<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/NCT03837951</url>
  </required_header>
  <id_info>
    <org_study_id>11-056-LEW-XPD</org_study_id>
    <nct_id>NCT03837951</nct_id>
  </id_info>
  <brief_title>Figure-of-Eight Hand, Volumetric Measurements and Reliability in Clinic With Hand Injured Patients</brief_title>
  <official_title>Comparison of Figure-of-Eight Hand Measurements to Standard Volumetric Measurements and Its Reliability Within a Clinical Setting With Hand Injured Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Lowell</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Massachusetts, Lowell</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>
      This study determined the intra-rater and inter-rater reliability of the Figure-of-Eight&#xD;
      method on healthy hands, and compared the figure-of-eight measurements to the gold standard&#xD;
      volumetric measurements. Part B of the study conducted in a clinic, assessed the intra-rater&#xD;
      reliability and inter-rater reliability on both hands of patients with hand injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Edema is the retention of fluid in the intracellular spaces, which is common in inflammatory&#xD;
      condition such as traumatic injury and post surgical conditions. Edema in the hand and wrist&#xD;
      can result in detrimental physiological changes which decrease the range of motion of joint&#xD;
      and limit the overall functional capacity and dexterity of the hand. The gold standard&#xD;
      Volumetric measurements are reliable for measuring edema changes in upper extremity. Using&#xD;
      volumeters can be cumbersome in a busy clinic. Figure-of-eight measurements using a tape&#xD;
      measure on the wrist and hand is an easy way to measure edema and can capture the&#xD;
      accumulation in the dorsal hand that circumferential tape measurements do not capture. This&#xD;
      study was performed in two parts. Part A determined the intra-rater and inter-rater&#xD;
      reliability of the Figure-of-Eight method on healthy hands, and compared the figure-of-eight&#xD;
      measurements to the gold standard volumetric measurements. No study other study has compared&#xD;
      right and left hands. Part B of the study was conducted in a clinic to assess the intra-rater&#xD;
      reliability and inter-rater reliability on both hands of patients with hand injuries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 28, 2011</start_date>
  <completion_date type="Actual">April 30, 2014</completion_date>
  <primary_completion_date type="Actual">April 30, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Figure-of-Eight non-injured hands</measure>
    <time_frame>1 day</time_frame>
    <description>3 measurements of right and left hands of each non-injured participant by 3 hand therapists</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volumetric measurements on non-injured hands</measure>
    <time_frame>1 day</time_frame>
    <description>3 measurements of right and left hands of each non-injured participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Figure-of-Eight injured hands</measure>
    <time_frame>1 day</time_frame>
    <description>3 measurements of right and left hands of each non-injured participant by 3 different hand therapists</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Hand Injuries</condition>
  <condition>Edema Arm</condition>
  <arm_group>
    <arm_group_label>Uninjured hands</arm_group_label>
    <description>healthy participants without injuries to hands or wrists</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Injured hands</arm_group_label>
    <description>participants undergoing medical treatment for recent hand or wrist injury</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Figure-of-eight tape measure measurements on both hands</intervention_name>
    <description>Tape measure is wrapped around the wrist and hand and a measurement reading is taken. this is repeated 3 times.</description>
    <arm_group_label>Injured hands</arm_group_label>
    <arm_group_label>Uninjured hands</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Volumeter measurements</intervention_name>
    <description>Volumeter measurements to uninjured participants had 3 measurements taken of each hand.</description>
    <arm_group_label>Uninjured hands</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Part A: Thirty healthy participants (10 men and 20 women) were recruited from the student&#xD;
        population at a university.&#xD;
&#xD;
        Part B: 17 participants with upper extremity injury (4 men &amp; 13 women)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Healthy-part A&#xD;
&#xD;
          -  Recent history of hand or wrist injury with swelling -part B&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Open wounds-part A&#xD;
