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/NCT05992207</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/ 012/004454</org_study_id>
      <nct_id>NCT05992207</nct_id>
    </id_info>
    <brief_title>Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children After Medulloblastoma Resection</brief_title>
    <official_title>Motor Imagery Training for Improvement of Balance of Ataxic Children</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: after resection of medulloblastoma in children they suffer from signs and&#xD;
        symptoms of ataxia which impedes their activities of daily living. purpose: to investigate&#xD;
        the effect motor imagery training on balance, severity of ataxia and gait parameters on&#xD;
        children after resection of medulloblastoma. Methods: Fifty children surfing from cerebellar&#xD;
        ataxia after medulloblastoma resection were selected from tumors hospital of Cairo&#xD;
        University, their age ranged from seven to nine years old, they were randomly assigned into&#xD;
        two matched control and study groups. The control groups received the selected physical&#xD;
        therapy program while, the study group received motor imaginary training in addition to the&#xD;
        selected physical therapy program. Both groups were evaluated by ataxic rating scale,&#xD;
        pediatric berg balance scale and kinematic gait analysis by kinovea software.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Motor imagery is an effective method to enhance motor performance applied in rehabilitation&#xD;
        programs it did not impose a physical load on patients, was confirmed through clinical&#xD;
        evidence from meta#analysis. Motor imagery means thinking in motor task with executing it to&#xD;
        activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by&#xD;
        thinking.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 21, 2023</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">May 18, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Severity of ataxia</measure>
      <time_frame>3 months</time_frame>
      <description>The SARA determines the degree of ataxia. It has eight items with a score range of 0 (means no ataxia) to 40 (means severe ataxia). It contains sitting, stance, gait, limb kinetic functions, heel-shin slide, fast alternating hand movements, nose-finger test, finger chase, and speech disturbance. The arithmetic means of the left and right sides and independent ratings of each side are included in the SARA total score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pediatric berg balance scale</measure>
      <time_frame>3 months</time_frame>
      <description>The Paediatric Berg Balance Scale assesses children's balance. The scale includes 14 items: sit to stand, stand to sit, transfers, stand unsupported, sit unsupported, stand with eyes closed, stand with feet together, stand with one foot in front of the other, stand on one foot, turn 360 degrees, turn to look behind, retrieve an object from the floor, place an alternating foot on a stool, and reach forward with an outstretched arm. The total scale score ranges from zero to 56.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Kinematic gait assessment</measure>
      <time_frame>3 months</time_frame>
      <description>Kinematic gait analysis measured temporospatial gait variables using a two-dimensional motion analysis system. Markers were placed on the skin overlying the lateral femoral epicondyle, greater trochanter, 5th metatarsal head, and lateral malleolus. The therapist set a tripod with a fixed video camera at 3 m from the walkway. The fixed video camera was concentrated on the central part to record three gait cycles in the sagittal plane. The therapist used the Kinovea software (version 8.15.0) to measure stride length, step length, cadence, and walking speed. The measurement involved one walking trial at the chosen speed throughout the 4-m walkway.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Cerebellar Ataxia</condition>
    <arm_group>
      <arm_group_label>physical thertapy training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The Control group received the selected physical therapy program for one hour, three times weekly for three successive months including facilitation of balance and protective reactions from standing position, standing on one leg, weight shifting from standing, squat to standing, strengthening exercises for trunk muscles and for upper and lower extremities musculatures, gait training activities for correction of gait pattern</description>
    </arm_group>
    <arm_group>
      <arm_group_label>motor imaginary training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The study group received the selected physical therapy program for one hour, three times weekly for three successive months in addition to motor imagery program for 30 minutes as the following. Each child shown a video of 5 minutes of illustrating normal movements while the child resting in semireclined sitting in quiet room in front the screen. Children then asked to close their eyes and imagine practicing the task like the illustrative video. Repetition of the exercises depend on the children ranging from 5 to 10 repetitions per exercise</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>motor imaginary training</intervention_name>
      <description>Each child shown a video of 5 minutes of illustrating normal movements while the child resting in semi#reclined sitting in quiet room in front the screen. Children then asked to close their eyes and imagine practicing the task like the illustrative video. Repetition of the exercises depend on the children ranging from 5 to 10 repetitions per exercise.</description>
      <arm_group_label>motor imaginary training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physical therapy training</intervention_name>
      <description>facilitation of balance and protective reactions from standing position, standing on one leg, weight shifting from standing, squat to standing, strengthening exercises for trunk muscles and for upper and lower extremities musculatures, gait training activities for correction of gait pattern</description>
      <arm_group_label>physical thertapy training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The children had signs of ataxia&#xD;
  &#xD;
            -  loss of balance&#xD;
  &#xD;
            -  able to understand and execute test instructions&#xD;
  &#xD;
            -  the children are in the follow up period after medulloblastoma resection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  medically unstable&#xD;
  &#xD;
            -  visual impairment&#xD;
  &#xD;
            -  increased intracranial pressure&#xD;
  &#xD;
            -  any other neuromuscular diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>9 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Reham Alsakhawi</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Reham Alsakhawi</name>
        <address>
          <city>Giza</city>
          <zip>11236</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Reham Saeed Alsakhawi</investigator_full_name>
      <investigator_title>Assisstant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ataxia</mesh_term>
      <mesh_term>Cerebellar Ataxia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>data from participants will be made available</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>12 months after study completion</ipd_time_frame>
      <ipd_access_criteria>data access requests will be reviewed by an external independent review panel. requestor will be required to sign a data access agreement</ipd_access_criteria>
    </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/NCT05992207
  org study id: P.T.REC/ 012/004454
  nct id: NCT05992207
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Background: after resection of medulloblastoma in children they suffer from signs and
        symptoms of ataxia which impedes their activities of daily living. purpose: to investigate
        the effect motor imagery training on balance, severity of ataxia and gait parameters on
        children after resection of medulloblastoma. Methods: Fifty children surfing from cerebellar
        ataxia after medulloblastoma resection were selected from tumors hospital of Cairo
        University, their age ranged from seven to nine years old, they were randomly assigned into
        two matched control and study groups. The control groups received the selected physical
        therapy program while, the study group received motor imaginary training in addition to the
        selected physical therapy program. Both groups were evaluated by ataxic rating scale,
        pediatric berg balance scale and kinematic gait analysis by kinovea software.
