<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/NCT03780322</url>
  </required_header>
  <id_info>
    <org_study_id>ArmeoOBPIConcepcion</org_study_id>
    <nct_id>NCT03780322</nct_id>
  </id_info>
  <brief_title>Effectiveness of Armeo Spring Pediatric in Obstetric Brachial Plexus Injury</brief_title>
  <official_title>Effectiveness of Armeo Spring Pediatric in Children With Narakas I Obstetric Brachial Plexus Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sociedad Pro Ayuda del Niño Lisiado</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sociedad Pro Ayuda del Niño Lisiado</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators seek to evaluate the effectiveness of Armeo®Spring Pediatric training, as&#xD;
      compared to conventional treatment, in improving upper extremity function in children with&#xD;
      Narakas I brachial plexus injury, aged 5-8 years, using the Mallet modified scale and passive&#xD;
      range of movement, immediately post intervention and at 3 and 6 months´ follow up. The&#xD;
      investigators will also monitor the appearance of adverse effects during and post&#xD;
      intervention, with a follow up at 3 and 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstetric brachial plexus injury is caused by damage of the cervical nerve roots C5-T1 during&#xD;
      delivery. It has traditionally been treated with occupational and physical therapy during the&#xD;
      first few months, evaluating at 1, 3 and 6 months if primary surgery is required. The goal of&#xD;
      primary surgery is to repair the damaged nerve roots and restore neural function. Despite&#xD;
      surgery, a large percentage of children will remain with varying degrees of paralysis. Since&#xD;
      Narakas I (&quot;Erb's&quot;) paralysis is the most common, motor sequelae usually involve limited&#xD;
      shoulder abduction, restricted shoulder external rotation and elbow flexion contracture. This&#xD;
      sequelae requires ongoing physical and occupational therapy, especially during school age, to&#xD;
      ensure adequate upper extremity function and participation.&#xD;
&#xD;
      Armeo Spring Pediatric is a robotic tool that enables upper extremity training using virtual&#xD;
      reality. Virtual reality is usually well tolerated and highly motivating to school age&#xD;
      children. Since it's a relatively new tool, its effectiveness in the treatment of obstetric&#xD;
      brachial plexus injury has not been documented.&#xD;
&#xD;
      This study aims to evaluate the effectiveness of Armeo Spring Pediatric training as compared&#xD;
      to conventional therapy (occupational and physical therapy), in improving the upper extremity&#xD;
      function of children with Narakas I (C5-C6) obstetric brachial plexus injury.&#xD;
&#xD;
      It will study two parallel groups of children ages 5-8. Both groups will receive 45 minute&#xD;
      sessions, 3 times a week, for a total of 5 weeks (15 sessions). One group will train upper&#xD;
      extremity function using Armeo Spring Pediatric and the other group will receive occupational&#xD;
      and physical therapy, as detailed in protocol. They will be reevaluated at 3 and 6 months.&#xD;
&#xD;
      The appearance of adverse events, such as pain, fatigue or muscle contracture, will be&#xD;
      documented during intervention, post intervention, and at 3 and 6 months. In the presence of&#xD;
      one such adverse event, the training session will be suspended and the patient evaluated by&#xD;
      physiatrist or orthopedic surgeon, with treatment if necessary. If the symptoms resolve&#xD;
      before the next session, the patient will complete training as planned. If the symptoms are&#xD;
      not resolved by the next session, the patient will be removed from the clinical trial until&#xD;
      recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <phase>Phase 4</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Modified Mallet Scale</measure>
    <time_frame>0 weeks, 5 weeks, 17 weeks, 29 weeks</time_frame>
