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/NCT06011616</url>
    </required_header>
    <id_info>
      <org_study_id>RIPHAH/FR&amp;AHS/Letter-014194</org_study_id>
      <nct_id>NCT06011616</nct_id>
    </id_info>
    <brief_title>Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy</brief_title>
    <official_title>Effects of Upperlimb Sensorimotor Training in Hemiplegic Cerebral Palsy</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>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>
        The study aims to determine the effects of upper limb sensorimotor training as compared to&#xD;
        task oriented raining in subjects with cerebral palsy. The study will target the upperlimb&#xD;
        functions using multiple outcomes and will find the changes in subjects undergoing&#xD;
        sensorimotor or task oriented training.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The stduy will include subjects fulfilling the inclusion criteria, will be divided into 2&#xD;
        groups; interventional and control. The interventional group will be recieving sensorimotor&#xD;
        training comprising of sensory activities and motor activities. The control group will be&#xD;
        having motor activities in the form of task oriented training. The duration of intervention&#xD;
        would be 40 minutes in each group, 3 days a week, for 8 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">February 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 20, 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>
      <intervention_model_description>2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Only the subjects would be masked about the group they belong too.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Modified Ashworth Scale (MAS)</measure>
      <time_frame>Baseline</time_frame>
      <description>Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified Ashworth Scale (MAS)</measure>
      <time_frame>After 4 weeks</time_frame>
      <description>Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified Ashworth Scale (MAS)</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Finger Joint Position Sense</measure>
      <time_frame>Baseline</time_frame>
      <description>Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Finger Joint Position Sense</measure>
      <time_frame>After 4 weeks</time_frame>
      <description>Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Finger Joint Position Sense</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Manual ability classification system</measure>
      <time_frame>Baseline</time_frame>
      <description>Manual ability classification system is used to determine daily use hand activities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Manual ability classification system</measure>
      <time_frame>After 4 weeks</time_frame>
      <description>Manual ability classification system is used to determine daily use hand activities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Manual ability classification system</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>Manual ability classification system is used to determine daily use hand activities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Manual Muscle Testing</measure>
      <time_frame>Baseline</time_frame>
      <description>Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Manual Muscle Testing</measure>
      <time_frame>After 4 weeks</time_frame>
      <description>Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Manual Muscle Testing</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Abilities of Hand (ABILHAND-KIDS)</measure>
      <time_frame>Baseline</time_frame>
      <description>This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Abilities of Hand (ABILHAND-KIDS)</measure>
      <time_frame>After 4 weeks</time_frame>
      <description>This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Abilities of Hand (ABILHAND-KIDS)</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pediatric Arm Function Test</measure>
      <time_frame>Baseline</time_frame>
      <description>This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pediatric Arm Function Test</measure>
      <time_frame>After 4 weeks</time_frame>
      <description>This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pediatric Arm Function Test</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>interventional group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Superficial and Deep Sensory training: 5 sets of 9 min, 3 times a week for 8 weeks.&#xD;
  Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sensory training</intervention_name>
      <description>sensory training includes superficial sensory and deep sensory activities i.e. play with dough, painting with finger, recognizing objects with blocked vision, recognizing the drawn figure on palm, oint compression, bearing the weight on the paretic hand, leaning on the paretic side, walking with hand, rolling the heavy objects, dough squeezing etc.</description>
      <arm_group_label>interventional group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Motor training</intervention_name>
      <description>Motor training would involve activitoes such as throwing and catching a ball, targeted ball throwing, hand in hand ball transferring, ball rolling, hitting a ball to ground and wall, hand roller etc.</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>interventional group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional exercises</intervention_name>
      <description>stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>interventional group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Hemiplegic cerebral palsy Modified Ashworth scale score 2 and 3&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other neurological disorders Previous upper limb surgeries Botox injection in last 1&#xD;
               year&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kiran Khushnood, MSNMPT</last_name>
      <role>Study Chair</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kiran Khushnood</last_name>
      <phone>+92 3335993417</phone>
      <email>kiran.khushnood@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Alfarabi Special Education Centre/ Physical Health Centre</name>
        <address>
          <city>Islamabad</city>
          <state>Islamabad Capital Territory</state>
          <zip>44000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Nayab Gohar, DPT</last_name>
        <phone>03349513318</phone>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cerebral Palsy</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/NCT06011616
  org study id: RIPHAH/FR&AHS/Letter-014194
  nct id: NCT06011616
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to determine the effects of upper limb sensorimotor training as compared to
        task oriented raining in subjects with cerebral palsy. The study will target the upperlimb
        functions using multiple outcomes and will find the changes in subjects undergoing
        sensorimotor or task oriented training.
