xml: <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/NCT05969873</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR &amp; AHS/23/0727</org_study_id>
      <nct_id>NCT05969873</nct_id>
    </id_info>
    <brief_title>Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome</brief_title>
    <official_title>Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <has_dmc>No</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>
        Down's syndrome (DS) is a genetic condition characterized by the presence of an extra&#xD;
        chromosome 21, leading to various clinical symptoms. Individuals with DS often experience&#xD;
        challenges in balance, posture, and motor skills, which can impact their daily activities.&#xD;
        Pilates activities focus on the concept of control of muscles. Pilates increases trunk&#xD;
        flexibility, abdominal and core strength and endurance, and deep core muscle activation hence&#xD;
        improving balance and posture.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be randomized controlled trial used to evaluate the effectiveness of pilates&#xD;
        on posture and balance in children with down's syndrome. Subjects with down's syndrome&#xD;
        meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups&#xD;
        using non-probability sampling technique. Assessment will be done using Pediatric balance&#xD;
        scale(PBS) and Timed up and go test (TUG).). Control group will receive regular physical&#xD;
        therapy with balance training and experimental group will receive regular physical therapy+&#xD;
        Pilates.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 16, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>
      <intervention_model_description>The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pediatric Balance Scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>This tool is used for assessing change from baseline. The PBBS is easy to administer, does not require specialized equipment, and can be completed in &lt;20 minutes. A 0 to 4 grading scale provides a quantitative and qualitative measure of performance. It involves 14 mobility tasks, with the tasks varying in degrees of difficulty. The tasks are divided into 3 domains: sitting balance, standing balance, and dynamic balance. PBS has high validity and reliability of 0.98. 41-56= low fall risk, 21-40= medium fall risk, 0-20=high risk</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Timed up and go test</measure>
      <time_frame>12 weeks</time_frame>
      <description>TUG is a simple test used to assess a person's mobility and evaluate both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turns around 180 degrees, walk back to the chair and sit down while turning 180 degrees.&#xD;
  Interpretation: ≤ 10 seconds= normal. A score of ≥ 14 seconds has been shown to indicate high risk of fall.&#xD;
  ICC value for interrater reliability between 2 authors' TUG times for 20 randomly selected patients was .96.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Down Syndrome</condition>
    <arm_group>
      <arm_group_label>Pilates Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group patients will be treated with physical therapy treatment pilates exercise. Group A underwent 45 minutes of Pilates exercises in addition to the identical exercise programme as group A to improve the strength, coordination and flexibility of the lower limbs. Pilates movements were carried out ten times, with a two-minute break in between each repetition. For six weeks, both groups participated in the intervention programme three times per week. Starting the programme off with supine exercises of segmental motions that include using the trunk muscles to maintain a neutral posture is normal. To enhance shoulder girdle control, supine arm workouts were gradually added. The spine's ability to flex and extend was steadily increased.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Balance training group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group patients will be treated with PT treatment with balance training. Exercises for stability of posture on numerous surfaces and positions were performed by Group B, including exercises for the flexors and adductors of hip, flexors and extensors of knee, and calf muscle (15-second hold and five repetitions) for improving their flexibility. The lower extremity and trunk muscles were the focus of Group B. The postural control exercise included walking in every direction, moving past the point of stability in various postures like half-kneeling, standing on hard and soft surfaces, stepping down and up, walking and standing at the same time, and one leg standing with eyes open and closed. Each session started with a 5-minute warm-up and ended with a 5-minute cool-down in between each phase.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pilates exercise</intervention_name>
      <description>Patients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment.</description>
      <arm_group_label>Pilates Group</arm_group_label>
      <other_name>Experimental group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Balance training</intervention_name>
      <description>Patients in this group will be treated with balance training and conventional physical therapy as baseline treatment.</description>
      <arm_group_label>Balance training group</arm_group_label>
      <other_name>Control group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Down's syndrome children with age between 6 and 12 years.&#xD;
  &#xD;
            -  The ability to execute required motor skill proficiency and executive function tests.&#xD;
  &#xD;
            -  The capacity to walk and stand by oneself&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Children who are not able to comprehend commands.&#xD;
  &#xD;
                 -  Associated cardiovascular and orthopedic condition.&#xD;
  &#xD;
                 -  Loss of functional hearing and vision or a related respiratory disease.&#xD;
  &#xD;
                 -  History of traumatic injury&#xD;
  &#xD;
                 -  History of previous surgery&#xD;
  &#xD;
                 -  Inability of parents to understand the procedure and their unwillingness to&#xD;
                    participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rida Khawar Dar, MS*</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Imran Amjad, PhD</last_name>
      <phone>9233224390125</phone>
      <email>imran.amjad@riphah.edu.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Muhammad Asif Javed, MS</last_name>
      <phone>923224209422</phone>
      <email>a.javed@riphah.edu.pk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Riphah International University</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>54000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Imran Amjad, PhD</last_name>
        <phone>9233224390125</phone>
        <email>imran.amjad@riphah.edu.pk</email>
      </contact>
      <contact_backup>
        <last_name>Muhammad Asif Javed, MS</last_name>
        <phone>923224209422</phone>
        <email>a.javed@riphah.edu.pk</email>
      </contact_backup>
      <investigator>
        <last_name>Rida Khawar Dar, MS*</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Abd-Elfattah HM, Galal DOSM, Aly MIE, Aly SM, Elnegamy TE. Effect of Pilates Exercises on Standing, Walking, and Balance in Children With Diplegic Cerebral Palsy. Ann Rehabil Med. 2022 Feb;46(1):45-52. doi: 10.5535/arm.21148. Epub 2022 Feb 28. Erratum In: Ann Rehabil Med. 2022 Apr;46(2):110.</citation>
      <PMID>35272439</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Balance</keyword>
    <keyword>Contrology</keyword>
    <keyword>Down syndrome</keyword>
    <keyword>Pilates</keyword>
    <keyword>Pediatric Balance Scale</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Down Syndrome</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>
  
  
text: 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/NCT05969873
  org study id: REC/RCR & AHS/23/0727
  nct id: NCT05969873
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Down's syndrome (DS) is a genetic condition characterized by the presence of an extra
        chromosome 21, leading to various clinical symptoms. Individuals with DS often experience
        challenges in balance, posture, and motor skills, which can impact their daily activities.