&#xD;
          -  Current swelling-part A&#xD;
&#xD;
          -  History of injury in either upper extremity-part A&#xD;
&#xD;
          -  Diabetes mellitus-part A&#xD;
&#xD;
          -  Raynaud's Syndrome-part A&#xD;
&#xD;
          -  Pregnant women-part A &amp; B&#xD;
&#xD;
          -  Could not speak English-part A &amp; B&#xD;
&#xD;
          -  Could not consent for oneself-part A &amp; B&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erika S. LEWIS, Ed.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor, University of Massachusetts Lowell</affiliation>
  </overall_official>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 29, 2020</last_update_submitted>
  <last_update_submitted_qc>March 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Lowell</investigator_affiliation>
    <investigator_full_name>ELewis</investigator_full_name>
    <investigator_title>Associate Professor, Interim DPT Program Director</investigator_title>
  </responsible_party>
  <keyword>reliability</keyword>
  <keyword>edema</keyword>
  <keyword>physical therapy</keyword>
  <keyword>occupational therapy</keyword>
  <keyword>figure-of-eight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hand Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not planning to share the de-identified data on this population</ipd_description>
  </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/NCT03837951
org study id: 11-056-LEW-XPD
nct id: NCT03837951
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study determined the intra-rater and inter-rater reliability of the Figure-of-Eight
      method on healthy hands, and compared the figure-of-eight measurements to the gold standard
      volumetric measurements. Part B of the study conducted in a clinic, assessed the intra-rater
      reliability and inter-rater reliability on both hands of patients with hand injuries.
Edema is the retention of fluid in the intracellular spaces, which is common in inflammatory
      condition such as traumatic injury and post surgical conditions. Edema in the hand and wrist
      can result in detrimental physiological changes which decrease the range of motion of joint
      and limit the overall functional capacity and dexterity of the hand. The gold standard
      Volumetric measurements are reliable for measuring edema changes in upper extremity. Using
      volumeters can be cumbersome in a busy clinic. Figure-of-eight measurements using a tape
      measure on the wrist and hand is an easy way to measure edema and can capture the
      accumulation in the dorsal hand that circumferential tape measurements do not capture. This
      study was performed in two parts. Part A determined the intra-rater and inter-rater
      reliability of the Figure-of-Eight method on healthy hands, and compared the figure-of-eight
      measurements to the gold standard volumetric measurements. No study other study has compared
      right and left hands. Part B of the study was conducted in a clinic to assess the intra-rater
      reliability and inter-rater reliability on both hands of patients with hand injuries.
observational model: Other
time perspective: Prospective
measure: Figure-of-Eight non-injured hands
time frame: 1 day
description: 3 measurements of right and left hands of each non-injured participant by 3 hand therapists
measure: Volumetric measurements on non-injured hands
time frame: 1 day
description: 3 measurements of right and left hands of each non-injured participant
measure: Figure-of-Eight injured hands
time frame: 1 day
description: 3 measurements of right and left hands of each non-injured participant by 3 different hand therapists
arm group label: Uninjured hands
description: healthy participants without injuries to hands or wrists
arm group label: Injured hands
description: participants undergoing medical treatment for recent hand or wrist injury
intervention type: Other
intervention name: Figure-of-eight tape measure measurements on both hands
description: Tape measure is wrapped around the wrist and hand and a measurement reading is taken. this is repeated 3 times.
arm group label: Injured hands
arm group label: Uninjured hands
intervention type: Other
intervention name: Volumeter measurements
description: Volumeter measurements to uninjured participants had 3 measurements taken of each hand.
arm group label: Uninjured hands
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erika S. LEWIS, Ed.D
role: Principal Investigator
affiliation: Associate Professor, University of Massachusetts Lowell
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Lowell
investigator full name: ELewis
investigator title: Associate Professor, Interim DPT Program Director
mesh term: Hand Injuries
sharing ipd: No
ipd description: Not planning to share the de-identified data on this population