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/NCT06037044</url>
    </required_header>
    <id_info>
      <org_study_id>IRB log #22-0364</org_study_id>
      <nct_id>NCT06037044</nct_id>
    </id_info>
    <brief_title>The Effect of Sensory Integration Balance Training on Children With ABI</brief_title>
    <acronym>ABI</acronym>
    <official_title>The Effect of Sensory Integration Balance Training Compared With Traditional Balance Training for Children With Acquired Brain Injury (ABI)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Princess Nourah Bint Abdulrahman University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Princess Nourah Bint Abdulrahman 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>
        This study aim to investagte the effectivness of sensory integartion balance training during&#xD;
        gait training with obstecles and stimulation to different sensation, in comparission to gait&#xD;
        training with obstecles without sensory stimulation among children with acuired brain injury&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 6, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>
      <masking_description>Assessor will be blinded to group allocation</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pediatric balance scale (PBS)</measure>
      <time_frame>One week before and after training then one month after training</time_frame>
      <description>It was developed as a balance measure for children. The PBS measure can be performed without specialized equipment and is quickly and easily administered. The PBS has been used to measure the functional balance skills for school-age children with mild-to-moderate motor impairments. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. These items include moving from a seated to a standing position, moving from a standing position to a sitting position, transfer, standing without support, sitting without support, standing with eyes closed, standing with feet together, standing with one foot in front of the other, standing on one foot, rotating 360 degrees, turning to look back, picking up an object off the floor, placing alternate foot on step or footrest, and reaching forward with an extended arm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gross motor functional measure (GMFM)</measure>
      <time_frame>One week before and after training then one month after training</time_frame>
      <description>It is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. It has 88 items to explore motor ability in five dimensions; lying and rolling, sitting, crawling and kneeling, standing, and walking, running and jumping</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed up and go (TUG)</measure>
      <time_frame>One week before and after training then one month after training</time_frame>
      <description>It is a simple evaluative test used to measure functional mobility and show how safely a patient can move around. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down while timing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Obstacle Test</measure>
      <time_frame>One week before and after training then one month after training</time_frame>
      <description>It is a timed walking test. Time is calculated while the child is walking stepping over two obstacles and walking around a basket. The pathway is 8.5 meter and the start and end lines are marked. Time is calculating as the child walking between the lines and accomplishing the obstacles. Hight of the obstacle is 15% of the child leg length, while the width is 10%. The basket was around 56 centimeters in width and 69.5 centimeters in length. The child should stand behind the start line and walk in a straight line then step over the obstacles, walk around one side of the basket then pass the end line.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Pediatric Quality of Life Inventory (PedsQL)</measure>
      <time_frame>one week before and after training then one month after training</time_frame>
      <description>It is a brief measure of health-related quality of life in children and young people. The measure is either Proxy Report or Self-Report. It has 23 items comprise four Generic Core Scales: physical functioning, emotional functioning, social functioning, school functioning.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One min sit to stand test (1-MSTST)</measure>
      <time_frame>one week before and after training then one month after training</time_frame>
      <description>The 1-MSTST typically involves an armless chair and the performance of as many sit-to-stand actions as possible in 1 min without using the upper limbs</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Children With Acquired Brain Injury</condition>
    <arm_group>
      <arm_group_label>Sensory integration therapy for balance and gait</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sensory integration walking pathway with obstacles x 10 and standing on one leg with eyes open and eyes closed 5-10 sec</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Traditional Physiotherapy for balance and gait</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Walking pathway with obstacles x 10 and standing on one leg with eyes open 5-10 sec</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sensory integration therapy for balance and gait training</intervention_name>
      <description>Sensory integartion Walking pathway with obstacles x10 rep, standing on one leg with eyes op5-10 sec x10 rep)</description>
      <arm_group_label>Sensory integration therapy for balance and gait</arm_group_label>
      <arm_group_label>Traditional Physiotherapy for balance and gait</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional Physiotherapy for balance and gait training</intervention_name>
      <description>Traditional Physiotherapy walking pathway with obstacles x10 rep, standing on one leg with eyes open 5-10 sec x10 rep</description>
      <arm_group_label>Sensory integration therapy for balance and gait</arm_group_label>
