<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/NCT02966990</url>
  </required_header>
  <id_info>
    <org_study_id>PPGRDF-FMRP-USP</org_study_id>
    <nct_id>NCT02966990</nct_id>
  </id_info>
  <brief_title>Biomechanical Analysis of the Effects of Upper Limb Orthosis During the Execution of a Functional Task</brief_title>
  <official_title>Biomechanical Analysis of the Effects of Upper Limb Orthosis During the Execution of a Functional Task</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The orthotics are auxiliary therapeutic resources indicated for the relief of pain, improves&#xD;
      functional standard or correction of deformities. There is a lack of studies that analyze the&#xD;
      biomechanical changes promoted by the Orthotics in functional pattern of the upper limb. The&#xD;
      objective of this proposal is to analyse biomechanical changes in the functional upper limb&#xD;
      pattern with the use of orthoses for patients with dysfunctions arising from musculoskeletal&#xD;
      system trauma or burns, aiming to contribute with scientific evidence to clinical practice.&#xD;
      The project will analyze the changes in the pattern of the upper limb functional through the&#xD;
      use of dynamic and static Orthotics by means of kinematic and electromyographic analysis&#xD;
      while conducting a functional task. These comparisons will be carried out with and without&#xD;
      the use of functional Orthotics, and the controls are the patients themselves. Methods: 25&#xD;
      patients will be included over 18 years with malfunctions resulting from orthopaedic trauma&#xD;
      and Burns of the upper limb with indication and Orthotics for improving functional pattern.&#xD;
      For characterization of the sample will be performed: esthesiometric , hand and the&#xD;
      (Disabilities of the Arm, Shoulder and Hand) DASH Questionnaire. Biomechanical assessment&#xD;
      will be used for the analysis and electromyographic kinematics. For statistical analysis will&#xD;
      be applied the method of analysis of variance (ANOVA) for repeated measures, and when&#xD;
      necessary, the post hoc Bonferroni test. Will be adopted as significance level p ≤ 0.05.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electromyographic assessment</measure>
    <time_frame>one day</time_frame>
    <description>Muscle activity will be measured using surface EMG (TrignoTM Wireless System, Delsys, USA), collected at a sample rate of 2000 Hz.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic analysis</measure>
    <time_frame>one day</time_frame>
    <description>Movements will be recorded with a ViconTM (Oxford Metrics, UK) motion capture eight-camera system operating at a frequency of 200 Hz.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional assessment</measure>
    <time_frame>one day</time_frame>
    <description>The DASH questionnaire will be applied and Grip strength will be measured</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Orthotic Devices</condition>
  <condition>Electromyography</condition>
  <condition>Biomechanical Phenomena</condition>
  <condition>Hand</condition>
  <condition>Upper Extremity Dysfunction</condition>
  <arm_group>
    <arm_group_label>hand orthosis patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients using hand orthosis for better hand function</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hand Orthotic Devices</intervention_name>
    <description>Orthotic device made to provide the patient with better hand function</description>
    <arm_group_label>hand orthosis patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are using hand orthosis for functional purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurological problems; cognitive deficits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Flávia Ricci, MSc</last_name>
    <phone>+55 16 991058971</phone>
    <email>flavia.macedo@usp.br</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 15, 2016</last_update_submitted>
  <last_update_submitted_qc>November 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Flavia Pessoni Faleiros Macedo Ricci</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <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/NCT02966990
org study id: PPGRDF-FMRP-USP
nct id: NCT02966990
lead sponsor: 
has dmc: No
The orthotics are auxiliary therapeutic resources indicated for the relief of pain, improves
      functional standard or correction of deformities. There is a lack of studies that analyze the
      biomechanical changes promoted by the Orthotics in functional pattern of the upper limb. The
      objective of this proposal is to analyse biomechanical changes in the functional upper limb
      pattern with the use of orthoses for patients with dysfunctions arising from musculoskeletal
      system trauma or burns, aiming to contribute with scientific evidence to clinical practice.
      The project will analyze the changes in the pattern of the upper limb functional through the
      use of dynamic and static Orthotics by means of kinematic and electromyographic analysis
      while conducting a functional task. These comparisons will be carried out with and without
      the use of functional Orthotics, and the controls are the patients themselves. Methods: 25
      patients will be included over 18 years with malfunctions resulting from orthopaedic trauma
      and Burns of the upper limb with indication and Orthotics for improving functional pattern.
      For characterization of the sample will be performed: esthesiometric , hand and the
      (Disabilities of the Arm, Shoulder and Hand) DASH Questionnaire. Biomechanical assessment
      will be used for the analysis and electromyographic kinematics. For statistical analysis will
      be applied the method of analysis of variance (ANOVA) for repeated measures, and when
      necessary, the post hoc Bonferroni test. Will be adopted as significance level p ≤ 0.05.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Electromyographic assessment
time frame: one day
description: Muscle activity will be measured using surface EMG (TrignoTM Wireless System, Delsys, USA), collected at a sample rate of 2000 Hz.
measure: Kinematic analysis
time frame: one day
description: Movements will be recorded with a ViconTM (Oxford Metrics, UK) motion capture eight-camera system operating at a frequency of 200 Hz.
measure: Functional assessment
time frame: one day
description: The DASH questionnaire will be applied and Grip strength will be measured
arm group label: hand orthosis patients
arm group type: Other
description: Patients using hand orthosis for better hand function
intervention type: Device
intervention name: Hand Orthotic Devices
description: Orthotic device made to provide the patient with better hand function
arm group label: hand orthosis patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Flávia Ricci, MSc
phone: +55 16 991058971
email: flavia.macedo@usp.br
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Flavia Pessoni Faleiros Macedo Ricci
investigator title: PhD Student
sharing ipd: No