  Motor imagery is an effective method to enhance motor performance applied in rehabilitation
        programs it did not impose a physical load on patients, was confirmed through clinical
        evidence from meta#analysis. Motor imagery means thinking in motor task with executing it to
        activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by
        thinking.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Severity of ataxia
  time frame: 3 months
  description: The SARA determines the degree of ataxia. It has eight items with a score range of 0 (means no ataxia) to 40 (means severe ataxia). It contains sitting, stance, gait, limb kinetic functions, heel-shin slide, fast alternating hand movements, nose-finger test, finger chase, and speech disturbance. The arithmetic means of the left and right sides and independent ratings of each side are included in the SARA total score.
  measure: Pediatric berg balance scale
  time frame: 3 months
  description: The Paediatric Berg Balance Scale assesses children's balance. The scale includes 14 items: sit to stand, stand to sit, transfers, stand unsupported, sit unsupported, stand with eyes closed, stand with feet together, stand with one foot in front of the other, stand on one foot, turn 360 degrees, turn to look behind, retrieve an object from the floor, place an alternating foot on a stool, and reach forward with an outstretched arm. The total scale score ranges from zero to 56.
  measure: Kinematic gait assessment
  time frame: 3 months
  description: Kinematic gait analysis measured temporospatial gait variables using a two-dimensional motion analysis system. Markers were placed on the skin overlying the lateral femoral epicondyle, greater trochanter, 5th metatarsal head, and lateral malleolus. The therapist set a tripod with a fixed video camera at 3 m from the walkway. The fixed video camera was concentrated on the central part to record three gait cycles in the sagittal plane. The therapist used the Kinovea software (version 8.15.0) to measure stride length, step length, cadence, and walking speed. The measurement involved one walking trial at the chosen speed throughout the 4-m walkway.
  arm group label: physical thertapy training
  arm group type: Active Comparator
  description: The Control group received the selected physical therapy program for one hour, three times weekly for three successive months including facilitation of balance and protective reactions from standing position, standing on one leg, weight shifting from standing, squat to standing, strengthening exercises for trunk muscles and for upper and lower extremities musculatures, gait training activities for correction of gait pattern
  arm group label: motor imaginary training
  arm group type: Active Comparator
  description: The study group received the selected physical therapy program for one hour, three times weekly for three successive months in addition to motor imagery program for 30 minutes as the following. Each child shown a video of 5 minutes of illustrating normal movements while the child resting in semireclined sitting in quiet room in front the screen. Children then asked to close their eyes and imagine practicing the task like the illustrative video. Repetition of the exercises depend on the children ranging from 5 to 10 repetitions per exercise
  intervention type: Other
  intervention name: motor imaginary training
  description: Each child shown a video of 5 minutes of illustrating normal movements while the child resting in semi#reclined sitting in quiet room in front the screen. Children then asked to close their eyes and imagine practicing the task like the illustrative video. Repetition of the exercises depend on the children ranging from 5 to 10 repetitions per exercise.
  arm group label: motor imaginary training
  intervention type: Other
  intervention name: physical therapy training
  description: facilitation of balance and protective reactions from standing position, standing on one leg, weight shifting from standing, squat to standing, strengthening exercises for trunk muscles and for upper and lower extremities musculatures, gait training activities for correction of gait pattern
  arm group label: physical thertapy training
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 9 Years
  healthy volunteers: No
  last name: Reham Alsakhawi
  role: Principal Investigator
  affiliation: Cairo University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Reham Saeed Alsakhawi
  investigator title: Assisstant Professor
  mesh term: Ataxia
  mesh term: Cerebellar Ataxia
  sharing ipd: Yes
  ipd description: data from participants will be made available
  ipd info type: Study Protocol
  ipd time frame: 12 months after study completion
  ipd access criteria: data access requests will be reviewed by an external independent review panel. requestor will be required to sign a data access agreement