<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/NCT01700153</url>
  </required_header>
  <id_info>
    <org_study_id>IONS-Gilliaux-01</org_study_id>
    <nct_id>NCT01700153</nct_id>
  </id_info>
  <brief_title>Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy</brief_title>
  <official_title>Study of the Effectiveness of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy by Evaluating the 3 Fields of the ICF: A Prospective, Randomized, Controlled, Simple Blind Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cerebral Palsy (CP) is a major cause of impairments in child population. This disease&#xD;
      justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised&#xD;
      by robotics.&#xD;
&#xD;
      Our team has developed a robot designed to rehabilitate the child's upper limb. This robot&#xD;
      allows the patient to perform active, passive, or assisted exercises.&#xD;
&#xD;
      This therapy is designed to promote motor development in children with CP. Its finality is to&#xD;
      improve patients' quality of life and participation.&#xD;
&#xD;
      Several pilot studies evaluated the efficacy of robotic assisted therapy in children with CP&#xD;
      but none RCT has been done.&#xD;
&#xD;
      Then, the aim of the study is to evaluate the efficacy of robotic-assisted therapy in&#xD;
      children with cerebral palsy by evaluating the 3 fields of the ICF (International&#xD;
      Classification of Functioning, Disability and Health) and performing a prospective randomized&#xD;
      controlled single blind trial. Therefore, all patients will benefit from a classical&#xD;
      rehabilitation as a basis. Furthermore, patients of the control and experimental groups will&#xD;
      receive a supplement of classical rehabilitation and robotic-assisted therapy, respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION&#xD;
&#xD;
      Cerebral Palsy (CP) is a major cause of impairments in child population. Indeed, CP affects&#xD;
      two births per thousand (1). The brain damage is expressed by different neurological&#xD;
      impairments and functional disabilities. These disabilities justify intensive and sustained&#xD;
      multidisciplinary rehabilitation to reduce neurological impairments, to improve the&#xD;
      activities and participation of patients, and, ultimately, their quality of life (2, 3, 4).&#xD;
&#xD;
      Robotics interest has already been shown for lower limb rehabilitation (5). The development&#xD;
      of the upper limb rehabilitation robotic devices started later. To better stimulate brain&#xD;
      plasticity, these tools meet the actual recommendations existing in CP's rehabilitation (4).&#xD;
      Indeed, the robots allow the execution of a large number of movements whose quality is&#xD;
      controlled (6). A visual interface gives the patient a feedback of its movements (7), and&#xD;
      offers exercises oriented functional tasks that have meaning for him (8) and the possibly&#xD;
      dive into a virtual reality. All these elements justify the clinical development of robots to&#xD;
      assist the therapists.&#xD;
&#xD;
      In children with CP, several pilot studies have verified the clinical applicability of these&#xD;
      tools (9-11). However, no randomized controlled study has been performed to evaluate the&#xD;
      effectiveness of robotic-assisted therapy in children with CP (12). Moreover, no study&#xD;
      evaluated the effect of these therapies on the three areas of the ICF : Many studies focus on&#xD;
      impairments (e.g. muscle) without assessing the functional capacity of the patient: what&#xD;
      about their ability in every day life?&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
      To perform a prospective, randomized, controlled, single blind trial to assess the efficacy&#xD;
      of robotic-assisted therapy in children with cerebral palsy by evaluating the three fields of&#xD;
      the ICF.&#xD;
&#xD;
      METHODS&#xD;
&#xD;
      Twenty patients enrolled at the &quot;Institut Royal de l'Accueil du Handicap Moteur&quot; (IRAHM)&#xD;
      (1200 Brussels) will be included according to the following criteria: CP, whose location is&#xD;
      unilateral (hemiplegia) or bilateral (diplegia, quadriplegia), with a MACS (Manual Ability&#xD;
      Classification System) score &gt; 1 (moderate to severe motor impairments) (13). The exclusion&#xD;
      criteria are the following: injection in the upper member of botulinum toxin within 6 months&#xD;
      or intrathecal baclofen used for the upper limb, an unstable clinical condition&#xD;
      contraindicating the upper limb rehabilitation treatments, cognitive disorders preventing the&#xD;
      understanding of the instructions or other neurological or orthopedic pathology affecting the&#xD;
      upper limb.&#xD;
&#xD;
      A randomisation of patients in two groups (control and experimental) will be performed, using&#xD;
      a stratified randomization method to ensure the equivalence of the two groups for age, the&#xD;
      location of the symptoms (diplegia, quadriplegia, left or right hemiplegia) and motor&#xD;
      neurological impairments (MACS score).&#xD;
&#xD;
      At IRAHM, each child benefits of 3 physiotherapy sessions and 2 occupational therapy sessions&#xD;
      per week. Each session lasts 45 minutes. The children in the control group will see no change&#xD;
