<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/NCT04497103</url>
  </required_header>
  <id_info>
    <org_study_id>2694PT</org_study_id>
    <nct_id>NCT04497103</nct_id>
  </id_info>
  <brief_title>Effect of Task Oriented Training and Xbox KinectTM on Hand Function in Pediatric Burn</brief_title>
  <acronym>HandBurn</acronym>
  <official_title>Effect of Task Oriented Training and Xbox KinectTM on Hand Function in Pediatric Burn</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qassim University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Qassim 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>
      The Jebsen-Taylor Hand Function Test and Canadian Occupational Performance Measure (COPM)&#xD;
      were considered as primary outcome measurements. Secondary outcomes included total active&#xD;
      range of motion (ROM) of the digits, hand grip strength and pinch strengths (tip, palmer and&#xD;
      lateral pinch). All measurement was conducted at two occasions: at the baseline and after&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The included participant were children with a deep partial thickness or a full thickness burn&#xD;
      induced by either a scaled or a flame thermal burn with involvement of more than 50% of the&#xD;
      hand and wrist, total body surface area (TBSA) less than 30% , age ranged from 7 to 14 years,&#xD;
      recent discharge of inpatient acute care, spontaneous healing (within 34 weeks) or grafting&#xD;
      with split thickness or full-thickness skin grafts (at least before 2 weeks). Children were&#xD;
      excluded from this study if they had infection, juvenile arthritis, fracture, tendon&#xD;
      injuries, muscle injury, degenerative joint diseases, peripheral nerve diseases, Pre -&#xD;
      established psychologically and physically disorders (extreme aphasia, cognitive and&#xD;
      developmental deficits that can influence the rehabilitation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">September 20, 2019</completion_date>
  <primary_completion_date type="Actual">September 20, 2019</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Task-oriented training TOT group and Xbox training group were conducted with an average of 50-min sessions three times a week for 8 weeks.&#xD;
The traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Jebsen-Taylor Hand Function Test</measure>
    <time_frame>baseline</time_frame>
    <description>is an objective and standard method designed to assess the hand's functional abilities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Jebsen-Taylor Hand Function Test</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>is an objective and standard method designed to assess the hand's functional abilities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duruoz Hand Index</measure>
    <time_frame>baseline</time_frame>
    <description>is a self-reported questionnaire developed to assess hand ability in the kitchen, during dressing, while performing personal hygiene and office tasks, and other general items</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duruoz Hand Index</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>is a self-reported questionnaire developed to assess hand ability in the kitchen, during dressing, while performing personal hygiene and office tasks, and other general items</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Canadian Occupational Performance Measure</measure>
    <time_frame>baseline</time_frame>
    <description>is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Canadian Occupational Performance Measure</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total active range of motion (ROM) of the digits</measure>
    <time_frame>baseline</time_frame>
    <description>The total active ROM was measured by a hand-held steel finger goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total active range of motion (ROM) of the digits</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>The total active ROM was measured by a hand-held steel finger goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hand grip strength</measure>
    <time_frame>baseline</time_frame>
    <description>Grip strength was assessed using a Jamar hydraulic dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hand grip strength</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>Grip strength was assessed using a Jamar hydraulic dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pinch strength</measure>
    <time_frame>baseline</time_frame>
    <description>pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pinch strength</measure>
    <time_frame>immediately after the intervention</time_frame>
    <description>pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Burns</condition>
  <condition>Hand Burn</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>task oriented training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Task-oriented training TOT group was conducted with an average of 50-min sessions three times a week for 8 weeks. Baseline Canadian Occupational Performance Measure COPM results were used to generate individualized intervention goals for each participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xbox kinect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Xbox training group was conducted with an average of 50-min sessions three times a week for 8 weeks. Baseline Canadian Occupational Performance Measure COPM results were used to generate individualized intervention goals for each participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control</intervention_name>