    <description>It measures arm function in 7 different positions: arm at rest, shoulder external rotation, shoulder abduction, hand to neck, hand to mouth, hand to back and supination. Each position can be given a subscore from 1 (very altered) to 5 (almost normal), with a total score of 35. A higher score means better function (closer to normal movement or position).&#xD;
In this case, the investigators will evaluate change in Modified Mallet Scale between baseline (0 weeks), post treatment (5 weeks) and follow up (17 and 29 weeks). It will take into account changes in total scores and subscores in different positions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Upper extremity passive range of movement</measure>
    <time_frame>0 weeks, 5 weeks, 17 weeks and 29 weeks</time_frame>
    <description>Will be measured by goniometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events: pain.</measure>
    <time_frame>5 weeks, 17 weeks and 29 weeks</time_frame>
    <description>Will be measured by Visual Analogue Scale. The visual analogue scale is a unidimensional measure of pain intensity. The patient marks on the line the point that they feel represents their perception of their current state. The investigator will then measure in millimeters the distance from left to right (0-100 mm) to quantify the amount of pain. A low score means less intense pain and a high score means more severe pain.&#xD;
The Visual Analogue Scale uses many formats (straight line, boxes, happy/sad faces). Because of the age of the study population in this clinical trial, the investigators have decided to use the happy/sad faces scale.&#xD;
At 5, 17 and 29 weeks, the patient will be asked to document the pain they feel at that moment, not during the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events: fatigue</measure>
    <time_frame>5 weeks, 17 weeks and 29 weeks</time_frame>
    <description>Will be measured by Borg Scale The Borg Scale is an instrument that quantifies the exertion perceived by the patient with a score from 0-10, as follows: 0 = at rest; 1 = very easy, 2 = somewhat easy, 3 = moderate; 4 = somewhat hard, 5-6 = hard; 7-8 = really, really hard; 8-9 = really, really, really hard; 10 = maximal effort.&#xD;
At 5 weeks, the patient will be asked to document the fatigue they felt during the treatment.&#xD;
At 17 and 29 weeks, they will be asked to document the fatigue they feel at that moment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events: muscle contracture</measure>
    <time_frame>5 weeks, 17 weeks and 29 weeks</time_frame>
    <description>Will only be recorded if present/absent, since there is no scale to measure it</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Brachial Plexus Neuropathies</condition>
  <condition>Brachial Plexus Birth Palsy</condition>
  <arm_group>
    <arm_group_label>Armeo Spring Pediatric</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive training with Armeo Spring Pediatric in 45 minute sessions, 3 times a week, for a total of 15 sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional physical and occupational therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive combined physical and occupational therapy in 45 minute sessions, 3 times a week, for a total of 15 sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Armeo Spring Pediatric</intervention_name>
    <description>Before intervention, the robotic device will be adjusted to the user's unique dimensions to avoid injury.&#xD;
Each 45 minute session will include active upper extremity shoulder abduction, shoulder external rotation and/or elbow extension exercises, led by virtual reality game and supported by robotic arm. Sessions will take place 3 times a week for a total of 15 sessions.</description>
    <arm_group_label>Armeo Spring Pediatric</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional physical and occupational therapy</intervention_name>
    <description>Conventional therapy will combine physical and occupational therapy, including the following activities:&#xD;
Upper extremity weight bearing exercises.&#xD;
