test of Sensory Organization and Balance (CTSIB) were assessed. Each child in the&#xD;
      three study groups performed three trials and the mean value was estimated for each test.&#xD;
&#xD;
      2.5.1. Limits of Stability test: Limits of stability are known as the furthest distance a&#xD;
      subject is capable to shift his/her COP in different directions whilst keeping the&#xD;
      configuration of the BOS and adjust the body position. This commonly requires the use of a&#xD;
      force plate that records COP movement and a visual feedback that serves to maximize COP&#xD;
      displacement in certain directions (Lemay et al., 2014). During this test, the participant is&#xD;
      instructed to shift the round cursor on the screen (the COP) to the highlighted target. As&#xD;
      he/she remains in the target for the hold time, this target point is deactivated and should&#xD;
      move between the center targets to each surrounding target in a random order. A count-up&#xD;
      timer displays the total test time. He/she must return to the center target after each outer&#xD;
      target. The test was conducted at two levels 4 and 6. At level 4; this is considered as&#xD;
      simple test compared with level 6; the distance between center targets to each surrounding&#xD;
      target is relatively small. On the other hand, at level 6 the distance between center targets&#xD;
      to each surrounding target is larger.&#xD;
&#xD;
      2.5.2. Center of pressure test This test is used to measure the variation in a subject's COP&#xD;
      and displays his/her Right/Left and Anterior/Posterior weight distribution. In the current&#xD;
      study, the COP test variables recorded were the stability score and path length.&#xD;
&#xD;
        -  Stability test: It measures the participant's ability to stabilize his/her balance at&#xD;
           locations around their neutral position. Results are reported as the percent of time a&#xD;
           subject holds his COP in each of the eight flashing targets in clockwise order&#xD;
           (right/left and anterior/posterior weight distribution). These targets are eight&#xD;
           specific points in which the current target flashes green when the participant is&#xD;
           on-target and flashes yellow when he is off-target. The HUMAC system provides a&#xD;
           counts-down of the hold time to inform the participant when he/she should move to the&#xD;
           next target. In addition, the system provides variety of levels based on the distance&#xD;
           from the center to the farthest target.&#xD;
&#xD;
        -  Path length: The COP path length represents the COP displacement in which lower values&#xD;
           indicate better performance (Ju-Hyeong et al., 2020).&#xD;
&#xD;
      2.5.3. Clinical Test of Sensory Organization and Balance: It is sometimes referred as the&#xD;
      Romberg or Foam and Dome test. It is used to test how a participant's vestibular,&#xD;
      somatosensory and visual systems integrate in the conditions of open and closed eyes compared&#xD;
      to a normal population. The CTSIB protocol typically uses four conditions including eyes&#xD;
      closed soft surface (ECSS); eyes closed firm surface (ECFS); eyes open soft surface (EOSS);&#xD;
      Eye open soft surface (EOSS) and eyes open firm surface (EOFS). The participant was&#xD;
      instructed to stand in a neutral position with the arms at body sides. Each participant went&#xD;
      through a series of the four tests, which were each 30 seconds long. As participants&#xD;
      completed the test, the board monitored their COG to determine their stability and path&#xD;
      length. The requirements of the assessment were clearly demonstrated to all children. The&#xD;
      assessment procedures were administered following the HUMAC Balance System manual detailed&#xD;
      instructions. All participants performed three trials of each test, each lasting 30 seconds&#xD;
      to determine the stability score and path length.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">January 20, 2020</completion_date>
  <primary_completion_date type="Actual">January 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>limits of stability test</measure>
    <time_frame>from January 2018 to January 2020</time_frame>
    <description>it was measured by the HUMAC. higher scores indicate good balance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>center of pressure (COP) test</measure>
    <time_frame>from January 2018 to January 2020</time_frame>
    <description>It was measured by the HUMAC balance system. COP is represented by&#xD;
path length higher scores indicate poor balance&#xD;
stability score with higher results indicate good balance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Test of Sensory Organization and Balance</measure>
    <time_frame>from January 2018 to January 2020</time_frame>
    <description>it was measured by the HUMAc balance system to represent the ability of the child to keep balance while standing on firm and solid surfaces alternatively with eyes open and then eyes closed</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">75</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>this group included 25 typically developed children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>on-heamodialysis group</arm_group_label>
    <description>this group included children with CKD on-heamodialysis treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-dialysis group</arm_group_label>
    <description>this group included children with CKD who don't require dialysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>assessment of postural stability</intervention_name>
    <description>assessment of postural stability</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>non-dialysis group</arm_group_label>
    <arm_group_label>on-heamodialysis group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Fifty eligible volunteer children with CKD were recruited from Nephrology Unit, Zagazig&#xD;
        University Hospitals to be enrolled in this study and allocated into either hemodialysis&#xD;
        (on hemodialysis) or non-dialysis group (children at stage 3 and 4).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically diagnosed with CKD (regardless of medical history),&#xD;
&#xD;
          -  Age ranged from eight to fifteen years,&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants were excluded if they had:&#xD;
&#xD;
          -  Communication problems such as intellectual disability, autism, Down syndrome, or&#xD;
             cerebral palsy,&#xD;
&#xD;
          -  Significant visual or hearing problems,&#xD;
&#xD;
          -  Any neurological and/or musculoskeletal disorders which influence postural stability,&#xD;
&#xD;
          -  Chronic cardiovascular or pulmonary disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nanees E Mohamed</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Faika S Arab</last_name>
    <role>Study Director</role>
    <affiliation>zagazieg university, Egypt</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nourhan M Baiomy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo university, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>faculty of physical therapy, Cairo university</name>
      <address>
        <city>Giza</city>
        <zip>12662</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Amira Mahmoud Abd-elmonem</investigator_full_name>
    <investigator_title>Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university</investigator_title>
  </responsible_party>
  <keyword>Balance</keyword>
  <keyword>Chronic kidney disease</keyword>
  <keyword>HUMAC balance system</keyword>
  <keyword>Postural stability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04411927
org study id: children with CKD
nct id: NCT04411927
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Chronic kidney disease is associated with comorbid conditions that result in
      physical impairments.