      in their treatment. In the experimental group, 1 physiotherapy session and 1 occupational&#xD;
      therapy session will be replaced by two sessions of intensive rehabilitation of the arm with&#xD;
      the robot. In total for each group, each child will benefit from 40 sessions of 45 minutes&#xD;
      over 8 weeks therapy&#xD;
&#xD;
      Patients will be evaluated three times in the study: before the start of treatments, at the&#xD;
      end of treatments, and 3 months after the end of treatments.&#xD;
&#xD;
      Functional assessments will be carried out according to a protocol exploring the three fields&#xD;
      of the ICF. Impairments will be evaluated by the score of Quality of Upper Extremity Skills&#xD;
      Test (14), MACS (13), and the Box and Block test (15). Then, spasticity (with two scales),&#xD;
      kinematics and strength of the paretic arm will be evaluated using the modified Ashworth and&#xD;
      Tardieu scales, the ReaPLAN robot and a dynamometer, respectively (9, 16, 17). Disability&#xD;
      will be evaluated via Abilhand-kids (18) and Pediatric Evaluation of Disability Inventory&#xD;
      (19). Participation restrictions will be evaluated via the MHAVIE questionnaire (20). All&#xD;
      assessments will be carried out by a occupational therapist, which will be not informed the&#xD;
      group that the child is assigned (single-blind). All rehabilitation and assessment sessions&#xD;
      will be conducted at the IRAHM.&#xD;
&#xD;
      PERSPECTIVES&#xD;
&#xD;
      From this study, we hope to demonstrate the efficacy of robotic-assisted therapy in children&#xD;
      with cerebral palsy by evaluating the three fields of the ICF. These results could prove that&#xD;
      this tool can be a significant complement for the CP rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>
  </study_design_info>
  <primary_outcome>
    <measure>Kinematic</measure>
    <time_frame>Change from Baseline in Kinematic at an expected average of 3 months and 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Manual Ability Classification System</measure>
    <time_frame>Change from Baseline in manual ability at an expected average of 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Upper Extremity Skills Test</measure>
    <time_frame>Change from Baseline in quality of upper extremity skills at an expected average of 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and Block test</measure>
    <time_frame>Change from Baseline in dexterity at an expected average of 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>strength</measure>
    <time_frame>Change from Baseline in strength at an expected average of 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abilhand-Kids scale</measure>
    <time_frame>Change from Baseline in activity of daily living at an expected average of 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Evaluation of Disability Inventory</measure>
    <time_frame>Change from Baseline in activity of daily living at an expected average of 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MHAVIE</measure>
    <time_frame>Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Experimental: Robotic-assisted therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of robotic-assisted therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Classical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of classical rehabilitation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Robotic-assisted therapy</intervention_name>
    <description>This robotic device is designed to intensively rehabilitate the upper limb. Indeed, this robot allows the patient to perform a lot of active, passive, or assisted exercises. The level of assistance is determined and provided by the robot in function of the patient capacity.</description>
    <arm_group_label>Experimental: Robotic-assisted therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Classical therapy</intervention_name>
    <description>conventional therapy will be performed by therapists specialized in neuro-pediatric rehabilitation</description>
    <arm_group_label>Classical therapy</arm_group_label>
    <arm_group_label>Experimental: Robotic-assisted therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cerebral palsy (hemi, quadri or di-plegia)&#xD;
&#xD;
          -  MACS &gt; 1/5 (moderate to severe impairments)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Botulinum toxin injection in the upper limb muscles&#xD;
&#xD;
          -  Intrathecal Baclofen for the upper limb spasticity&#xD;
&#xD;
          -  an unstable clinical condition contraindicating the upper limb rehabilitation&#xD;
             treatments&#xD;
&#xD;
          -  cognitive disorders preventing the understanding of the instructions&#xD;
&#xD;
          -  other neurological or orthopedic pathology affecting the upper limb.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maxime Gilliaux, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université Catholique de Louvain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut royal de l'accueil du handicap moteur</name>
      <address>
        <city>Brussel</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Bax MC, Flodmark O, Tydeman C. Definition and classification of cerebral palsy. From syndrome toward disease. Dev Med Child Neurol Suppl. 2007 Feb;109:39-41. No abstract available.</citation>