  The stduy will include subjects fulfilling the inclusion criteria, will be divided into 2
        groups; interventional and control. The interventional group will be recieving sensorimotor
        training comprising of sensory activities and motor activities. The control group will be
        having motor activities in the form of task oriented training. The duration of intervention
        would be 40 minutes in each group, 3 days a week, for 8 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 2 group parallel randomized control trial; both groups will be recruited and provided with interventions in parallel
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Only the subjects would be masked about the group they belong too.
  measure: Modified Ashworth Scale (MAS)
  time frame: Baseline
  description: Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
  measure: Modified Ashworth Scale (MAS)
  time frame: After 4 weeks
  description: Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
  measure: Modified Ashworth Scale (MAS)
  time frame: After 8 weeks
  description: Modified Ashworth Scale measures the level of spasticity, ranging from 0-4 with 0 being no increase in tone and 4 being affected parts rigid in flexion
  measure: Finger Joint Position Sense
  time frame: Baseline
  description: Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
  measure: Finger Joint Position Sense
  time frame: After 4 weeks
  description: Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
  measure: Finger Joint Position Sense
  time frame: After 8 weeks
  description: Finger Joint Position Sense is done to determine the sense of position, in whcih the subjet's finger is moved by the outcome assesser with eyes closed.
  measure: Manual ability classification system
  time frame: Baseline
  description: Manual ability classification system is used to determine daily use hand activities
  measure: Manual ability classification system
  time frame: After 4 weeks
  description: Manual ability classification system is used to determine daily use hand activities
  measure: Manual ability classification system
  time frame: After 8 weeks
  description: Manual ability classification system is used to determine daily use hand activities
  measure: Manual Muscle Testing
  time frame: Baseline
  description: Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
  measure: Manual Muscle Testing
  time frame: After 4 weeks
  description: Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
  measure: Manual Muscle Testing
  time frame: After 8 weeks
  description: Manual Muscle Testing is used to determine the strength. the score varies from 0-5; 0 means no contraction and 5 means movement aagainst maximum resistance
  measure: Abilities of Hand (ABILHAND-KIDS)
  time frame: Baseline
  description: This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
  measure: Abilities of Hand (ABILHAND-KIDS)
  time frame: After 4 weeks
  description: This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
  measure: Abilities of Hand (ABILHAND-KIDS)
  time frame: After 8 weeks
  description: This tool is used to determine the hand and manual abilities of the kids. It has 21 manual activites with 3 levels each; 1 as impossible, 2 difficult and 3 easy.
  measure: Pediatric Arm Function Test
  time frame: Baseline
  description: This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
  measure: Pediatric Arm Function Test
  time frame: After 4 weeks
  description: This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
  measure: Pediatric Arm Function Test
  time frame: After 8 weeks
  description: This is used to determine the upper extremity movement patterns in playful situation. It has 26 items with each at 6 levels ranging from minimum to maximum function.
  arm group label: interventional group
  arm group type: Experimental
  description: Superficial and Deep Sensory training: 5 sets of 9 min, 3 times a week for 8 weeks.
  Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks
  arm group label: control group
  arm group type: Active Comparator
  description: Motor training: 5 sets of 9 min, 3 times a week for 8 weeks. Conventional therapy: 30 min, 3 days for 8 weeks
  intervention type: Other
  intervention name: Sensory training
  description: sensory training includes superficial sensory and deep sensory activities i.e. play with dough, painting with finger, recognizing objects with blocked vision, recognizing the drawn figure on palm, oint compression, bearing the weight on the paretic hand, leaning on the paretic side, walking with hand, rolling the heavy objects, dough squeezing etc.
  arm group label: interventional group
  intervention type: Other
  intervention name: Motor training
  description: Motor training would involve activitoes such as throwing and catching a ball, targeted ball throwing, hand in hand ball transferring, ball rolling, hitting a ball to ground and wall, hand roller etc.
  arm group label: control group
  arm group label: interventional group
  intervention type: Other
  intervention name: Conventional exercises
  description: stretching exercises, muscle strengthening exercises, static weight bearing exercises, positioning
  arm group label: control group
  arm group label: interventional group
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Kiran Khushnood, MSNMPT
  role: Study Chair
  affiliation: Riphah International University
  last name: Kiran Khushnood
  phone: +92 3335993417
  email: kiran.khushnood@riphah.edu.pk
  facility: 
  contact: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Cerebral Palsy
  sharing ipd: No