      Objectives: Investigate the impact of chronic kidney disease (CKD) on postural stability in
      children compared with age matched typically developing children using Human Assessment
      Computer (HUMAC) balance system.

      Design: An observational design (cross-sectional study). Settings: The assessment procedures
      were conducted at the Nephrology Unit, Zagazig University Hospitals.

      Participants: Seventy-five children, age ranged from 8 to 15 years represented three groups
      of equal numbers; control group (typically developed), non-dialysis (stage 3 and 4) and
      hemodialysis group.

      Outcome measures: The HUMAC balance system was used to assess the limits of stability, center
      of pressure and sensory organization and balance.
Methods Study design This study is an observational cross-sectional design (prospective
      database study).

      Participants and setting Participants included children with CKD extracted from a data set of
      731 individuals with CKD diagnoses, who receive regular medical follow-up/hemodialysis at
      Nephrology Unit, Zagazig University Hospitals. The study was conducted from January 2018 to
      January 2020 in accordance with the Declaration of Helsinki (Code of Ethics of the World
      Medical Association). The study protocol was approved by the Ethical committee of the Faculty
      of Physical Therapy, Cairo University, Egypt (No.P.T.REC/012/002169). Children's
      par-ticipation was authorized by a signed written consent form with parent's/legal guardian's
      acceptance for participation before starting the study procedures.

      Participants Fifty eligible volunteer children with CKD were recruited from Nephrology Unit,
      Zagazig University Hospitals to be enrolled in this study and allocated into either
      hemodialysis (on hemodialysis) or non-dialysis group (children at stage 3 and 4).

      Eligible criteria:

        -  Medically diagnosed with CKD (regardless of medical history),

        -  Age ranged from eight to fifteen years,

        -  Both genders

      Participants were excluded if they had:

        -  Communication problems such as intellectual disability, autism, Down syndrome, or
           cerebral palsy,

        -  Significant visual or hearing problems,

        -  Any neurological and/or musculoskeletal disorders which influence postural stability,

        -  Chronic cardiovascular or pulmonary disorders. Twenty-five volunteer typically developed
           age matched group were enrolled as control group.

      Basic demographic and clinical information Demographics and physical characteristics (age,
      sex, weight, height) and clinical data (renal function test, recent hematology and blood
      chemistry counts, co-morbidity, and medication) were recorded from medical reports to confirm
      diagnosis.

      Study power and sample size Sample size was predestined before conducting the study by
      G*POWER statistical software (Franz Faul, Universitat Kiel, Germany; version 3.1.9.2) [F
      tests- ANOVA: Fixed effects, one-way, α=0.05, β=0.2, and large effect size] with the number
      of groups=3, giving a total number of 66 participants to be recruited in this study.

