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/NCT05988944</url>
    </required_header>
    <id_info>
      <org_study_id>CIMT vs VR</org_study_id>
      <nct_id>NCT05988944</nct_id>
    </id_info>
    <brief_title>The Hand Functions In Cerebral Palsy</brief_title>
    <official_title>Which One is The Most Effective On The Hand Functions In Cerebral Palsy: Constraint-Induced Movement Therapy or Constraint-Induced Movement Therapy With Virtual Reality? A Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uludag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uludag 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>
        The hand motor functions are very important in the daily life activities, educational, and&#xD;
        social participation of children. Losing The hand motor functions limit these activities and&#xD;
        participation. Constraint-induced movement therapy (CIMT) or virtual reality (VR) therapy has&#xD;
        often been preferred to improve the hand's motor functions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        CIMT and VR are used to improve the motor functions of the hand in cerebral palsy (CP). The&#xD;
        aim of this study was to compare the effects of CIMT-VR use and only CIMT use on hand&#xD;
        functions in children with hemiparetic cerebral palsy. Hand function and performance were&#xD;
        evaluated with the Jebsen-Taylor and Moberg pick-up tests. All evaluations were made twice;&#xD;
        before the first therapy and after six weeks. Children with hemiparetic CP were divided into&#xD;
        three groups randomly (Traditional techniques (TT), TT+CIMT, and TT+CIMT+VR).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">November 17, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 27, 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>The Jebsen-Taylor Test</measure>
      <time_frame>this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.</time_frame>
      <description>The Jebsen-Taylor Test is a reliable tool that evaluates the hand function of children with CP. The test includes seven items. These items are; writing a 24-letter sentence, turning over five cards, picking up small objects (two pieces of pennies/bottle caps/paperclips), simulated feeding (using a teaspoon and five kidney beans), stacking four checkers, picking up and moving five large empty tin boxes and then five large full boxes. During the assessment, the child with CP was seated in front of a table and test was performed by hemiparetic hand. Time was recorded on each item by stopwatch. The total score was calculated by collecting all items' time.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Moberg pick-up test</measure>
      <time_frame>this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.</time_frame>
      <description>To evaluate the functional performance of the hemiparetic hand Moberg pick-up test (MPUT) was used. MPUT consists of twelve items which are a wing nut, screw, key, nail, ₺1 coin, 50 kurus coin, washer, safety pin, paper clip, large and medium-sized hexagonal nut, and small square nut. The plastic container (60x30 cm) was placed lengthwise about 15 cm from the edge of the table on the opposite side of the items. The child was seated in a chair. The hemiparetic hand of children with CP was put on the same side as the 12 items which were randomly placed on the table. Children with CP were ordered to pick up the items one at a time and place them into the plastic container as fast as possible. The time was recorded with a stopwatch.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Cerebral Palsy</condition>
    <condition>Hand Functions</condition>
    <arm_group>
      <arm_group_label>Traditional techniques</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>TT was planned according to the child's hand that was needed. Neurodevelopmental facilitation techniques (Bobath therapy), stretching, and grasping types (cylindrical, spherical, hook, key, fingertip, lateral) were used in hands therapy for 45 minutes two days in a week for all children who were accepted to participate in this study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>traditional therapy with constraint induced movement therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The sling was put on the child's non-paretic arm to apply CIMT. The around of the sling was sewn except the elbow and secured snugly to the trunk with a waist strap to prevent assisting the affected hand during the application of CIMT. However, children with CP who were in the this group used the sling for three hours in daily activity, playing, etc. at home. The CIMT was given as a home program and monitorization was done by the follow-up form every week with no therapy during the weekend.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>traditional therapy with constraint induced movement therapy and virtual reality</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After the TT session, a child with CP used the sling for 45 minutes at the rehabilitation center with VR therapy. VR therapy with CIMT was used in hands therapy for 45 minutes at two days a week after TT. During the VR therapy, the child was encouraged verbally to play X-box.The X-box Kinect 360 (by the Microsoft corporation) was used for VR therapy. It has a kinetic sensor that perceives the movement of the child with CP. The child's movement can be seen through the monitor in real time. VR does not need special buttons to play. Therefore, a child with CP who had impaired fine motor skills and dexterity can play easily.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TT+CIMT+VR</intervention_name>