Approximation techniques on wrist, elbow and shoulder.&#xD;
Proprioceptive neuromuscular facilitation: shoulder flection, adduction and external rotation and shoulder flection, abduction and external rotation.&#xD;
Scapulothoracic joint mobilization.&#xD;
Stretching of shoulder abductors and external rotators.&#xD;
Hand/wrist facilitation exercises (with ball). This will be carried out in 45 minute sessions, 3 times a week, for a total of 15 sessions.</description>
    <arm_group_label>Conventional physical and occupational therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages between 5 and 8 years 11 months at beginning of intervention&#xD;
&#xD;
          -  Obstetric brachial plexus injury classified as Narakas I&#xD;
&#xD;
          -  Legal guardian signs informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evident shoulder or elbow dislocation during physical or radiological examination&#xD;
&#xD;
          -  Elbow flexion contracture of 40º or more&#xD;
&#xD;
          -  Pain during shoulder or elbow manipulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ines Salas, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sociedad Pro Ayuda del Niño Lisiado</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Teleton</name>
      <address>
        <city>Concepcion</city>
        <state>Biobio</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <reference>
    <citation>Evans-Jones G, Kay SP, Weindling AM, Cranny G, Ward A, Bradshaw A, Hernon C. Congenital brachial palsy: incidence, causes, and outcome in the United Kingdom and Republic of Ireland. Arch Dis Child Fetal Neonatal Ed. 2003 May;88(3):F185-9. doi: 10.1136/fn.88.3.f185.</citation>
    <PMID>12719390</PMID>
  </reference>
  <reference>
    <citation>Varas et al, Eventos Adversos Perinatales: Indicadores epidemiológicos, Revista Obstetricia y Ginecología 2008: 3 (2): 117-122.9</citation>
  </reference>
  <reference>
    <citation>Al-Qattan MM, El-Sayed AA, Al-Zahrani AY, Al-Mutairi SA, Al-Harbi MS, Al-Mutairi AM, Al-Kahtani FS. Narakas classification of obstetric brachial plexus palsy revisited. J Hand Surg Eur Vol. 2009 Dec;34(6):788-91. doi: 10.1177/1753193409348185. Epub 2009 Sep 28.</citation>
    <PMID>19786407</PMID>
  </reference>
  <reference>
    <citation>Vaquero G, Ramos A, Martinez JC, Valero P, Nunez-Enamorado N, Simon-De Las Heras R, Camacho-Salas A. [Obstetric brachial plexus palsy: incidence, monitoring of progress and prognostic factors]. Rev Neurol. 2017 Jul 1;65(1):19-25. Spanish.</citation>
    <PMID>28650063</PMID>
  </reference>
  <reference>
    <citation>Andersen J, Watt J, Olson J, Van Aerde J. Perinatal brachial plexus palsy. Paediatr Child Health. 2006 Feb;11(2):93-100. doi: 10.1093/pch/11.2.93.</citation>
    <PMID>19030261</PMID>
  </reference>
  <reference>
    <citation>Corkum JP, Kuta V, Tang DT, Bezuhly M. Sensory outcomes following brachial plexus birth palsy: A systematic review. J Plast Reconstr Aesthet Surg. 2017 Aug;70(8):987-995. doi: 10.1016/j.bjps.2017.05.007. Epub 2017 May 18.</citation>
    <PMID>28602269</PMID>
  </reference>
  <reference>
    <citation>El-Shamy S, Alsharif R. Effect of virtual reality versus conventional physiotherapy on upper extremity function in children with obstetric brachial plexus injury. J Musculoskelet Neuronal Interact. 2017 Dec 1;17(4):319-326.</citation>
    <PMID>29199193</PMID>
  </reference>
  <reference>
    <citation>Pellegrino G. Eficacia del tratamiento conservador en niños con parálisis braquial obstétrica. Una revisión bibliográfica. [Tesis para optar al grado de fisioterapeuta]. Tenerife España: Universidad de la Laguna; 2018. 46 p.</citation>
  </reference>
  <reference>
    <citation>Arad E, Stephens D, Curtis CG, Clarke HM. Botulinum toxin for the treatment of motor imbalance in obstetrical brachial plexus palsy. Plast Reconstr Surg. 2013 Jun;131(6):1307-1315. doi: 10.1097/PRS.0b013e31828bd487.</citation>
    <PMID>23714792</PMID>
  </reference>
  <reference>
    <citation>Yanes V, Sandobal E, Camero D, Ojeda L. Parálisis braquial obstétrica en el contexto de la rehabilitación física temprana. MediSur. 2014; 12(4): 635-649</citation>