    <description>The traditional therapy included immersing the hand in paraffin for 10 min; soft massaging with a moisturizing gel for 5 min; passive mobilization of the wrist, MP, PIP, and DIP joints; active/passive ROM and stretching exercises; strengthening exercises (done in static mode initially and progressed in the second month to dynamic strengthening using elastic bands); desensitizing sensory stimulation of hypertrophic scars, occupational therapy.</description>
    <arm_group_label>Xbox kinect</arm_group_label>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>task oriented training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Xbox kinect</intervention_name>
    <description>The traditional plus Xbox Kinect games were related to five target activities determined according to the person-centered analysis results were chosen for each patient.</description>
    <arm_group_label>Xbox kinect</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>task oriented training</intervention_name>
    <description>The traditional plus the target activities involved training with the materials (clothes, spoons, pencils, buttons, rope, etc) needed for the activity as well as Velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools.</description>
    <arm_group_label>task oriented training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with deep partial thickness or a full thickness burn&#xD;
&#xD;
          -  burn induced by either a scaled or a flame thermal burn&#xD;
&#xD;
          -  involvement of more than 50% of the hand and wrist&#xD;
&#xD;
          -  total body surface area (TBSA) less than 30%&#xD;
&#xD;
          -  age ranged from 7 to 14 years&#xD;
&#xD;
          -  recent discharge of inpatient acute care&#xD;
&#xD;
          -  spontaneous healing (within 34 weeks)&#xD;
&#xD;
          -  grafting with split thickness or full-thickness skin grafts (at least before 2 weeks).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with infection&#xD;
&#xD;
          -  juvenile arthritis&#xD;
&#xD;
          -  fracture&#xD;
&#xD;
          -  tendon injuries&#xD;
&#xD;
          -  muscle injury&#xD;
&#xD;
          -  degenerative joint diseases&#xD;
&#xD;
          -  peripheral nerve diseases&#xD;
&#xD;
          -  Pre - established psychologically and physically disorders&#xD;
&#xD;
          -  extreme aphasia&#xD;
&#xD;
          -  cognitive and developmental deficits that can influence the rehabilitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maged Basha, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qassim University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shorook Physical Therapy Centers</name>
      <address>
        <city>Cairo</city>
        <zip>11241</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Parry I, Painting L, Bagley A, Kawada J, Molitor F, Sen S, Greenhalgh DG, Palmieri TL. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up. J Burn Care Res. 2015 Sep-Oct;36(5):534-44. doi: 10.1097/BCR.0000000000000165.</citation>
    <PMID>26335108</PMID>
  </results_reference>
  <results_reference>
    <citation>Voon K, Silberstein I, Eranki A, Phillips M, Wood FM, Edgar DW. Xbox Kinect based rehabilitation as a feasible adjunct for minor upper limb burns rehabilitation: A pilot RCT. Burns. 2016 Dec;42(8):1797-1804. doi: 10.1016/j.burns.2016.06.007. Epub 2016 Jul 9.</citation>
    <PMID>27402183</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Qassim University</investigator_affiliation>
    <investigator_full_name>Maged Basha</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah.</investigator_title>
  </responsible_party>
  <keyword>children burns</keyword>
  <keyword>Hand Function</keyword>
  <keyword>Grip strength</keyword>
  <keyword>pinch strength</keyword>
  <keyword>Jebsen-Taylor Hand Function Test</keyword>
  <keyword>Duruoz Hand Index</keyword>
  <keyword>Canadian Occupational Performance Measure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after de-identification (text, tables,and figures)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Immediately following publication.</ipd_time_frame>
    <ipd_access_criteria>IPD will be available upon reasonable request by email from the main author after revising the requester qualification relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.</ipd_access_criteria>
  </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/NCT04497103
org study id: 2694PT
nct id: NCT04497103
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Jebsen-Taylor Hand Function Test and Canadian Occupational Performance Measure (COPM)
      were considered as primary outcome measurements. Secondary outcomes included total active
      range of motion (ROM) of the digits, hand grip strength and pinch strengths (tip, palmer and
      lateral pinch). All measurement was conducted at two occasions: at the baseline and after
      intervention.
The included participant were children with a deep partial thickness or a full thickness burn
      induced by either a scaled or a flame thermal burn with involvement of more than 50% of the
      hand and wrist, total body surface area (TBSA) less than 30% , age ranged from 7 to 14 years,
      recent discharge of inpatient acute care, spontaneous healing (within 34 weeks) or grafting
      with split thickness or full-thickness skin grafts (at least before 2 weeks). Children were
      excluded from this study if they had infection, juvenile arthritis, fracture, tendon
      injuries, muscle injury, degenerative joint diseases, peripheral nerve diseases, Pre -
      established psychologically and physically disorders (extreme aphasia, cognitive and
      developmental deficits that can influence the rehabilitation).