      <description>TT: Traditional Techniques CIMT: constraint-induced movement therapy VR: virtual reality</description>
      <arm_group_label>traditional therapy with constraint induced movement therapy and virtual reality</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TT+CIMT</intervention_name>
      <description>TT: Traditional Techniques CIMT: constraint-induced movement therapy</description>
      <arm_group_label>traditional therapy with constraint induced movement therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TT</intervention_name>
      <description>TT: Traditional Techniques</description>
      <arm_group_label>Traditional techniques</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The inclusion criteria of the study were determined to be&#xD;
  &#xD;
            -  aged 8 to 18 years,&#xD;
  &#xD;
            -  diagnosed with hemiparetic CP,&#xD;
  &#xD;
            -  being level 2 or 3 according to the gross motor function measurement scale and the&#xD;
               manual ability classification system.&#xD;
  &#xD;
          The exclusion criteria of the study were,&#xD;
  &#xD;
            -  severe cognitive dysfunction that rendered them unable to perform simple tasks (e.g.,&#xD;
               reaching, grasping),&#xD;
  &#xD;
            -  having pharmacologic medicine for spasticity,&#xD;
  &#xD;
            -  having botulinum toxin A injections in the last 6 months,&#xD;
  &#xD;
            -  having upper extremity surgery,&#xD;
  &#xD;
            -  having visual and/or auditory problems which affect therapy or evaluation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Esin KADIKOYLU, Pt</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Eren DEMIRAYAK, Pt</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Cetin Sayaca, Assoc. Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Uludag University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cetin Sayaca, Assoc. Prof.</last_name>
      <phone>+90 543 621 8023</phone>
      <email>cetinsayaca@uludag.edu.tr</email>
    </overall_contact>
    <reference>
      <citation>Elliott C, Reid S, Hamer P, Alderson J, Elliott B. Lycra((R)) arm splints improve movement fluency in children with cerebral palsy. Gait Posture. 2011 Feb;33(2):214-9. doi: 10.1016/j.gaitpost.2010.11.008. Epub 2010 Dec 4.</citation>
      <PMID>21131201</PMID>
    </reference>
    <reference>
      <citation>Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3.</citation>
      <PMID>30932166</PMID>
    </reference>
    <reference>
      <citation>Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.</citation>
      <PMID>19451190</PMID>
    </reference>
    <reference>
      <citation>Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.</citation>
      <PMID>19489088</PMID>
    </reference>
    <reference>
      <citation>Jung SH, Song SH, Kim SD, Lee K, Lee GC. Does virtual reality training using the Xbox Kinect have a positive effect on physical functioning in children with spastic cerebral palsy? A case series. J Pediatr Rehabil Med. 2018;11(2):95-101. doi: 10.3233/PRM-160415.</citation>
      <PMID>30010148</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uludag University</investigator_affiliation>
      <investigator_full_name>Cetin Sayaca</investigator_full_name>
      <investigator_title>Principal Investigator; Assos. Prof.</investigator_title>
    </responsible_party>
    <keyword>Hand Functions</keyword>
    <keyword>Virtual Reality</keyword>
    <keyword>Constraint-Induced Movement Therapy</keyword>
    <keyword>Cerebral Palsy</keyword>
    <keyword>Rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paralysis</mesh_term>
      <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/NCT05988944
  org study id: CIMT vs VR
  nct id: NCT05988944
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The hand motor functions are very important in the daily life activities, educational, and
        social participation of children. Losing The hand motor functions limit these activities and
        participation. Constraint-induced movement therapy (CIMT) or virtual reality (VR) therapy has
        often been preferred to improve the hand's motor functions.
  CIMT and VR are used to improve the motor functions of the hand in cerebral palsy (CP). The
        aim of this study was to compare the effects of CIMT-VR use and only CIMT use on hand
        functions in children with hemiparetic cerebral palsy. Hand function and performance were
        evaluated with the Jebsen-Taylor and Moberg pick-up tests. All evaluations were made twice;
        before the first therapy and after six weeks. Children with hemiparetic CP were divided into
        three groups randomly (Traditional techniques (TT), TT+CIMT, and TT+CIMT+VR).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: The Jebsen-Taylor Test
  time frame: this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.
  description: The Jebsen-Taylor Test is a reliable tool that evaluates the hand function of children with CP. The test includes seven items. These items are; writing a 24-letter sentence, turning over five cards, picking up small objects (two pieces of pennies/bottle caps/paperclips), simulated feeding (using a teaspoon and five kidney beans), stacking four checkers, picking up and moving five large empty tin boxes and then five large full boxes. During the assessment, the child with CP was seated in front of a table and test was performed by hemiparetic hand. Time was recorded on each item by stopwatch. The total score was calculated by collecting all items' time.
  measure: Moberg pick-up test
  time frame: this evaluation was done twice; before the first therapy and after six weeks by the same physiotherapist.