  </reference>
  <reference>
    <citation>Gonzalez JC, Pulido JC, Fernandez F, Suarez-Mejias C. Planning, execution and monitoring of physical rehabilitation therapies with a robotic architecture. Stud Health Technol Inform. 2015;210:339-43.</citation>
    <PMID>25991162</PMID>
  </reference>
  <reference>
    <citation>Sladekova N, Kresanek J. Case report of a patient with cerebral palsy using non-robotic equipment for reeducation movements of paretic upper limb. Prz Med Uniw Rzesz Inst Leków 2014;(1):115-118</citation>
  </reference>
  <reference>
    <citation>Padyšaková H, Repková A, Sládeková N, Žiaková E, Pacek O, Musilová E, Klobucka S. Re-Education Movements of the Paretic Upper Extremity in Children age by Using Non-robotic Equipment. European Journal of Medicine 2015;8(2):106-114</citation>
  </reference>
  <reference>
    <citation>Lum PS, Burgar CG, Shor PC, Majmundar M, Van der Loos M. Robot-assisted movement training compared with conventional therapy techniques for the rehabilitation of upper-limb motor function after stroke. Arch Phys Med Rehabil. 2002 Jul;83(7):952-9. doi: 10.1053/apmr.2001.33101.</citation>
    <PMID>12098155</PMID>
  </reference>
  <reference>
    <citation>Ladenheim B, Altenburger P, Cardinal R, Monterroso L, Dierks T, Mast J, Krebs HI. The effect of random or sequential presentation of targets during robot-assisted therapy on children. NeuroRehabilitation. 2013;33(1):25-31. doi: 10.3233/NRE-130924.</citation>
    <PMID>23949025</PMID>
  </reference>
  <reference>
    <citation>You SH, Jang SH, Kim YH, Kwon YH, Barrow I, Hallett M. Cortical reorganization induced by virtual reality therapy in a child with hemiparetic cerebral palsy. Dev Med Child Neurol. 2005 Sep;47(9):628-35.</citation>
    <PMID>16138671</PMID>
  </reference>
  <reference>
    <citation>van der Sluijs JA, van Doorn-Loogman MH, Ritt MJ, Wuisman PI. Interobserver reliability of the Mallet score. J Pediatr Orthop B. 2006 Sep;15(5):324-7. doi: 10.1097/01202412-200609000-00004.</citation>
    <PMID>16891958</PMID>
  </reference>
  <reference>
    <citation>Alba-Martín, R. Fiabilidad y validez de las mediciones en hombro y codo: análisis de una aplicación de Android y un goniómetro. Rehabilitación 2016;50(2): 71-74</citation>
  </reference>
  <reference>
    <citation>Quincho, F. A., Cruz-Castillo, A. A., &amp; Moscoso-Porras, M. G. Fiabilidad y validez de las mediciones en hombro y codo: análisis de una aplicación de Android y un goniómetro. Rehabilitación 2017; 51 (2):137</citation>
  </reference>
  <reference>
    <citation>Cole T, Robinson L, Romero L, O'Brien L. Effectiveness of interventions to improve therapy adherence in people with upper limb conditions: A systematic review. J Hand Ther. 2019 Apr-Jun;32(2):175-183.e2. doi: 10.1016/j.jht.2017.11.040. Epub 2017 Dec 29.</citation>
    <PMID>29292028</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 20, 2022</last_update_submitted>
  <last_update_submitted_qc>January 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sociedad Pro Ayuda del Niño Lisiado</investigator_affiliation>
    <investigator_full_name>Leslie Stuardo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>brachial plexus birth palsy</keyword>
  <keyword>Armeo®Spring Pediatric</keyword>
  <keyword>physical therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brachial Plexus Neuropathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03780322
org study id: ArmeoOBPIConcepcion
nct id: NCT03780322
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators seek to evaluate the effectiveness of Armeo®Spring Pediatric training, as
      compared to conventional treatment, in improving upper extremity function in children with
      Narakas I brachial plexus injury, aged 5-8 years, using the Mallet modified scale and passive
      range of movement, immediately post intervention and at 3 and 6 months´ follow up. The
      investigators will also monitor the appearance of adverse effects during and post
      intervention, with a follow up at 3 and 6 months.
