<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/NCT03815734</url>
  </required_header>
  <id_info>
    <org_study_id>SALUDDOCTORADO</org_study_id>
    <nct_id>NCT03815734</nct_id>
  </id_info>
  <brief_title>Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period</brief_title>
  <official_title>Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eva Prado Robles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de León</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>
      The aim of this study is to verify whether after trapeziometacarpal osteoarthrosis surgery&#xD;
      and during the period of immobilization immediately after it, applying motor imagery,&#xD;
      improvements are achieved on pain, strength, edema and / or inflammation, function and the&#xD;
      joint range, accelerating the recovery process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Motor imagery (IM) consists of a complex cognitive operation by which an action is simulated&#xD;
      without doing it physically.&#xD;
&#xD;
      Many studies support the usefulness of motor imaging in rehabilitation after manual surgery.&#xD;
&#xD;
      An approach based on motor imagery may be useful in trapeziometacarpal osteoarthritis, and&#xD;
      may be used to promote motor recovery after surgical treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Preoperative pain to postoperative pain</measure>
    <time_frame>2 weeks before the surgery/5, 7 and 11 weeks after surgery</time_frame>
    <description>Visual Analogue Scale (VAS). &quot;0&quot; (better) to &quot;10&quot; (worse)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mobility of hand</measure>
    <time_frame>2 weeks before the surgery/5, 7 and 11 weeks after surgery</time_frame>
    <description>Kapandji test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint mobility</measure>
    <time_frame>2 weeks before the surgery/5, 7 and 11 weeks after surgery</time_frame>
    <description>Goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength</measure>
    <time_frame>2 weeks before the surgery/5, 7 and 11 weeks after surgery</time_frame>
    <description>Baseline Pinch Gauge, Hydraulic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Edema/inflammation</measure>
    <time_frame>2 weeks before the surgery/5, 7 and 11 weeks after surgery</time_frame>
    <description>Measuring tape. Centimeter measurement. Wrist and thumb perimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life and function</measure>
    <time_frame>2 weeks before the surgery/5, 7 and 11 weeks after surgery</time_frame>
    <description>The Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). 30-item disability/symptom scale, scored 0 (no disability) to 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual function</measure>
    <time_frame>2 weeks before the surgery/5, 7 and 11 weeks after surgery</time_frame>
    <description>The Cochin Hand Functional Scale (CHFS) questionnaire. &quot;0&quot; better to &quot;90&quot; worse</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Osteoarthritis Thumb</condition>
  <condition>Immobilization</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>motor imagery group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>motor imagery</intervention_name>
    <description>motor imagery during the postoperative immobilization period</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The participants on the surgical waiting list of the Hospital of León&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other hand pathologies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jesús Seco Calvo</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de León</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eva Prado Robles</last_name>
    <phone>+34 696903684</phone>
    <email>eprado@saludcastillayleon.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jose Angel D Gil</last_name>
    <phone>+34 649645821</phone>
    <email>eprado@saludcastillayleon.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Eva</name>
      <address>
        <city>León</city>
        <zip>24196</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eva Prado Robles</last_name>
      <phone>696903684</phone>
      <email>eprado@saludcastillayleon.es</email>
    </contact>
    <contact_backup>
      <last_name>Jose Angel Delgado Gil</last_name>
      <phone>649645821</phone>
      <email>eprado@saludcastillayleon.es</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.</citation>
    <PMID>19345768</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>February 5, 2022</last_update_submitted>
  <last_update_submitted_qc>February 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de León</investigator_affiliation>
    <investigator_full_name>Eva Prado Robles</investigator_full_name>
    <investigator_title>Principal investigator. Occupational Therapy</investigator_title>
  </responsible_party>
  <keyword>Mental practice</keyword>
  <keyword>motor imagery</keyword>
  <keyword>trapeziometacarpal osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT03815734
org study id: SALUDDOCTORADO
nct id: NCT03815734
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to verify whether after trapeziometacarpal osteoarthrosis surgery
      and during the period of immobilization immediately after it, applying motor imagery,
      improvements are achieved on pain, strength, edema and / or inflammation, function and the
      joint range, accelerating the recovery process.
Motor imagery (IM) consists of a complex cognitive operation by which an action is simulated
      without doing it physically.

      Many studies support the usefulness of motor imaging in rehabilitation after manual surgery.

      An approach based on motor imagery may be useful in trapeziometacarpal osteoarthritis, and
      may be used to promote motor recovery after surgical treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from Preoperative pain to postoperative pain
time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
description: Visual Analogue Scale (VAS). "0" (better) to "10" (worse)
measure: Mobility of hand
time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
description: Kapandji test
measure: Joint mobility
time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
description: Goniometer
measure: Strength
time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
description: Baseline Pinch Gauge, Hydraulic.
measure: Edema/inflammation
time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
description: Measuring tape. Centimeter measurement. Wrist and thumb perimeter
measure: Quality of life and function
time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
description: The Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). 30-item disability/symptom scale, scored 0 (no disability) to 100
measure: Manual function
time frame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
description: The Cochin Hand Functional Scale (CHFS) questionnaire. "0" better to "90" worse
arm group label: control group
arm group type: No Intervention
description: Non intervention group
arm group label: intervention group
arm group type: Experimental
description: motor imagery group
intervention type: Procedure
intervention name: motor imagery
description: motor imagery during the postoperative immobilization period
arm group label: intervention group
criteria: 
gender: Female
gender based: Yes
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jesús Seco Calvo
role: Study Director
affiliation: Universidad de León
last name: Eva Prado Robles
phone: +34 696903684
email: eprado@saludcastillayleon.es
last name: Jose Angel D Gil
phone: +34 649645821
email: eprado@saludcastillayleon.es
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
citation: Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.
PMID: 19345768
responsible party type: Sponsor-Investigator
investigator affiliation: Universidad de León
investigator full name: Eva Prado Robles
investigator title: Principal investigator. Occupational Therapy
mesh term: Osteoarthritis
sharing ipd: No