<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/NCT04412603</url>
  </required_header>
  <id_info>
    <org_study_id>Obstetric Brachial Palsy</org_study_id>
    <nct_id>NCT04412603</nct_id>
  </id_info>
  <brief_title>Emergent Therapies in OBP. Pilot Study</brief_title>
  <official_title>Conventional Mirror Therapy and Mirror Therapy Virtual Reality in Obstetric Brachial Palsy: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CEU San Pablo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CEU San Pablo 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>
      Obstetric Brachial Palsy (OBP) produces functional limitations in the involvement of the&#xD;
      affected upper limb within the child's natural environment. The therapeutic interventions of&#xD;
      Conventional Mirror Therapy (MT) and Mirror Therapy Virtual Reality (VR) are aimed at the&#xD;
      rehabilitation of the affected upper limb and the quality life improvement.&#xD;
&#xD;
      To quantify the increase in the affected upper limb spontaneous use and the quality of life&#xD;
      of children with upper OBP from 6-12 years, when They are treated with Conventional MT or&#xD;
      Mirror Therapy VR applying specific protocol: 20 min/day in 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention protocol was permorfed for four weeks, three days per week applying&#xD;
      Conventional Mirror Therapy or Mirror Therapy Virtual Reality, with 20-minute sessions in 4&#xD;
      weeks. Designed to be done at home.&#xD;
&#xD;
      Two measurements of the affected upper limb spontaneous use and quality of life were&#xD;
      performed, a pre-treatment assessment corresponding to the baseline situation, and another&#xD;
      post-treatment Assessment to observe the results after the therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2020</start_date>
  <completion_date type="Actual">April 28, 2020</completion_date>
  <primary_completion_date type="Actual">April 5, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A pilot randomized clinical trial was performed with simple blind and randomization of block assignmen.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Children's Hand-use Experience Questionnaire</measure>
    <time_frame>Four weeks</time_frame>
    <description>To measure the affected upper limb spontaneous use, validated for children with unilateral involvement or disuse of one of their upper limbs from 6 to 18 years in which the experience of children using the affectected upper limb.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pediatric Quality of Life Inventory Generic Core Scales PedsQLTM 4.0</measure>
    <time_frame>Four weeks</time_frame>
    <description>Modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Neonatal Brachial Plexus Palsy</condition>
  <arm_group>
    <arm_group_label>Conventional Mirror Therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapy:&#xD;
-With the affected upper limb into the mirror box, perform the exercise with the non-affected extremity which is reflected in the mirror box. -The affected side must perform the corresponding movement within its possibilities, according to the exercise that is being performed with the healthy arm. - It is very important to look at the mirror at all times, which reflects the non-affected side while doing the exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirror Therapy Virtual Reality group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapy:&#xD;
-Perform the exercises with the non-affected limb, which must be watched constantly with virtual reality glasses, to interpret that this limb corresponds to the affected side. - The affected side accompanies the movement within its possibilities (out of sight of the patient, it can be covered with a handkerchief). - It is very important to look at the non-affected side. The affected side should be out of the visual field to avoid confusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Mirror Therapy</intervention_name>
    <description>The Conventional Mirror Therapy was carried out with a mirror box and the Mirror Therapy Virtual Reality was carried out with virtual reality glasses and mobile application: Mirror Therapy VR.</description>
    <arm_group_label>Conventional Mirror Therapy group</arm_group_label>
    <arm_group_label>Mirror Therapy Virtual Reality group</arm_group_label>
    <other_name>Mirror Therapy Virtual Reality</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages between 6 and 12 years old, upper Obstetric Brachial Palsy type Erb-Duchenne&#xD;
             (C5-C6) and extended Erb-Duchenne (C5-C7), preserved functionality to do the&#xD;
             activities, adequate cognitive level to follow the proposed activities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  associated pathologies, medical complications or cognitive and / or visual impairment&#xD;
             that prevent the activities performance, affected upper limb surgeries in the last&#xD;
             year, treatment with botulinum toxin in the last three months, no possession of a&#xD;
             device with Android operating system for the application of Virtual Reality therapy,&#xD;
             families and children no partners.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rocío Palomo, Physiotherapist</last_name>
    <role>Study Director</role>
    <affiliation>San Pablo-CEU Univerity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Pablo-CEU Univerity</name>
      <address>
        <city>Madrid</city>
        <zip>28668</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>February 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Virtual Reality.</keyword>
  <keyword>family</keyword>
  <keyword>Mirror Therapy</keyword>
  <keyword>Obstetrical Brachial Palsy</keyword>
  <keyword>Upper extremity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neonatal Brachial Plexus 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>


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/NCT04412603
org study id: Obstetric Brachial Palsy
nct id: NCT04412603
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obstetric Brachial Palsy (OBP) produces functional limitations in the involvement of the
      affected upper limb within the child's natural environment. The therapeutic interventions of
      Conventional Mirror Therapy (MT) and Mirror Therapy Virtual Reality (VR) are aimed at the
      rehabilitation of the affected upper limb and the quality life improvement.

      To quantify the increase in the affected upper limb spontaneous use and the quality of life
      of children with upper OBP from 6-12 years, when They are treated with Conventional MT or
      Mirror Therapy VR applying specific protocol: 20 min/day in 4 weeks.
The intervention protocol was permorfed for four weeks, three days per week applying
      Conventional Mirror Therapy or Mirror Therapy Virtual Reality, with 20-minute sessions in 4
      weeks. Designed to be done at home.

      Two measurements of the affected upper limb spontaneous use and quality of life were
      performed, a pre-treatment assessment corresponding to the baseline situation, and another
      post-treatment Assessment to observe the results after the therapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A pilot randomized clinical trial was performed with simple blind and randomization of block assignmen.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Children's Hand-use Experience Questionnaire
time frame: Four weeks
description: To measure the affected upper limb spontaneous use, validated for children with unilateral involvement or disuse of one of their upper limbs from 6 to 18 years in which the experience of children using the affectected upper limb.
measure: Pediatric Quality of Life Inventory Generic Core Scales PedsQLTM 4.0
time frame: Four weeks
description: Modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18.
arm group label: Conventional Mirror Therapy group
arm group type: Experimental
description: Therapy:
-With the affected upper limb into the mirror box, perform the exercise with the non-affected extremity which is reflected in the mirror box. -The affected side must perform the corresponding movement within its possibilities, according to the exercise that is being performed with the healthy arm. - It is very important to look at the mirror at all times, which reflects the non-affected side while doing the exercises.
arm group label: Mirror Therapy Virtual Reality group
arm group type: Experimental
description: Therapy:
-Perform the exercises with the non-affected limb, which must be watched constantly with virtual reality glasses, to interpret that this limb corresponds to the affected side. - The affected side accompanies the movement within its possibilities (out of sight of the patient, it can be covered with a handkerchief). - It is very important to look at the non-affected side. The affected side should be out of the visual field to avoid confusion.
intervention type: Other
intervention name: Conventional Mirror Therapy
description: The Conventional Mirror Therapy was carried out with a mirror box and the Mirror Therapy Virtual Reality was carried out with virtual reality glasses and mobile application: Mirror Therapy VR.
arm group label: Conventional Mirror Therapy group
arm group label: Mirror Therapy Virtual Reality group
other name: Mirror Therapy Virtual Reality
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rocío Palomo, Physiotherapist
role: Study Director
affiliation: San Pablo-CEU Univerity
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Neonatal Brachial Plexus Palsy
sharing ipd: No