    <PMID>17370481</PMID>
  </reference>
  <reference>
    <citation>Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.</citation>
    <PMID>16120836</PMID>
  </reference>
  <reference>
    <citation>Ward NS. The neural substrates of motor recovery after focal damage to the central nervous system. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S30-5. doi: 10.1016/j.apmr.2006.08.334.</citation>
    <PMID>17140877</PMID>
  </reference>
  <reference>
    <citation>Aisen ML, Kerkovich D, Mast J, Mulroy S, Wren TA, Kay RM, Rethlefsen SA. Cerebral palsy: clinical care and neurological rehabilitation. Lancet Neurol. 2011 Sep;10(9):844-52. doi: 10.1016/S1474-4422(11)70176-4.</citation>
    <PMID>21849165</PMID>
  </reference>
  <reference>
    <citation>Mehrholz J, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006185. doi: 10.1002/14651858.CD006185.pub2.</citation>
    <PMID>17943893</PMID>
  </reference>
  <reference>
    <citation>Masiero S, Celia A, Rosati G, Armani M. Robotic-assisted rehabilitation of the upper limb after acute stroke. Arch Phys Med Rehabil. 2007 Feb;88(2):142-9. doi: 10.1016/j.apmr.2006.10.032.</citation>
    <PMID>17270510</PMID>
  </reference>
  <reference>
    <citation>Housman SJ, Scott KM, Reinkensmeyer DJ. A randomized controlled trial of gravity-supported, computer-enhanced arm exercise for individuals with severe hemiparesis. Neurorehabil Neural Repair. 2009 Jun;23(5):505-14. doi: 10.1177/1545968308331148. Epub 2009 Feb 23.</citation>
    <PMID>19237734</PMID>
  </reference>
  <reference>
    <citation>Mehrholz J, Hadrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3.</citation>
    <PMID>22696362</PMID>
  </reference>
  <reference>
    <citation>Krebs HI, Ladenheim B, Hippolyte C, Monterroso L, Mast J. Robot-assisted task-specific training in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:140-5. doi: 10.1111/j.1469-8749.2009.03416.x.</citation>
    <PMID>19740222</PMID>
  </reference>
  <reference>
    <citation>Fasoli SE, Fragala-Pinkham M, Hughes R, Hogan N, Krebs HI, Stein J. Upper limb robotic therapy for children with hemiplegia. Am J Phys Med Rehabil. 2008 Nov;87(11):929-36. doi: 10.1097/PHM.0b013e31818a6aa4.</citation>
    <PMID>18936558</PMID>
  </reference>
  <reference>
    <citation>Frascarelli F, Masia L, Di Rosa G, Cappa P, Petrarca M, Castelli E, Krebs HI. The impact of robotic rehabilitation in children with acquired or congenital movement disorders. Eur J Phys Rehabil Med. 2009 Mar;45(1):135-41.</citation>
    <PMID>19293759</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>Eliasson AC, Krumlinde-Sundholm L, Rosblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. doi: 10.1017/S0012162206001162.</citation>
    <PMID>16780622</PMID>
  </reference>
  <reference>
    <citation>Klingels K, De Cock P, Desloovere K, Huenaerts C, Molenaers G, Van Nuland I, Huysmans A, Feys H. Comparison of the Melbourne Assessment of Unilateral Upper Limb Function and the Quality of Upper Extremity Skills Test in hemiplegic CP. Dev Med Child Neurol. 2008 Dec;50(12):904-9. doi: 10.1111/j.1469-8749.2008.03123.x. Epub 2008 Sep 20.</citation>
    <PMID>18811701</PMID>
  </reference>
  <reference>
    <citation>Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.</citation>
    <PMID>8024419</PMID>
  </reference>
  <reference>
    <citation>Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.</citation>
    <PMID>3809245</PMID>
  </reference>
  <reference>
    <citation>Gilliaux M, Lejeune T, Detrembleur C, Sapin J, Dehez B, Stoquart G. A robotic device as a sensitive quantitative tool to assess upper limb impairments in stroke patients: a preliminary prospective cohort study. J Rehabil Med. 2012 Mar;44(3):210-7. doi: 10.2340/16501977-0926.</citation>
    <PMID>22367455</PMID>
  </reference>
  <reference>
    <citation>Arnould C, Penta M, Renders A, Thonnard JL. ABILHAND-Kids: a measure of manual ability in children with cerebral palsy. Neurology. 2004 Sep 28;63(6):1045-52. doi: 10.1212/01.wnl.0000138423.77640.37.</citation>
    <PMID>15452296</PMID>
  </reference>
  <reference>
    <citation>Feldman AB, Haley SM, Coryell J. Concurrent and construct validity of the Pediatric Evaluation of Disability Inventory. Phys Ther. 1990 Oct;70(10):602-10. doi: 10.1093/ptj/70.10.602.</citation>
    <PMID>2217539</PMID>
  </reference>
  <reference>
    <citation>Noreau L, Lepage C, Boissiere L, Picard R, Fougeyrollas P, Mathieu J, Desmarais G, Nadeau L. Measuring participation in children with disabilities using the Assessment of Life Habits. Dev Med Child Neurol. 2007 Sep;49(9):666-71. doi: 10.1111/j.1469-8749.2007.00666.x.</citation>
    <PMID>17718822</PMID>
  </reference>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>May 6, 2013</last_update_submitted>
  <last_update_submitted_qc>May 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</investigator_affiliation>
    <investigator_full_name>Lejeune</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Robotic-assisted therapy</keyword>
  <keyword>cerebral palsy</keyword>
  <keyword>ICF</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>
  <!-- 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/NCT01700153
org study id: IONS-Gilliaux-01
nct id: NCT01700153
lead sponsor: 
has dmc: Yes
Cerebral Palsy (CP) is a major cause of impairments in child population. This disease
      justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised
      by robotics.