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Task-oriented training TOT group and Xbox training group were conducted with an average of 50-min sessions three times a week for 8 weeks.
The traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Jebsen-Taylor Hand Function Test
time frame: baseline
description: is an objective and standard method designed to assess the hand's functional abilities
measure: Jebsen-Taylor Hand Function Test
time frame: immediately after the intervention
description: is an objective and standard method designed to assess the hand's functional abilities
measure: Duruoz Hand Index
time frame: baseline
description: is a self-reported questionnaire developed to assess hand ability in the kitchen, during dressing, while performing personal hygiene and office tasks, and other general items
measure: Duruoz Hand Index
time frame: immediately after the intervention
description: is a self-reported questionnaire developed to assess hand ability in the kitchen, during dressing, while performing personal hygiene and office tasks, and other general items
measure: Canadian Occupational Performance Measure
time frame: baseline
description: is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.
measure: Canadian Occupational Performance Measure
time frame: immediately after the intervention
description: is a client centered, occupation-focused outcome measure for the detection of change in perceived occupational performance over time.
measure: total active range of motion (ROM) of the digits
time frame: baseline
description: The total active ROM was measured by a hand-held steel finger goniometer
measure: total active range of motion (ROM) of the digits
time frame: immediately after the intervention
description: The total active ROM was measured by a hand-held steel finger goniometer
measure: hand grip strength
time frame: baseline
description: Grip strength was assessed using a Jamar hydraulic dynamometer
measure: hand grip strength
time frame: immediately after the intervention
description: Grip strength was assessed using a Jamar hydraulic dynamometer
measure: pinch strength
time frame: baseline
description: pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer
measure: pinch strength
time frame: immediately after the intervention
description: pinch strengths (tip, palmer and lateral pinch) were assessed using a pinch dynamometer
arm group label: control
arm group type: Active Comparator
description: The traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.
arm group label: task oriented training
arm group type: Experimental
description: Task-oriented training TOT group was conducted with an average of 50-min sessions three times a week for 8 weeks. Baseline Canadian Occupational Performance Measure COPM results were used to generate individualized intervention goals for each participant.
arm group label: Xbox kinect
arm group type: Experimental
description: Xbox training group was conducted with an average of 50-min sessions three times a week for 8 weeks. Baseline Canadian Occupational Performance Measure COPM results were used to generate individualized intervention goals for each participant.
intervention type: Other
intervention name: control
description: The traditional therapy included immersing the hand in paraffin for 10 min; soft massaging with a moisturizing gel for 5 min; passive mobilization of the wrist, MP, PIP, and DIP joints; active/passive ROM and stretching exercises; strengthening exercises (done in static mode initially and progressed in the second month to dynamic strengthening using elastic bands); desensitizing sensory stimulation of hypertrophic scars, occupational therapy.
arm group label: Xbox kinect
arm group label: control
arm group label: task oriented training
intervention type: Other
intervention name: Xbox kinect
description: The traditional plus Xbox Kinect games were related to five target activities determined according to the person-centered analysis results were chosen for each patient.
arm group label: Xbox kinect
intervention type: Other
intervention name: task oriented training
description: The traditional plus the target activities involved training with the materials (clothes, spoons, pencils, buttons, rope, etc) needed for the activity as well as Velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools.
arm group label: task oriented training
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: No
last name: Maged Basha, PhD
role: Principal Investigator
affiliation: Qassim University
facility: 
country: Egypt
citation: Parry I, Painting L, Bagley A, Kawada J, Molitor F, Sen S, Greenhalgh DG, Palmieri TL. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up. J Burn Care Res. 2015 Sep-Oct;36(5):534-44. doi: 10.1097/BCR.0000000000000165.
PMID: 26335108
citation: Voon K, Silberstein I, Eranki A, Phillips M, Wood FM, Edgar DW. Xbox Kinect based rehabilitation as a feasible adjunct for minor upper limb burns rehabilitation: A pilot RCT. Burns. 2016 Dec;42(8):1797-1804. doi: 10.1016/j.burns.2016.06.007. Epub 2016 Jul 9.
PMID: 27402183
responsible party type: Principal Investigator
investigator affiliation: Qassim University
investigator full name: Maged Basha
investigator title: Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah.
mesh term: Burns
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables,and figures)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Immediately following publication.
ipd access criteria: IPD will be available upon reasonable request by email from the main author after revising the requester qualification relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.