      2.5. Outcome measures The Human Assessment Computer (HUMAC) Balance System, primarily being
      part of a video game appliance (Wii Balance Board), is a distinct technology used in
      assessment and rehabilitation of postural control. It is an affordable, portable and
      prevalent obtainable force plate provides the patient and tester with visual feedback as well
      as numerical data. The system displays several reporting options with objective datum
      providing clinicians with comprehensive case progression which is used for baseline and
      follow-up analysis with eight programs to choose from (HUMAC balance, 2017; Blosch et al.,
      2019). The HUMAC-type technology has been found to detect more imbalances than traditional
      tests (Merchant-Borna et al., 2017). In the current study limits of stability, COP and the
      Clinical Test of Sensory Organization and Balance (CTSIB) were assessed. Each child in the
      three study groups performed three trials and the mean value was estimated for each test.

      2.5.1. Limits of Stability test: Limits of stability are known as the furthest distance a
      subject is capable to shift his/her COP in different directions whilst keeping the
      configuration of the BOS and adjust the body position. This commonly requires the use of a
      force plate that records COP movement and a visual feedback that serves to maximize COP
      displacement in certain directions (Lemay et al., 2014). During this test, the participant is
      instructed to shift the round cursor on the screen (the COP) to the highlighted target. As
      he/she remains in the target for the hold time, this target point is deactivated and should
      move between the center targets to each surrounding target in a random order. A count-up
      timer displays the total test time. He/she must return to the center target after each outer
      target. The test was conducted at two levels 4 and 6. At level 4; this is considered as
      simple test compared with level 6; the distance between center targets to each surrounding
      target is relatively small. On the other hand, at level 6 the distance between center targets
      to each surrounding target is larger.

      2.5.2. Center of pressure test This test is used to measure the variation in a subject's COP
      and displays his/her Right/Left and Anterior/Posterior weight distribution. In the current
      study, the COP test variables recorded were the stability score and path length.

        -  Stability test: It measures the participant's ability to stabilize his/her balance at
           locations around their neutral position. Results are reported as the percent of time a
           subject holds his COP in each of the eight flashing targets in clockwise order
           (right/left and anterior/posterior weight distribution). These targets are eight
           specific points in which the current target flashes green when the participant is
           on-target and flashes yellow when he is off-target. The HUMAC system provides a
           counts-down of the hold time to inform the participant when he/she should move to the
           next target. In addition, the system provides variety of levels based on the distance
           from the center to the farthest target.

        -  Path length: The COP path length represents the COP displacement in which lower values
           indicate better performance (Ju-Hyeong et al., 2020).

      2.5.3. Clinical Test of Sensory Organization and Balance: It is sometimes referred as the
      Romberg or Foam and Dome test. It is used to test how a participant's vestibular,
      somatosensory and visual systems integrate in the conditions of open and closed eyes compared
      to a normal population. The CTSIB protocol typically uses four conditions including eyes
      closed soft surface (ECSS); eyes closed firm surface (ECFS); eyes open soft surface (EOSS);
      Eye open soft surface (EOSS) and eyes open firm surface (EOFS). The participant was
      instructed to stand in a neutral position with the arms at body sides. Each participant went
      through a series of the four tests, which were each 30 seconds long. As participants
      completed the test, the board monitored their COG to determine their stability and path
      length. The requirements of the assessment were clearly demonstrated to all children. The
      assessment procedures were administered following the HUMAC Balance System manual detailed
      instructions. All participants performed three trials of each test, each lasting 30 seconds
      to determine the stability score and path length.
observational model: Cohort
time perspective: Cross-Sectional
measure: limits of stability test
time frame: from January 2018 to January 2020
description: it was measured by the HUMAC. higher scores indicate good balance
measure: center of pressure (COP) test
time frame: from January 2018 to January 2020
description: It was measured by the HUMAC balance system. COP is represented by
path length higher scores indicate poor balance
stability score with higher results indicate good balance
measure: Clinical Test of Sensory Organization and Balance
time frame: from January 2018 to January 2020
description: it was measured by the HUMAc balance system to represent the ability of the child to keep balance while standing on firm and solid surfaces alternatively with eyes open and then eyes closed
arm group label: control group
description: this group included 25 typically developed children
arm group label: on-heamodialysis group
description: this group included children with CKD on-heamodialysis treatment
arm group label: non-dialysis group
description: this group included children with CKD who don't require dialysis
intervention type: Other
intervention name: assessment of postural stability
description: assessment of postural stability
arm group label: control group
arm group label: non-dialysis group
arm group label: on-heamodialysis group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nanees E Mohamed
role: Study Chair
affiliation: Cairo University
last name: Faika S Arab
role: Study Director
affiliation: zagazieg university, Egypt
last name: Nourhan M Baiomy
role: Principal Investigator
affiliation: Cairo university, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Amira Mahmoud Abd-elmonem
investigator title: Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Undecided