      <arm_group_label>Traditional Physiotherapy for balance and gait</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children with ABI, able to walk with or without assistance, GMFCS level I-III, aged&#xD;
               4-12 years old, with subjective symptoms of balance impairments, fear of falling&#xD;
               and/or history of falls&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Botox injections or tendon release surgery in the past six months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>King abdullah bin abdulaziz university hospital</name>
        <address>
          <city>Riyadh</city>
          <country>Saudi Arabia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Saudi Arabia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Princess Nourah Bint Abdulrahman University</investigator_affiliation>
      <investigator_full_name>Afrah Almuwais</investigator_full_name>
      <investigator_title>Assistant prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
    </condition_browse>
    <!-- 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/NCT06037044
  org study id: IRB log #22-0364
  nct id: NCT06037044
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aim to investagte the effectivness of sensory integartion balance training during
        gait training with obstecles and stimulation to different sensation, in comparission to gait
        training with obstecles without sensory stimulation among children with acuired brain injury
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Assessor will be blinded to group allocation
  measure: Pediatric balance scale (PBS)
  time frame: One week before and after training then one month after training
  description: It was developed as a balance measure for children. The PBS measure can be performed without specialized equipment and is quickly and easily administered. The PBS has been used to measure the functional balance skills for school-age children with mild-to-moderate motor impairments. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. These items include moving from a seated to a standing position, moving from a standing position to a sitting position, transfer, standing without support, sitting without support, standing with eyes closed, standing with feet together, standing with one foot in front of the other, standing on one foot, rotating 360 degrees, turning to look back, picking up an object off the floor, placing alternate foot on step or footrest, and reaching forward with an extended arm.
  measure: Gross motor functional measure (GMFM)
  time frame: One week before and after training then one month after training
  description: It is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. It has 88 items to explore motor ability in five dimensions; lying and rolling, sitting, crawling and kneeling, standing, and walking, running and jumping
  measure: Timed up and go (TUG)
  time frame: One week before and after training then one month after training
  description: It is a simple evaluative test used to measure functional mobility and show how safely a patient can move around. The test requires a subject to stand up, walk 3 m (10 ft), turn, walk back, and sit down while timing.
  measure: Obstacle Test
  time frame: One week before and after training then one month after training
  description: It is a timed walking test. Time is calculated while the child is walking stepping over two obstacles and walking around a basket. The pathway is 8.5 meter and the start and end lines are marked. Time is calculating as the child walking between the lines and accomplishing the obstacles. Hight of the obstacle is 15% of the child leg length, while the width is 10%. The basket was around 56 centimeters in width and 69.5 centimeters in length. The child should stand behind the start line and walk in a straight line then step over the obstacles, walk around one side of the basket then pass the end line.
  measure: The Pediatric Quality of Life Inventory (PedsQL)
  time frame: one week before and after training then one month after training
  description: It is a brief measure of health-related quality of life in children and young people. The measure is either Proxy Report or Self-Report. It has 23 items comprise four Generic Core Scales: physical functioning, emotional functioning, social functioning, school functioning.
  measure: One min sit to stand test (1-MSTST)
  time frame: one week before and after training then one month after training
  description: The 1-MSTST typically involves an armless chair and the performance of as many sit-to-stand actions as possible in 1 min without using the upper limbs
  arm group label: Sensory integration therapy for balance and gait
  arm group type: Experimental
  description: Sensory integration walking pathway with obstacles x 10 and standing on one leg with eyes open and eyes closed 5-10 sec
  arm group label: Traditional Physiotherapy for balance and gait
  arm group type: Active Comparator
  description: Walking pathway with obstacles x 10 and standing on one leg with eyes open 5-10 sec
  intervention type: Other
  intervention name: Sensory integration therapy for balance and gait training
  description: Sensory integartion Walking pathway with obstacles x10 rep, standing on one leg with eyes op5-10 sec x10 rep)
  arm group label: Sensory integration therapy for balance and gait
  arm group label: Traditional Physiotherapy for balance and gait
  intervention type: Other
  intervention name: Traditional Physiotherapy for balance and gait training
  description: Traditional Physiotherapy walking pathway with obstacles x10 rep, standing on one leg with eyes open 5-10 sec x10 rep
  arm group label: Sensory integration therapy for balance and gait
  arm group label: Traditional Physiotherapy for balance and gait
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 12 Years
  healthy volunteers: No
  facility: 
  country: Saudi Arabia
  responsible party type: Principal Investigator
  investigator affiliation: Princess Nourah Bint Abdulrahman University
  investigator full name: Afrah Almuwais
  investigator title: Assistant prof
  mesh term: Brain Injuries