      Our team has developed a robot designed to rehabilitate the child's upper limb. This robot
      allows the patient to perform active, passive, or assisted exercises.

      This therapy is designed to promote motor development in children with CP. Its finality is to
      improve patients' quality of life and participation.

      Several pilot studies evaluated the efficacy of robotic assisted therapy in children with CP
      but none RCT has been done.

      Then, the aim of the study is to evaluate the efficacy of robotic-assisted therapy in
      children with cerebral palsy by evaluating the 3 fields of the ICF (International
      Classification of Functioning, Disability and Health) and performing a prospective randomized
      controlled single blind trial. Therefore, all patients will benefit from a classical
      rehabilitation as a basis. Furthermore, patients of the control and experimental groups will
      receive a supplement of classical rehabilitation and robotic-assisted therapy, respectively.
INTRODUCTION

      Cerebral Palsy (CP) is a major cause of impairments in child population. Indeed, CP affects
      two births per thousand (1). The brain damage is expressed by different neurological
      impairments and functional disabilities. These disabilities justify intensive and sustained
      multidisciplinary rehabilitation to reduce neurological impairments, to improve the
      activities and participation of patients, and, ultimately, their quality of life (2, 3, 4).

      Robotics interest has already been shown for lower limb rehabilitation (5). The development
      of the upper limb rehabilitation robotic devices started later. To better stimulate brain
      plasticity, these tools meet the actual recommendations existing in CP's rehabilitation (4).
      Indeed, the robots allow the execution of a large number of movements whose quality is
      controlled (6). A visual interface gives the patient a feedback of its movements (7), and
      offers exercises oriented functional tasks that have meaning for him (8) and the possibly
      dive into a virtual reality. All these elements justify the clinical development of robots to
      assist the therapists.

      In children with CP, several pilot studies have verified the clinical applicability of these
      tools (9-11). However, no randomized controlled study has been performed to evaluate the
      effectiveness of robotic-assisted therapy in children with CP (12). Moreover, no study
      evaluated the effect of these therapies on the three areas of the ICF : Many studies focus on
      impairments (e.g. muscle) without assessing the functional capacity of the patient: what
      about their ability in every day life?

      OBJECTIVES

      To perform a prospective, randomized, controlled, single blind trial to assess the efficacy
      of robotic-assisted therapy in children with cerebral palsy by evaluating the three fields of
      the ICF.