Obstetric brachial plexus injury is caused by damage of the cervical nerve roots C5-T1 during
      delivery. It has traditionally been treated with occupational and physical therapy during the
      first few months, evaluating at 1, 3 and 6 months if primary surgery is required. The goal of
      primary surgery is to repair the damaged nerve roots and restore neural function. Despite
      surgery, a large percentage of children will remain with varying degrees of paralysis. Since
      Narakas I ("Erb's") paralysis is the most common, motor sequelae usually involve limited
      shoulder abduction, restricted shoulder external rotation and elbow flexion contracture. This
      sequelae requires ongoing physical and occupational therapy, especially during school age, to
      ensure adequate upper extremity function and participation.

      Armeo Spring Pediatric is a robotic tool that enables upper extremity training using virtual
      reality. Virtual reality is usually well tolerated and highly motivating to school age
      children. Since it's a relatively new tool, its effectiveness in the treatment of obstetric
      brachial plexus injury has not been documented.

      This study aims to evaluate the effectiveness of Armeo Spring Pediatric training as compared
      to conventional therapy (occupational and physical therapy), in improving the upper extremity
      function of children with Narakas I (C5-C6) obstetric brachial plexus injury.

      It will study two parallel groups of children ages 5-8. Both groups will receive 45 minute
      sessions, 3 times a week, for a total of 5 weeks (15 sessions). One group will train upper
      extremity function using Armeo Spring Pediatric and the other group will receive occupational
      and physical therapy, as detailed in protocol. They will be reevaluated at 3 and 6 months.

      The appearance of adverse events, such as pain, fatigue or muscle contracture, will be
      documented during intervention, post intervention, and at 3 and 6 months. In the presence of
      one such adverse event, the training session will be suspended and the patient evaluated by
      physiatrist or orthopedic surgeon, with treatment if necessary. If the symptoms resolve
      before the next session, the patient will complete training as planned. If the symptoms are
      not resolved by the next session, the patient will be removed from the clinical trial until
      recovery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Modified Mallet Scale
time frame: 0 weeks, 5 weeks, 17 weeks, 29 weeks
description: It measures arm function in 7 different positions: arm at rest, shoulder external rotation, shoulder abduction, hand to neck, hand to mouth, hand to back and supination. Each position can be given a subscore from 1 (very altered) to 5 (almost normal), with a total score of 35. A higher score means better function (closer to normal movement or position).
In this case, the investigators will evaluate change in Modified Mallet Scale between baseline (0 weeks), post treatment (5 weeks) and follow up (17 and 29 weeks). It will take into account changes in total scores and subscores in different positions.
measure: Upper extremity passive range of movement
time frame: 0 weeks, 5 weeks, 17 weeks and 29 weeks
description: Will be measured by goniometry
measure: Adverse events: pain.
time frame: 5 weeks, 17 weeks and 29 weeks
description: Will be measured by Visual Analogue Scale. The visual analogue scale is a unidimensional measure of pain intensity. The patient marks on the line the point that they feel represents their perception of their current state. The investigator will then measure in millimeters the distance from left to right (0-100 mm) to quantify the amount of pain. A low score means less intense pain and a high score means more severe pain.
The Visual Analogue Scale uses many formats (straight line, boxes, happy/sad faces). Because of the age of the study population in this clinical trial, the investigators have decided to use the happy/sad faces scale.
At 5, 17 and 29 weeks, the patient will be asked to document the pain they feel at that moment, not during the treatment.
measure: Adverse events: fatigue
time frame: 5 weeks, 17 weeks and 29 weeks
description: Will be measured by Borg Scale The Borg Scale is an instrument that quantifies the exertion perceived by the patient with a score from 0-10, as follows: 0 = at rest; 1 = very easy, 2 = somewhat easy, 3 = moderate; 4 = somewhat hard, 5-6 = hard; 7-8 = really, really hard; 8-9 = really, really, really hard; 10 = maximal effort.
At 5 weeks, the patient will be asked to document the fatigue they felt during the treatment.