        Pilates activities focus on the concept of control of muscles. Pilates increases trunk
        flexibility, abdominal and core strength and endurance, and deep core muscle activation hence
        improving balance and posture.
  The study will be randomized controlled trial used to evaluate the effectiveness of pilates
        on posture and balance in children with down's syndrome. Subjects with down's syndrome
        meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups
        using non-probability sampling technique. Assessment will be done using Pediatric balance
        scale(PBS) and Timed up and go test (TUG).). Control group will receive regular physical
        therapy with balance training and experimental group will receive regular physical therapy+
        Pilates.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment.
  measure: Pediatric Balance Scale
  time frame: 12 weeks
  description: This tool is used for assessing change from baseline. The PBBS is easy to administer, does not require specialized equipment, and can be completed in <20 minutes. A 0 to 4 grading scale provides a quantitative and qualitative measure of performance. It involves 14 mobility tasks, with the tasks varying in degrees of difficulty. The tasks are divided into 3 domains: sitting balance, standing balance, and dynamic balance. PBS has high validity and reliability of 0.98. 41-56= low fall risk, 21-40= medium fall risk, 0-20=high risk
  measure: Timed up and go test
  time frame: 12 weeks
  description: TUG is a simple test used to assess a person's mobility and evaluate both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turns around 180 degrees, walk back to the chair and sit down while turning 180 degrees.
  Interpretation: ≤ 10 seconds= normal. A score of ≥ 14 seconds has been shown to indicate high risk of fall.
  ICC value for interrater reliability between 2 authors' TUG times for 20 randomly selected patients was .96.
  arm group label: Pilates Group
  arm group type: Experimental
  description: In this group patients will be treated with physical therapy treatment pilates exercise. Group A underwent 45 minutes of Pilates exercises in addition to the identical exercise programme as group A to improve the strength, coordination and flexibility of the lower limbs. Pilates movements were carried out ten times, with a two-minute break in between each repetition. For six weeks, both groups participated in the intervention programme three times per week. Starting the programme off with supine exercises of segmental motions that include using the trunk muscles to maintain a neutral posture is normal. To enhance shoulder girdle control, supine arm workouts were gradually added. The spine's ability to flex and extend was steadily increased.
  arm group label: Balance training group
  arm group type: Active Comparator
  description: In this group patients will be treated with PT treatment with balance training. Exercises for stability of posture on numerous surfaces and positions were performed by Group B, including exercises for the flexors and adductors of hip, flexors and extensors of knee, and calf muscle (15-second hold and five repetitions) for improving their flexibility. The lower extremity and trunk muscles were the focus of Group B. The postural control exercise included walking in every direction, moving past the point of stability in various postures like half-kneeling, standing on hard and soft surfaces, stepping down and up, walking and standing at the same time, and one leg standing with eyes open and closed. Each session started with a 5-minute warm-up and ended with a 5-minute cool-down in between each phase.
  intervention type: Other
  intervention name: Pilates exercise
  description: Patients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment.
  arm group label: Pilates Group
  other name: Experimental group
  intervention type: Other
  intervention name: Balance training
  description: Patients in this group will be treated with balance training and conventional physical therapy as baseline treatment.
  arm group label: Balance training group
  other name: Control group
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Rida Khawar Dar, MS*
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Imran Amjad, PhD
  phone: 9233224390125
  email: imran.amjad@riphah.edu.pk
  last name: Muhammad Asif Javed, MS
  phone: 923224209422
  email: a.javed@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  citation: Abd-Elfattah HM, Galal DOSM, Aly MIE, Aly SM, Elnegamy TE. Effect of Pilates Exercises on Standing, Walking, and Balance in Children With Diplegic Cerebral Palsy. Ann Rehabil Med. 2022 Feb;46(1):45-52. doi: 10.5535/arm.21148. Epub 2022 Feb 28. Erratum In: Ann Rehabil Med. 2022 Apr;46(2):110.
  PMID: 35272439
  responsible party type: Sponsor
  mesh term: Down Syndrome
  mesh term: Syndrome
  sharing ipd: No