  description: To evaluate the functional performance of the hemiparetic hand Moberg pick-up test (MPUT) was used. MPUT consists of twelve items which are a wing nut, screw, key, nail, ₺1 coin, 50 kurus coin, washer, safety pin, paper clip, large and medium-sized hexagonal nut, and small square nut. The plastic container (60x30 cm) was placed lengthwise about 15 cm from the edge of the table on the opposite side of the items. The child was seated in a chair. The hemiparetic hand of children with CP was put on the same side as the 12 items which were randomly placed on the table. Children with CP were ordered to pick up the items one at a time and place them into the plastic container as fast as possible. The time was recorded with a stopwatch.
  arm group label: Traditional techniques
  arm group type: Active Comparator
  description: TT was planned according to the child's hand that was needed. Neurodevelopmental facilitation techniques (Bobath therapy), stretching, and grasping types (cylindrical, spherical, hook, key, fingertip, lateral) were used in hands therapy for 45 minutes two days in a week for all children who were accepted to participate in this study.
  arm group label: traditional therapy with constraint induced movement therapy
  arm group type: Experimental
  description: The sling was put on the child's non-paretic arm to apply CIMT. The around of the sling was sewn except the elbow and secured snugly to the trunk with a waist strap to prevent assisting the affected hand during the application of CIMT. However, children with CP who were in the this group used the sling for three hours in daily activity, playing, etc. at home. The CIMT was given as a home program and monitorization was done by the follow-up form every week with no therapy during the weekend.
  arm group label: traditional therapy with constraint induced movement therapy and virtual reality
  arm group type: Experimental
  description: After the TT session, a child with CP used the sling for 45 minutes at the rehabilitation center with VR therapy. VR therapy with CIMT was used in hands therapy for 45 minutes at two days a week after TT. During the VR therapy, the child was encouraged verbally to play X-box.The X-box Kinect 360 (by the Microsoft corporation) was used for VR therapy. It has a kinetic sensor that perceives the movement of the child with CP. The child's movement can be seen through the monitor in real time. VR does not need special buttons to play. Therefore, a child with CP who had impaired fine motor skills and dexterity can play easily.
  intervention type: Other
  intervention name: TT+CIMT+VR
  description: TT: Traditional Techniques CIMT: constraint-induced movement therapy VR: virtual reality
  arm group label: traditional therapy with constraint induced movement therapy and virtual reality
  intervention type: Other
  intervention name: TT+CIMT
  description: TT: Traditional Techniques CIMT: constraint-induced movement therapy
  arm group label: traditional therapy with constraint induced movement therapy
  intervention type: Other
  intervention name: TT
  description: TT: Traditional Techniques
  arm group label: Traditional techniques
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Esin KADIKOYLU, Pt
  role: Study Chair
  affiliation: Uskudar University
  last name: Eren DEMIRAYAK, Pt
  role: Study Chair
  affiliation: Uskudar University
  last name: Cetin Sayaca, Assoc. Prof.
  role: Principal Investigator
  affiliation: Uludag University
  last name: Cetin Sayaca, Assoc. Prof.
  phone: +90 543 621 8023
  email: cetinsayaca@uludag.edu.tr
  citation: Elliott C, Reid S, Hamer P, Alderson J, Elliott B. Lycra((R)) arm splints improve movement fluency in children with cerebral palsy. Gait Posture. 2011 Feb;33(2):214-9. doi: 10.1016/j.gaitpost.2010.11.008. Epub 2010 Dec 4.
  PMID: 21131201
  citation: Hoare BJ, Wallen MA, Thorley MN, Jackman ML, Carey LM, Imms C. Constraint-induced movement therapy in children with unilateral cerebral palsy. Cochrane Database Syst Rev. 2019 Apr 1;4(4):CD004149. doi: 10.1002/14651858.CD004149.pub3.
  PMID: 30932166
  citation: Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.
  PMID: 19451190
  citation: Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.
  PMID: 19489088
  citation: Jung SH, Song SH, Kim SD, Lee K, Lee GC. Does virtual reality training using the Xbox Kinect have a positive effect on physical functioning in children with spastic cerebral palsy? A case series. J Pediatr Rehabil Med. 2018;11(2):95-101. doi: 10.3233/PRM-160415.
  PMID: 30010148
  responsible party type: Principal Investigator
  investigator affiliation: Uludag University
  investigator full name: Cetin Sayaca
  investigator title: Principal Investigator; Assos. Prof.
  mesh term: Paralysis
  mesh term: Cerebral Palsy
  sharing ipd: No