At 17 and 29 weeks, they will be asked to document the fatigue they feel at that moment.
measure: Adverse events: muscle contracture
time frame: 5 weeks, 17 weeks and 29 weeks
description: Will only be recorded if present/absent, since there is no scale to measure it
arm group label: Armeo Spring Pediatric
arm group type: Experimental
description: This group will receive training with Armeo Spring Pediatric in 45 minute sessions, 3 times a week, for a total of 15 sessions
arm group label: Conventional physical and occupational therapy
arm group type: Active Comparator
description: This group will receive combined physical and occupational therapy in 45 minute sessions, 3 times a week, for a total of 15 sessions.
intervention type: Device
intervention name: Armeo Spring Pediatric
description: Before intervention, the robotic device will be adjusted to the user's unique dimensions to avoid injury.
Each 45 minute session will include active upper extremity shoulder abduction, shoulder external rotation and/or elbow extension exercises, led by virtual reality game and supported by robotic arm. Sessions will take place 3 times a week for a total of 15 sessions.
arm group label: Armeo Spring Pediatric
intervention type: Other
intervention name: Conventional physical and occupational therapy
description: Conventional therapy will combine physical and occupational therapy, including the following activities:
Upper extremity weight bearing exercises.
Approximation techniques on wrist, elbow and shoulder.
Proprioceptive neuromuscular facilitation: shoulder flection, adduction and external rotation and shoulder flection, abduction and external rotation.
Scapulothoracic joint mobilization.
Stretching of shoulder abductors and external rotators.
Hand/wrist facilitation exercises (with ball). This will be carried out in 45 minute sessions, 3 times a week, for a total of 15 sessions.
arm group label: Conventional physical and occupational therapy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: No
last name: Ines Salas, MD
role: Study Chair
affiliation: Sociedad Pro Ayuda del Niño Lisiado
facility: 
country: Chile
citation: Evans-Jones G, Kay SP, Weindling AM, Cranny G, Ward A, Bradshaw A, Hernon C. Congenital brachial palsy: incidence, causes, and outcome in the United Kingdom and Republic of Ireland. Arch Dis Child Fetal Neonatal Ed. 2003 May;88(3):F185-9. doi: 10.1136/fn.88.3.f185.
PMID: 12719390
citation: Varas et al, Eventos Adversos Perinatales: Indicadores epidemiológicos, Revista Obstetricia y Ginecología 2008: 3 (2): 117-122.9
citation: Al-Qattan MM, El-Sayed AA, Al-Zahrani AY, Al-Mutairi SA, Al-Harbi MS, Al-Mutairi AM, Al-Kahtani FS. Narakas classification of obstetric brachial plexus palsy revisited. J Hand Surg Eur Vol. 2009 Dec;34(6):788-91. doi: 10.1177/1753193409348185. Epub 2009 Sep 28.
PMID: 19786407
citation: Vaquero G, Ramos A, Martinez JC, Valero P, Nunez-Enamorado N, Simon-De Las Heras R, Camacho-Salas A. [Obstetric brachial plexus palsy: incidence, monitoring of progress and prognostic factors]. Rev Neurol. 2017 Jul 1;65(1):19-25. Spanish.
PMID: 28650063
citation: Andersen J, Watt J, Olson J, Van Aerde J. Perinatal brachial plexus palsy. Paediatr Child Health. 2006 Feb;11(2):93-100. doi: 10.1093/pch/11.2.93.
PMID: 19030261
citation: Corkum JP, Kuta V, Tang DT, Bezuhly M. Sensory outcomes following brachial plexus birth palsy: A systematic review. J Plast Reconstr Aesthet Surg. 2017 Aug;70(8):987-995. doi: 10.1016/j.bjps.2017.05.007. Epub 2017 May 18.
PMID: 28602269
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responsible party type: Principal Investigator
investigator affiliation: Sociedad Pro Ayuda del Niño Lisiado
investigator full name: Leslie Stuardo
investigator title: Principal Investigator
mesh term: Brachial Plexus Neuropathies
sharing ipd: No