      METHODS

      Twenty patients enrolled at the "Institut Royal de l'Accueil du Handicap Moteur" (IRAHM)
      (1200 Brussels) will be included according to the following criteria: CP, whose location is
      unilateral (hemiplegia) or bilateral (diplegia, quadriplegia), with a MACS (Manual Ability
      Classification System) score > 1 (moderate to severe motor impairments) (13). The exclusion
      criteria are the following: injection in the upper member of botulinum toxin within 6 months
      or intrathecal baclofen used for the upper limb, an unstable clinical condition
      contraindicating the upper limb rehabilitation treatments, cognitive disorders preventing the
      understanding of the instructions or other neurological or orthopedic pathology affecting the
      upper limb.

      A randomisation of patients in two groups (control and experimental) will be performed, using
      a stratified randomization method to ensure the equivalence of the two groups for age, the
      location of the symptoms (diplegia, quadriplegia, left or right hemiplegia) and motor
      neurological impairments (MACS score).

      At IRAHM, each child benefits of 3 physiotherapy sessions and 2 occupational therapy sessions
      per week. Each session lasts 45 minutes. The children in the control group will see no change
      in their treatment. In the experimental group, 1 physiotherapy session and 1 occupational
      therapy session will be replaced by two sessions of intensive rehabilitation of the arm with
      the robot. In total for each group, each child will benefit from 40 sessions of 45 minutes
      over 8 weeks therapy

      Patients will be evaluated three times in the study: before the start of treatments, at the
      end of treatments, and 3 months after the end of treatments.

      Functional assessments will be carried out according to a protocol exploring the three fields
      of the ICF. Impairments will be evaluated by the score of Quality of Upper Extremity Skills
      Test (14), MACS (13), and the Box and Block test (15). Then, spasticity (with two scales),
      kinematics and strength of the paretic arm will be evaluated using the modified Ashworth and
      Tardieu scales, the ReaPLAN robot and a dynamometer, respectively (9, 16, 17). Disability
      will be evaluated via Abilhand-kids (18) and Pediatric Evaluation of Disability Inventory
      (19). Participation restrictions will be evaluated via the MHAVIE questionnaire (20). All
      assessments will be carried out by a occupational therapist, which will be not informed the
      group that the child is assigned (single-blind). All rehabilitation and assessment sessions
      will be conducted at the IRAHM.

      PERSPECTIVES

      From this study, we hope to demonstrate the efficacy of robotic-assisted therapy in children
      with cerebral palsy by evaluating the three fields of the ICF. These results could prove that
      this tool can be a significant complement for the CP rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Kinematic
time frame: Change from Baseline in Kinematic at an expected average of 3 months and 6 months
measure: Manual Ability Classification System
time frame: Change from Baseline in manual ability at an expected average of 3 months and 6 months
measure: Quality of Upper Extremity Skills Test
time frame: Change from Baseline in quality of upper extremity skills at an expected average of 3 months and 6 months
measure: Box and Block test
time frame: Change from Baseline in dexterity at an expected average of 3 months and 6 months
measure: strength
time frame: Change from Baseline in strength at an expected average of 3 months and 6 months
measure: Abilhand-Kids scale
time frame: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months
measure: Pediatric Evaluation of Disability Inventory
time frame: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months
measure: MHAVIE
time frame: Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months
arm group label: Experimental: Robotic-assisted therapy
arm group type: Experimental
description: All patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of robotic-assisted therapy.
arm group label: Classical therapy
arm group type: Active Comparator
description: All patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of classical rehabilitation.
intervention type: Other
intervention name: Robotic-assisted therapy
description: This robotic device is designed to intensively rehabilitate the upper limb. Indeed, this robot allows the patient to perform a lot of active, passive, or assisted exercises. The level of assistance is determined and provided by the robot in function of the patient capacity.
arm group label: Experimental: Robotic-assisted therapy
intervention type: Other
intervention name: Classical therapy
description: conventional therapy will be performed by therapists specialized in neuro-pediatric rehabilitation
arm group label: Classical therapy
arm group label: Experimental: Robotic-assisted therapy
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: No
last name: Maxime Gilliaux, PhD student
role: Principal Investigator
affiliation: Université Catholique de Louvain
facility: 
country: Belgium
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responsible party type: Principal Investigator
investigator affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
investigator full name: Lejeune
investigator title: Professor
mesh term: Paralysis
mesh term: Cerebral Palsy